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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified
Details on test animals and environmental conditions:
After an acclimatisation period of at least five days, each animal was selected at random and given a unique number. The animals were housed singly or in pairsin cages furnished with woodflakes. Free access to mains tap ater and food was allowed. The dieat, drinking water and bedding were routinely analysed. The temp. and relative humidity were set to achieve limits to 17-23 deg.C and 30-70% respectively. Rate of air exhange: at least 15 changes/our.Lightening-controlled.Environmental enrichment items were provided.
Vehicle:
arachis oil
Concentration / amount:
The concentratoins of test material to be used at each stage of the main study were determined by "sighing tests" in which groups of guinea pigs were treated with various concentrations of test material.
Selectoin of Cencentratoin for Intradermal Induction:
Intradermal injections (0.1 ml/injectoin site) were made on the clopped shoulder of one guinea pig, using a concentratoin of 5% v/v in arachis oil BP. The highest concentration that caused only mild to moderate skin irritation, and which was well tolerated systemically, was selected for the intradermal induction stage of mail study.

Selection of Concentratoin for Topical Induction:
Vehicle:
arachis oil
Concentration / amount:
The concentratoins of test material to be used at each stage of the main study were determined by "sighing tests" in which groups of guinea pigs were treated with various concentrations of test material.
Selectoin of Cencentratoin for Intradermal Induction:
Intradermal injections (0.1 ml/injectoin site) were made on the clopped shoulder of one guinea pig, using a concentratoin of 5% v/v in arachis oil BP. The highest concentration that caused only mild to moderate skin irritation, and which was well tolerated systemically, was selected for the intradermal induction stage of mail study.

Selection of Concentratoin for Topical Induction:
No. of animals per dose:
A group of fifteen guinea pigs was used for the main stjudy, ten tes and five control.
Details on study design:
The degree of erythema at the injection sites was ssessed appr. 24,48,72 hours and 7 days after injection. The degree of oedema was not evaluated. Any evidence of systemic toxicity was also recorded.
Challenge controls:
The undiluted test material and three preparatoins of the test material (75%, 50% and 25% v/v in arachis oil BP) were applied to the clipped flanks of two guinea pigs under occlusive dressings for an exposure period of 24 hours. These guinea pigs did no form part of the main study but had been treated identically to the control animals of the main study, up tpo Day 14. The degree of erythema and oedema was evaluated app 1,24 and 48 hours after dressing removal. The highest non-irritant concentration of the test material and one lower concentration were selected for the topical challenge stage of the main study.
Reading:
other: 2l readings and rechallenge
Dose level:
25%, 50% , 75%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:
Conclusions:
The test material produced a 0% (0/10) sensitization rate and was classified as a Non-Sensitizer to guinea pig skin under sonditions of the test
This material did not meet the criteria for classification as a sensitizer according to EU labelling regulations Commission Directive 2001/59/EC. No symbol and risk phrase are required.
Executive summary:

The study was performed to assess the contact sensitisation potential of the test material in the albino quinea pig, according to:

OECD Guidelines for the Testing of Chemicals No. 406 'Skin Sensitisation" (adopted 17 July 1992)

Commission Directvie 96/54/EC Method B6 Acute Toxicity (Skin Sensitisation)

method: Ten test and five control animals were used for the study. Two phases were involved in the main study; an induction of a responce by intradermal injection and topical applicatoin and a topical challenge of that responce.

Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as:

Intradermal Induction: 5% v/v in arachis oil BP

Topical Induction: 50% v/v in arachis oil BP

Topical Challenge: 75% and 50% v/v in arahis oil BP

A topical rechallenge was performed at concentrations of 50% and 25% v/v in arachis oil BP.

Conclusion: Under the conditions of the test, the test material produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to quinea pig skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
Under the conditions of the test, the test material produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin.

Justification for selection of skin sensitisation endpoint:
Availability of Klimish 1 study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The test material did not meet the criteria for classificatoin as a sensitiser according to the EU regulation.