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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study, GLP-compliance, available as unpublished report, adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
observation after 48 h is missing
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): ETHYL THIURAD
- Molecular formula (if other than submission substance):
- Molecular weight (if other than submission substance):
- Smiles notation (if other than submission substance):
- InChl (if other than submission substance):
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type:
- Physical state: off-white powder
- Purity: 98.6%
- Impurities (identity and concentrations):
- Composition of test material, percentage of components:
- Isomers composition:
- Purity test date:
- Lot/batch No.: 5394
- Expiration date of the lot/batch: :
- Stability under test conditions:
- Storage condition of test material:
- Other:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Isaac’s Farm, Litchfield, Illinois
- Age at study initiation: young adult
- Weight at study initiation: 2.26-2.70 kilograms
- Housing: individually housed
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least five days

Test system

Type of coverage:
occlusive
Preparation of test site:
abraded
Vehicle:
physiological saline
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ± .003 grams
Duration of treatment / exposure:
24 hours
Observation period:
After one hour, 24 hours, 72 hours and 7 days of exposure
Number of animals:
6 animals (3 males and 3 females)
Details on study design:
TEST SITE
- Area of exposure: dorsal surface
- Type of wrap if used: an occlusive wrap of latex rubber

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the excess material was wiped from the treated sites of the animals
- Time after start of exposure: 24 hours

SCORING SYSTEM: Dermal irritation was scored by the method of Draize (1944)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0.96
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Other effects:
All five animals that were observed for signs of irritation on the seventh day after exposure had epidermal desquamation on one or both abraded sites. However, since all erythema and oedema had subsided, and desquamation is not considered to represent primary irritation by the method of Draize, no further observations for signs of irritation were conducted.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information