Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
- 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 substance name:
- Formaldehyde
- EC Number:
- 200-001-8
- EC Name:
- Formaldehyde
- Cas Number:
- 50-00-0
- Molecular formula:
- C H2 O
- IUPAC Name:
- formaldehyde
- Test material form:
- liquid
Constituent 1
- 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 or test system 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
