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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Study period:
1977
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Pre-GLP study following a method equivalent to a recognised guideline at a limit dose, with some deviations not expected to affect the reliability of the study. Guideline study performed under GLP. The source and target substances must have an aldehyde group at the 1-carbon position and either a terminal (10-position) or an internal alkene (9-position or 8-position; with the terminal alkyl group no larger than an ethyl group and/or should not multiply substituted). The substance alkyl chain length of the substance should be more than 6 carbons in length and less than 14 carbons in length and fulfil the mono-alkene definition. The substance should not have any branched akyl groups or side chains. The target and source share common structural elements in the same relative positions. The source and target have very similar physico-chemical properties and thus have similar expected toxicokinetic behaviour. The substances have similar in silico chemical reactivity predictions. This is observed within available in vivo toxicology testing where low level local and systemic toxicity is demonstrated and comparable between target and source. The substances therefore demonstrate chemical similarity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report Date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
Limit dose of 5000mg/kg bw applied single dose; gross pathology completed.
Principles of method if other than guideline:
The principles of the method were in accordance with the US 16 CFR 1500.3 definitions.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Physical state: liquid

Test animals

Species:
rabbit
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Type of wrap if used: Not reported.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg
Duration of exposure:
24h
Doses:
5000 mg/kg
No. of animals per sex per dose:
Not reported
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Dermal reactions appear to be scored at 24 hours by the Draize scoring system. The rabbits were observed daily for 14 days for signs of toxicity, pharmacological effects and mortality. Body weights were recorded pretest and in survivors at 14 days.
- Necropsy of survivors performed: Yes.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortalities at the 5000 mg/kg bw limit dose.
Clinical signs:
None reported. No regrowth of hair at application site during the course of the 14 day observation period.
Body weight:
Not reported.
Gross pathology:
White thin walled areas of intestines in 2/10 rabbits; white area in outer surface of liver in 2/10 rabbits. White nodules in liver 1/10 rabbits.
Other findings:
Redness: 2/10 rabbits = mild redness (Score = 1) ; 6/10 rabbits = moderate skin irritation (score = 3) ; 1/10 rabbits severe (score = 4)
Edema: 10/10 rabbits = moderate (score = 3)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Under the conditions of this study the LD50 was determined to be > 5000 mg/kg and so the test material is not considerd to be toxic to rabbits via the dermal route. The substance did produced positive local irritation responses.
Executive summary:

The pre-GLP study was performed following a method similar to OECD 402 to assess the dermal toxicity of the test material to the rabbit. The test substance was evaluated in 10 rabbits. A dose of 5000 mg/kg test substance (undiluted), was applied for 24 hours. Skin observations were made 24 hours after patch removal and then daily for 14 days for signs of toxicity, pharmacological effects and mortality. No mortalities were observed. Very slight to well defined erythema and moderate edema were noted at 24 hours in all animals. Under the conditions of this study the LD50 is considered to be greater than 5000 mg/kg.