sodium 3-[(2,3-dicyanophenyl)thio]propane-1-sulfonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

Test phase 2013-04-03 to 2013-04-06. Report completed 2013-05-13.

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Meets the criteria for classification as reliable with restrictions according to Klimisch et al (1997). This read-across is based on the hypothesis that the Source and Target substances will have similar toxicological and ecotoxicological properties due to their close physical-chemical and structural similarities. For example, both the Source and Target substances are monoconstituents which share structural similarities and contain the same functional groups (thio ether, sulfonate, vicinal nitrile groups).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2013

Report date:

2013

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

See Confidential details on test material section

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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.

Any other information on results incl. tables

The Source substance has a comprehensive data set generated for a REACH Annex VIII registration and this along with its similarity to the Target substance are consider sufficient to consider the read-across an appropriate adaptation to the standard information requirements of Annex VII of the REACH regulation for the Target substance in accordance with the provisions of Annex XI, 1.5 of the REACH regulation. Please see the attached document in the Background Material section for further details on the justification of the read across approach.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The source 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 Source substance has a comprehensive data set generated for a REACH Annex VIII registration and this along with its similarity to the Target substance are consider sufficient to consider the read-across an appropriate adaptation to the standard information requirements of Annex VII of the REACH regulation for the Target substance in accordance with the provisions of Annex XI, 1.5 of the REACH regulation. Please see the attached document in the Background Material section for further details on the justification of the read across approach.

The source 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 source 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 source 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 source 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.

The Source substance has a comprehensive data set generated for a REACH Annex VIII registration and this along with its similarity to the Target substance are consider sufficient to consider the read-across an appropriate adaptation to the standard information requirements of Annex VII of the REACH regulation for the Target substance in accordance with the provisions of Annex XI, 1.5 of the REACH regulation. Please see the attached document in the Background Material section for further details on the justification of the read across approach.