Registration Dossier
Registration Dossier
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EC number: 200-001-8 | CAS number: 50-00-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- not specified
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- partly limited documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicity of formaldehyde in experimental animals - concentrations of the chemical in the elution from dishes of formaldehyde resin in some vegetables
- Author:
- Tsuchiya K, Hayashi Y, Onodera M, Hasegawa T
- Year:
- 1 975
- Bibliographic source:
- Kefo J Med 24: 19-37
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- no symptoms described, no necrospy
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Formaldehyde
- EC Number:
- 200-001-8
- EC Name:
- Formaldehyde
- Cas Number:
- 50-00-0
- Molecular formula:
- CH2O
- IUPAC Name:
- formaldehyde
- Details on test material:
- - Name of test material (as cited in study report): formaldehyde
Constituent 1
- Specific details on test material used for the study:
- TEST MATERIAL
- 2 and 4 % formaldehyde solution prepared from the special-grade paraformaldehyde and the commercial special-grade formalin (inludes methyl alcohol of more than 10 %)
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 100 - 200 g
- Housing: 5 rats per cage
- Diet: solid feed
ENVIRONMENTAL CONDITIONS
- Temperature: 18 - 20°C
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED
- At a dose of 675 mg/kg bw 33 mL/kg
- At a dose of 1140 mg/kg bw 28.5 mL/kg - Doses:
- 230, 300, 400, 520, 675, 875 mg/kg (2 % solution)
400, 520, 675, 875, 1140 mg/kg (4 % solution) - No. of animals per sex per dose:
- 6 - 16
- Control animals:
- no
- Details on study design:
- Duration of observation period following administration: at least one week
- Statistics:
- Litchfield method to determine LD50
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 460 mg/kg bw
- 95% CL:
- 330 - 650
- Remarks on result:
- other: 2 % test substance
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 832 mg/kg bw
- 95% CL:
- 617 - 965
- Remarks on result:
- other: 4 % test substance
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 550 mg/kg bw
- 95% CL:
- 420 - 715
- Remarks on result:
- other: 2 % test substance
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 710 mg/kg bw
- 95% CL:
- 550 - 910
- Remarks on result:
- other: 2 % test substance
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 640 mg/kg bw
- 95% CL:
- 551 - 742
- Remarks on result:
- other: 4 % test substance
- Mortality:
- Rats died in most cases within 24 h after application.
- Clinical signs:
- other: no data
- Gross pathology:
- no data
Any other information on results incl. tables
Mortality rates in male Wistar rats after oral application of formaldehyde | |||
2% formaldehyde | |||
Formalin solutions | Paraformaldehyde solutions | ||
Dose in mg/kg bw | Mortality | Dose in mg/kg bw | Mortality |
675 | 7/7 | 675 | 5/8 |
520 | 3/7 | 520 | 4/8 |
400 | 1/6 | 400 | 2/8 |
300 | 1/7 | 300 | 1/8 |
230 | 0/7 | 230 | 1/8 |
|
|
|
|
|
| 875 | 9/9 |
|
| 675 | 4/9 |
|
| 520 | 2/9 |
|
| 400 | 0/9 |
|
| 300 | 0/9 |
4% formaldehyde | |||
Formalin solutions | Paraformaldehyde solutions | ||
Dose in mg/kg bw | Mortality | Dose in mg/kg bw | Mortality |
1140 | 13/16 |
|
|
875 | 11/16 | 875 | 13/16 |
675 | 8/16 | 675 | 9/16 |
520 | 0/16 | 520 | 2/16 |
400 | 0/16 | 400 | 3/16 |
|
|
|
|
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- LD50 = 640 mg/kg bw
- Executive summary:
In a reliable study comparable to OECD TG 401, 6 - 16 male Wistar rats were gavaged with formalin or paraformaldehyde solution in water at concentrations of 2 or 4 %.
The range of LD50 values was between 460 and 830 mg/kg bw. There is no significant difference between the paraformaldehyde and the formalin solution, nor any significant difference concerning the concentration (2 or 4 % solutions).
The mean oral LD50 value of five independent experiments in male Wistar rats is 640 mg/kg bw.
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