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Toxicological information

Acute Toxicity: dermal

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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:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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 study, but method used is similar to OECD TG 402.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 3-Methylbutyraldehyde
- No further information on test substance

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.5 - 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: no data
- Type of wrap if used: impervious plastic film
- Restraining of animals: animals are immobilized during the 24 h exposure period

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 individual doses are not specified
Duration of exposure:
24 hours
Doses:
no individual doses specified
No. of animals per sex per dose:
4 male rabbits per dose
Control animals:
no
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:
2 534 mg/kg bw
Remarks on result:
other: ± 1.96 standard deviations (1546 - 4128 mg/kg bw ); values are converted from mL/kg bw as reported by authors.

Any other information on results incl. tables

The acute dermal LD50 was reported as 3.18 mL/kg bw (1.94 - 5.18 mL/kg bw). The figures in parentheses show the limits of ± 1.96 standard deviations. Using a density of 0.7969 g/mL (Sect. 4.4), the LD50 calculates to 2534 mg/kg bw (1546 - 4128 mg/kg bw).

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 was 2534 mg/kg bw in male rabbits. No classifcation required according to EU legislation.
Executive summary:

The acute dermal toxicity of isovaleraldehyde (3 -methylbutyraldehyde) 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. Individual data on mortality, weight development, clinical signs, and gross necropsy findings are not reported. From mortality data, the LD50 and a range of ± 1.96 SD was calculated according to the method of Thomson (1947).

 

The acute dermal LD50 for isovaleraldehyde was determined to be 2534 mg/kg bw in rabbits (Carpenter, 1974).

 

Overall, the study was conducted similar to OECD test guideline 402 with some restrictions (only 4 animals per group, occlusive wrapping, limited reporting). The deviations from the test guideline are considered not to invalidate the result. It is rather estimated that the value determined is close-by a result from a test in compliance with the test guideline and will be located within its range of uncertainty.