Registration Dossier
Registration Dossier
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EC number: 203-532-3 | CAS number: 107-92-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions (only 4 animals per group, occlusive wrapping, limited reporting)
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 954
- Report date:
- 1954
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- : only 4 animals per group, occlusive wrapping, limited reporting
- Principles of method if other than guideline:
- Pre-guideline test, but method similar to OECD TG 402
- GLP compliance:
- no
- Remarks:
- pre-GLP study
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Butyric acid
- EC Number:
- 203-532-3
- EC Name:
- Butyric acid
- Cas Number:
- 107-92-6
- Molecular formula:
- C4H8O2
- IUPAC Name:
- butyric acid
- Details on test material:
- - Name of test material (as cited in study report): butyric acid
- no further information on test substance speciified
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 2.5 to 3.5 kg
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: part of the trunk
- % coverage: 1/10 of body surface
- Type of wrap if used: impervious plastic film
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): graduate doses were applied, but amount of applied substance was not specified - Duration of exposure:
- 14 hours
- Doses:
- graduated doses, individual doses not specified
- No. of animals per sex per dose:
- 4
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no data - Statistics:
- LD50 values were calculated by the method of Thompson (1947, Bacteriol. Rev. 11, 115) using the tables of Weil (1952, Biometrics 8, 249. The limits of ± 1.96 standard deviations are presented.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 6.35 mL/kg bw
- Remarks on result:
- other: corressponds to 6096 mg/kg bw (density 0.96 g/mL)
Any other information on results incl. tables
Fiducial range of LD50 value (presented as ± 1.96 S.D.) was from 3.94 - 10.28 mL/kg.
Values converted to mg/kg are (substance density = 0.96 g/mL): 3742 - 9869 mg/kg).
There is no information on local effects reported.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal LD50 for butyric acid was 6096 mg/kg bw in male rabbits requiring no classification according to EU legislation.
- Executive summary:
The acute dermal toxicity of butyric acid was determined in groups of 4 male albino New Zealand rabbits receiving graduate single doses of test substance per group. Number and quantity of individual doses are not specified. The exposure time was 24 hours followed by an observation period of 14 days. From mortality data, the LD50 and a range of ± 1.96 SD was calculated according to the method of Thomson (1947).
Overall the study was conducted similar to OECD test guideline 403 with some restrictions (only 4 animals per group, occlusive wrapping, limited reporting).
The acute dermal LD50 was 6096 mg/kg bw in rabbits (Smyth, 1954).
Based on this LD50 value, butyric acid does not require classification according to EU regulations.
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