Reaction products of 3-methylbutanal and 3-methylbut-3-en-1-ol, distillation overheads, acid-treated

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:

1974

Report date:

1974

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 study, but method used is similar to OECD TG 402.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Isovaleraldehyde

EC Number:

209-691-5

EC Name:

Isovaleraldehyde

Cas Number:

590-86-3

Molecular formula:

C5H10O

IUPAC Name:

3-methylbutanal

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 or test system 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.