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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:
1969
Report date:
1969

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
GLP compliance:
no
Remarks:
pre-GLP study
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Valeraldehyde
EC Number:
203-784-4
EC Name:
Valeraldehyde
Cas Number:
110-62-3
Molecular formula:
C5H10O
IUPAC Name:
valeraldehyde
Details on test material:
- Name of test material (as cited in study report): Valeraldehyde
- no further information on test material

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 animals 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:
4 857 mg/kg bw
Remarks on result:
other: LD50 is originally reported in mL/kg bw

Any other information on results incl. tables

The acute dermal LD50 was reported as 6 mL/kg bw. Using a density of 0.8095 g/mL (Auer Technikum Edition 12, Auergesellschaft GmbH, Berlin, 198

), the LD50 calculates to 4857 mg/kg bw. There is no information on local effects reported.

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 4857 mg/kg bw in male rabbits. No classifcation required according to EU legislation.
Executive summary:

The acute dermal toxicity of valeraldehyde 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 valeraldehyde was determined to be 4857 mg/kg bw in rabbits (Smyth, 1969).

 

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.

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