Formaldehyde solution, >37% aqueous solution with >10% methanol

Substance overview Plus
Name:
Formaldehyde solution, >37% aqueous solution with >10% methanol
CAS Number:
 
Synonyms:
50-00-0, Dangerous Good; Formalin; Formaldehyde solution; Methaldehyde; Methylaldehyde; Methylene oxide; Oxomethane; Oxymethylene, Formaldehyde, Formaldehyde solution, Formalin, Methaldehyde, Methylaldehyde, Methylene oxide, Oxomethane, Oxymethylene
Approval number:
HSR001162, Approved with controls
UN Class:
Class 3: Flammable liquids; Class 8: Corrosive substances; Packing group III: Substances presenting low danger
UN Number:
1198
Molecular weight:
 
Relative density:
1.067
Water solubility:
400000 mg/L
Classification Flam. Liquid 3 Plus
Classification route species:
 
Classification description:
H226: Flammable liquid and vapour.
Classification key study:
Flash point: 60 °C
Boiling point: -20 °C
Classification Acute Tox. 3 Plus
Classification route species:
(oral)
Classification description:
H301: Toxic if swallowed.
Classification key study:

Oral Route
SPECIES: Guinea pig
ENDPOINT: LD50
VALUE: 260 mg/kg body weight
REFERENCE SOURCE: Smyth et al. (1941) [WHO EHC 1989]

Inhalation Route
SPECIES: Mouse
ENDPOINT: LC50
VALUE: 0.497 mg/l
REFERENCE SOURCE: BASF AG Ludwigshafen
R-PHRASE: R 23/24/25 Toxic by inhalation, in contact with skin and if swallowed. [IUCLID 2000]

Dermal Route
SPECIES: Rabbit
ENDPOINT: LD50
VALUE: 270 mg/kg
REFERENCE SOURCE: [NTP]

Classification Acute Tox. 3 Plus
Classification route species:
(dermal)
Classification description:
H311: Toxic in contact with skin.
Classification key study:

Oral Route
SPECIES: Guinea pig
ENDPOINT: LD50
VALUE: 260 mg/kg body weight
REFERENCE SOURCE: Smyth et al. (1941) [WHO EHC 1989]

Inhalation Route
SPECIES: Mouse
ENDPOINT: LC50
VALUE: 0.497 mg/l
REFERENCE SOURCE: BASF AG Ludwigshafen
R-PHRASE: R 23/24/25 Toxic by inhalation, in contact with skin and if swallowed. [IUCLID 2000]

Dermal Route
SPECIES: Rabbit
ENDPOINT: LD50
VALUE: 270 mg/kg
REFERENCE SOURCE: [NTP]

Classification Acute Tox. 2 Plus
Classification route species:
(inhalation)
Classification description:
H330: Fatal if inhaled.
Classification key study:

Oral Route
SPECIES: Guinea pig
ENDPOINT: LD50
VALUE: 260 mg/kg body weight
REFERENCE SOURCE: Smyth et al. (1941) [WHO EHC 1989]

Inhalation Route
SPECIES: Mouse
ENDPOINT: LC50
VALUE: 0.497 mg/l
REFERENCE SOURCE: BASF AG Ludwigshafen
R-PHRASE: R 23/24/25 Toxic by inhalation, in contact with skin and if swallowed. [IUCLID 2000]

Dermal Route
SPECIES: Rabbit
ENDPOINT: LD50
VALUE: 270 mg/kg
REFERENCE SOURCE: [NTP]

Classification Skin Corr. 1C Plus
Classification route species:
 
Classification description:
H314: Causes severe skin burns and eye damage.
Classification key study:

Skin Irritation
SPECIES: Human
RESULT: Irritating
EC CLASSIFICATION: Corrosive (causes burns)
REFERENCE SOURCE: ALDER S.p.A. TRIESTE [IUCLID 2000]
REMARK: UN class 8 PG III

Eye Irritation
SPECIES: Rabbit
RESULT: Highly irritating
REFERENCE SOURCE: PROTEX S.A LEVALLOIS PERRET (171) Griffith, John F.; Nixon, Geramd A.; Bruce, Robert D.; Reer, Paul J.; Bannan, Elmer A. (Ivorydale Tech. Cent., Procter and Gamble Co.; Cincinnati, OH 45217 USA). Toxicol. Appl. Pharmacol. 1980, 55(3), 501-13 (Eng). [IUCLID 2000]
REMARK: EC Classification: Risk of serious damage to eyes.

Classification Eye Damage 1 Plus
Classification route species:
 
Classification description:
H318: Causes serious eye damage.
Classification key study:

Skin Irritation
SPECIES: Human
RESULT: Irritating
EC CLASSIFICATION: Corrosive (causes burns)
REFERENCE SOURCE: ALDER S.p.A. TRIESTE [IUCLID 2000]
REMARK: UN class 8 PG III

Eye Irritation
SPECIES: Rabbit
RESULT: Highly irritating
REFERENCE SOURCE: PROTEX S.A LEVALLOIS PERRET (171) Griffith, John F.; Nixon, Geramd A.; Bruce, Robert D.; Reer, Paul J.; Bannan, Elmer A. (Ivorydale Tech. Cent., Procter and Gamble Co.; Cincinnati, OH 45217 USA). Toxicol. Appl. Pharmacol. 1980, 55(3), 501-13 (Eng). [IUCLID 2000]
REMARK: EC Classification: Risk of serious damage to eyes.

Classification Skin Sens. 1 Plus
Classification route species:
 
Classification description:
H317: May cause an allergic skin reaction.
Classification key study:
Contact Sensitisation
SPECIES: Guinea pig
RESULT: Sensitizing
REFERENCE SOURCE: BASF AG Ludwigshafen [IUCLID 2000]
REMARK: 6.5B at greater than or equal to 0.54%
Classification Muta. 2 Plus
Classification route species:
 
Classification description:
H341: Suspected of causing genetic defects <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Classification key study:
Genetic toxicity in Vitro: Type: Cytogenetic assay
Species: rat Sex: no data
Strain: Wistar
Route of admin.: inhalation
Exposure period: 5 d, 6 h/d
Doses: 0.1 - 20 ppm (ca. 0.0001 - 0.025 mg/l)
Result:
Method: other: ex vivo (in vitro/in vivo) chromosomal aberrations -
eukaryotes (mammalian cells)
Year: GLP: no data
Test substance: no data
Remark: Reliability: 2 (reliable with restrictions)
Result: positive
Chromosome analysis of nasal epithelial cells nasal-, maxillar- and ethmoturbinates) was performed. Application of the test substance via

Inhalation Route resulted in an increase in the number of aberrant metaphases only at a dose level of 20 ppm; additionally, a 30% reduction of the mitotic index was observed at this dose level. Positive reaction was observed in nasal- and maxillar-, but not in ethmoturbinates.
Source: BASF AG Ludwigshafen
Test substance: formaldehyde; no data on purity of the compound
Miltenburger, H.G. et al.: "Lokale Gentoxizitaet des Formaldehyd", Schriftenreihe der Bundesanstalt fuer Arbeitsschutz (1991)
[IUCLID 2000]

Genetic toxicity in Vivo: Type: Cytogenetic assay
Species: rat Sex: no data
Strain: Wistar
Route of admin.: inhalation
Exposure period: 5 d, 6 h/d
Doses: 0.1 - 20 ppm (ca. 0.0001 - 0.025 mg/l)
Result:
Method: other: ex vivo (in vitro/in vivo) chromosomal aberrations -
eukaryotes (mammalian cells)
Year: GLP: no data
Test substance: no data
Remark: Reliability: 2 (reliable with restrictions)
Result: positive
Chromosome analysis of nasal epithelial cells nasal-, maxillar- and ethmoturbinates) was performed. Application of the test substance via

Inhalation Route resulted in an increase in the number of aberrant metaphases only at a dose level of 20 ppm; additionally, a 30% reduction of the mitotic index was observed at this dose level. Positive reaction was observed in nasal- and maxillar-, but not in ethmoturbinates.
Source: BASF AG Ludwigshafen
Test substance: formaldehyde; no data on purity of the compound
Miltenburger, H.G. et al.: "Lokale Gentoxizitaet des Formaldehyd", Schriftenreihe der Bundesanstalt fuer Arbeitsschutz (1991)
[IUCLID 2000]

Classification Carc. 1 Plus
Classification route species:
 
Classification description:
H350: May cause cancer <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Classification key study:
Key information: Evaluation: There is limited evidence in humans for the carcinogenicity of formaldehyde. There is sufficient evidence in experimental animals for the carcinogenicity of formaldehyde. Overall evaluation: Formaldehyde is probably carcinogenic to humans (Group 2A).
[IARC. Monographs on the Evaluation of the Carcinogenic Risk of Chemicals to Man. Geneva: World Health Organization, International Agency for Research on Cancer,1972-PRESENT. (Multivolume work).,p. 62 336 (1995)]**QC REVIEWED**
[HSDB]

Classification STOT Rep. Exp. 2 Plus
Classification route species:
 
Classification description:
H373: May cause damage to organs <or state all organs affected, if known> through prolonged or repeated exposure <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>.
Classification key study:
Repeated dose toxicity:

Oral Route
Primary Organ Effected: Weight loss/metabolic
Secondary Organ(s) Effected: Hepatotoxicity (liver)
Renal toxicity (Kidney)
A.1. Oral RfD Summary:
Critical Effect Experimental Doses* UF MF RfD
-------------------- ----------------------- ----- --- ---------
Reduced weight gain, NOAEL: 15 mg/kg/day 100 1 2E-1
histopathology in rats mg/kg/day
LOAEL: 82 mg/kg/day
Rat 2-Year Bioassay
Til et al., 1989
--------------------------------------------------------------------------------
* Conversion Factors: none
I.A.2. Principal and Supporting Studies (Oral RfD):
Til, H.P., R.A. Woutersen, V.J. Feron, V.H.M. Hollanders, H.E. Falke and J.J.
Clary. 1989. Two-year drinking water study of formaldehyde in rats. Food
Chem. Toxicol. 27: 77-87.
Formaldehyde was administered daily in drinking water to Wistar rats
(70/sex/dose) for up to 24 months at mean doses of 0, 1.2, 15, or 82 mg/kg/day for males and 0, 1.8, 21, or 109 mg/kg/day for females. Up to 10 rats/sex/dose were sacrificed and examined after 12 months and 18 months of treatment; the remainder was sacrificed and examined at 24 months. Mean body weights of the high-dose group were decreased in males from week 1 and in females from week 24 through termination. Food intake was significantly decreased in all high-dose males with females showing a similar but less
consistent decrease in food intake. A 40% decrease in drinking water intake was reported in all high-dose animals while those rats receiving the middle dose showed a slight but generally insignificant decrease in liquid intake. Changes in urinalyses, and hematological and clinical chemistry parameters, were not dose-related, so were not considered to be related to formaldehyde intake. Among the high-dose males, significant decreases were seen in the absolute heart and liver weights at 18 months and at termination; in testes weights at 18 months; and in kidney weights at termination. High-dose females showed significant increases in the relative kidney weights at 12 and 24
months. Relative brain weights were significantly increased in high-dose males at all three examination periods and in females at termination only. Relative testes weights were significantly increased in high-dose males at termination. These relative organ weight increases were generally ascribed to the decreased body weights observed. A significant increase in mortality among males receiving the 15 mg/kg/day dose was not considered toxicologically significant. Gross examination at 12, 18, and 24 months revealed a raised, thickening of the limiting ridge of the forestomach in most high-dose rats and in some rats of both sexes from other groups. Irregular mucosal thickening of the forestomach and glandular stomach were seen in several rats of the high-dose
group and in occasional rats of other groups. The incidence of discoloration and irregularity of the kidney surface and atrophy of the testes was lower in the high-dose group as compared with controls. Significant histopathological changes of the gastrointestinal tract were found in high-dose males and females and included chronic atrophic gastritis of the glandular stomach from week 53 on, as well as focal ulceration and glandular hyperplasia at the terminal examination. The incidence of focal papillary
epithelial hyperplasia and focal hyperkeratosis of the forestomach was significantly increased in both sexes at the terminal examination. These effects of formaldehyde on the gastric mucosa were considered cytotoxic in nature. A significant increase in the incidence of papillary necrosis of the kidneys was reported in both sexes of high-dose rats at the terminal examination. No treatment-related gastric tumors were observed in this study. The incidence and type of tumors observed in other organ systems were common
to this strain and similar to those found in aging rats, 30 were not considered toxicologically s