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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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- symptoms not described; no necropsy; purity of test substance not given
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxicity of formaldehyde in experimental animals
- 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:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- (symptoms not described; no necropsy)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- liquid
- Specific details on test material used for the study:
- Authors used a) formalin (37% aqueous solution stabilized with 10% methanol) or b) paraformaldehyde (polymer of formaldehyde) for preparation of solutions (presumably water used as solvent).
Purity: Special grade in a) and b)
No further details
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals and environmental conditions:
- 100-200 g body weight at initiation; 5 rats per cage; solid feed; temperature 18-20°C
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: presumably water
- Details on oral exposure:
- - Concentration in vehicle: 1) 2% and 2) 4%
- Total volume applied
Max. 33 mL/kg bw in 1) at a dose of 675 mg/kg bw
In 2) max. 28.5 mL/kg bw at a dose of 1140 mg/kg bw - Doses:
- 230, 300, 400, 520, 675, 875 mg/kg bw (2% solution)
400, 520, 675, 875, 1140 mg/kg bw (4% solution) - No. of animals per sex per dose:
- 6-16 males per dose
- Control animals:
- no
- Details on study design:
- - Postexposure period:
1 week, but surviving rats lived until the experiments were finished (3 experiments performed in at least 3 weeks) indicating only early deaths.
- Examinations
Only mortality data given - Statistics:
- Method of determination of LD50: Litchfield method
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% formalin
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 832 mg/kg bw
- 95% CL:
- 617 - 965
- Remarks on result:
- other: 4% formalin
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 550 mg/kg bw
- 95% CL:
- 420 - 715
- Remarks on result:
- other: 2% paraformaldehyde
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 710 mg/kg bw
- 95% CL:
- 550 - 910
- Remarks on result:
- other: 2% paraformaldehyde
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 640 mg/kg bw
- 95% CL:
- 551 - 742
- Remarks on result:
- other: 4% paraformaldehyde
- Mortality:
- Rats died in most cases within 24 h after application (no further details).
- Clinical signs:
- No data
- Body weight:
- 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:
- The mean oral LD50 value of five independent experiments in male Wistar rats is 640 mg/kg bw.
- Executive summary:
The study is comparable to OECD 401 with accepatable restrictions (symptoms not described; no necropsy; purity of test substance not given).
Male Wistar rats (n= 6 -16) 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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