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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:
key study
Study period:
Test phase 2013-04-03 to 2013-04-06. Report completed 2013-05-13.
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Meets the criteria for classification as reliable without restriction according to Klimisch et al (1997).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
lithium 3-((3,4-dicyanophenyl)thio)propane-1-sulfonate
EC Number:
700-787-7
Cas Number:
769953-18-6
Molecular formula:
C11H9N2O3S2Li
IUPAC Name:
lithium 3-((3,4-dicyanophenyl)thio)propane-1-sulfonate

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories Uk Ltd, Leicestershire, UK
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.51 and 2.74kg
- Housing: Housed individually in suspended cages
- Diet: Free access to food throughout the study
- Water: Free access to water throughout the study
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied ): 0.5g of the test material moistened with 0.5ml of distilled water
Duration of treatment / exposure:
4h
Observation period:
72h
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: back
- Type of wrap if used: Moistened test material was introduced under a 2.5cm x 2.5cm cotton gauze patch. The patch was secured with surgical tape. The trunk of each rabbit was wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material was removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 73088 Male
Time point:
other: Score at 24, 48 and 72h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
erythema score
Basis:
animal: 73089 Male
Time point:
other: Score at 24, 48 and 72h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48h
Irritation parameter:
edema score
Basis:
animal: 73088 Male
Time point:
other: Score at 24,48 and 72h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritation parameter:
edema score
Basis:
animal: 73089 Male
Time point:
other: Score at 24, 48 and 72h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24h
Irritant / corrosive response data:
Changes fully reversible within 48h.

The test material produced a primary irritation index of 0.5 and was classified as a mild irritant to rabbit skin according to the Draize classification system. No corrosive effects were recorded.
Other effects:
Both animals showed expected weight gain in body weight during the study.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a primary irritation index of 0.5 and was classified as a mild irritant to rabbit skin according to the Draize classification system. No corrosive effects were recorded.

The test material did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commision Directive 2001/59/EC for Classification and Labelling of Dangerous Substances. The results were also interpreted according to Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
Executive summary:

Introduction

This study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used was designed to be compatible with the following guidelines:

- OECD Guidelines for the Testing of Chemicals No. 404 'Acute Dermal Irritation/Corrosion' (adopted 24 April 2002)

- Method B4 Acute Toxicity (Skin Irritation) of Commission Regulation (EC) No. 440/2008.

Results and Conclusion

The test material produced a primary irritation index of 0.5 and was classified as a mild irritant to rabbit skin according to the Draize classification system. No corrosive effects were recorded.

The test material did not meet the criteria for classification as irritant or corrosive according to the EU labelling regulations Commision Directive 2001/59/EC for Classification and Labelling of Dangerous Substances. The results were also interpreted according to Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.

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