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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vitro / ex vivo
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. 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:
other: Acute Toxicity Dermal - OECD 402
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 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

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST SITE
- Type of wrap if used: Not reported.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 5000 mg/kg
Duration of treatment / exposure:
24h
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

In vitro

Resultsopen allclose all
Irritation / corrosion parameter:
other: erythema score
Value:
2.4
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 24h. Max. score: 4.0. Reversibility: no data. (migrated information)
Irritation / corrosion parameter:
other: edema score
Value:
3
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 24h. Max. score: 4.0. Reversibility: no data. (migrated information)

In vivo

Irritant / corrosive response data:
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:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Under the conditions of this study 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.