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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
Study period:
1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study conducted under OECD guidelines
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This non LLNA study was conducted at the time when LLNA study was not developed
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
Twenty-three male albino Dunkin Hartly guinea pigs were supplied by David Hall Limited, Burton-on-Trent, Staffordshire, UK.
Weight: 392-460 g; 8-12 months old.
After an acclimatisation period of at least 5 days each animal was selected at random and given a number.
The animals were housed singly or in pairs in solid-floor polypropylene cages furnished with wood flakes.
free access to food and water was allowed throughout the study.
Temp: 19-23°C and relative humidity of 47-65%.
Air exchange: 15 changes per hour.
Lighting: 12 hr light, 12 hr darkness.
Route:
intradermal
Vehicle:
arachis oil
Concentration / amount:
Intradermal induction: 1%, 5%, 10% and 25% w/v; Topical induction: 10%, 25%, 50% and 75% w/w ; Topical challenge: 10%, 25%, 50% and 75% w/w.
Route:
intradermal
Vehicle:
arachis oil
Concentration / amount:
Intradermal induction: 1%, 5%, 10% and 25% w/v; Topical induction: 10%, 25%, 50% and 75% w/w ; Topical challenge: 10%, 25%, 50% and 75% w/w.
No. of animals per dose:
Intradermal induction: A total of three guinea pigs were used, each receiving four 0.1ml injections of only one concentration of test material.
Topical induction: Two guinea pigs were treated with four preparations of the test material.
Topical challenge: Four preparations of the test material were applied to the clipped flanks of two guinea pigs.
Main study: group of 15 guinea pigs was used for the main studt, ten test and five control.
Details on study design:
See attached document on study design
Challenge controls:
Intradermal injections were administered using an identical procedure th that used for the test animals, except that the injections were:
a. Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b. arachis oil BP
c. a 50% w/v formulation of arachis oil BP in Freund's Complete Adjuvant/distilled water 1:1
Approx. 24 and 48 hr after intradermal injection the degree of erythema at the vehicle sites was evaluated.
The topical applications followed the same procedure as for the test animals except that the vehicle alone was applied to the filter paper. Skin reactions were quantified as for test animals.
Positive control substance(s):
not specified
Reading:
other: blind
Hours after challenge:
24
Group:
test group
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:
Reading:
other: blind
Hours after challenge:
48
Group:
test group
Dose level:
75%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:
Reading:
other: blind
Hours after challenge:
24
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:
Reading:
other: blind
Hours after challenge:
48
Group:
test group
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading:

Main study, Intradermal induction:

Well defined erythema was noted at the intradermal induction sites of the test group animals at the 24 hr observation with very slight to moderate to severe erythema at the 48 hr observation.

Very slight erythema was noted at the intradermal induction sites of all test group animals at the 24 hr observation and in two control group animals at the 48 hr observation.

Main study, Topical induction:

Very slight to well defined erythema was noted at the induction sites of all test group animals at the 1 -hr observation and in six test group animals at the 24 hr observation.

No skin reactions were noted at the treatment sites of control group animals at the 1 and 24 hr observations.

Main study, Topical challenge:

No skin reactions were noted at the challenge sites of the test or control group animals at the 24 or 48 hr observations.

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a 0% (0/10) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin.
Executive summary:

M&K maximisation test was conducted in albino guinea pigs using OECD guidelines 406 and method B6 of the commission directive 92/69/EEC.

Ten test and five control animals were used for the main study.

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

Intradermal induction: 10% w/v in arachis oil BP

Topical induction: 75% w/w in arachis oil BP

Topical challenge: 75% and 50% w/w in arachis oil BP

The test material produced a 0% (0/10) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:
Migrated from Short description of key information:
The test material produced a 0% (0/10) sensitisation rate and was classified as a non sensitiser to guinea pig skin. This test material did not meet the criteria for classification as a sensitiser according to EU and GHS labelling regulations.

Justification for selection of skin sensitisation endpoint:
Experimental study available

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the results of the M&K sensitisation test, the test material did not meet the criteria for classification and labelling under Annex VI of Council Directive 67/548/EEC and the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No.1272/2008.