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Administrative data

Description of key information

Maximisation test in guinea pigs:

There is no evidence from the test results that the test item is a sensitiser in guinea pigs.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
5 March 1987 - 3 April 1987
Reliability:
1 (reliable without restriction)
Qualifier:
according to guideline
Guideline:
other: Annex V
Principles of method if other than guideline:
MAGNUSSON-KLIGMAN method
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was carried out in 1987.
Specific details on test material used for the study:
The test materal is a clear liquid and was stored in the dark under ambient conditions.
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: less than one year old
- Weight at study initiation: 300-350 g
- Housing: aluminium cage with a grid floor beneath which was a peat moss filled tray
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 52%
- Photoperiod (hrs dark / hrs light): 12 h light/dark cycle
Route:
intradermal
Vehicle:
other: distilled water
Concentration / amount:
10% v/v in distilled water
Day(s)/duration:
7 days
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% of the test item as supplied
Day(s)/duration:
14 days
Adequacy of induction:
not specified
No.:
#1
Route:
other: topical application
Vehicle:
other: distilled water
Concentration / amount:
50% of the test item
Day(s)/duration:
1 day
Adequacy of challenge:
not specified
No. of animals per dose:
test group: 20
control group: 10
dose ranging: 2
Details on study design:
RANGE FINDING TESTS:
- Injections: 50%, 25%, 10% and 5% v/v in distilled water
- Topical application: 100% as supplied, 50%, 25% and 10% v/v in distilled water

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal induction and topical induction)
- Test groups: 10% v/v of the test item in distilled water (intradermal induction) and 100% of the test item (topical induction)
- Control group: distilled water
- Site: scapular region
- Duration: 7 days

B. CHALLENGE EXPOSURE
- Day(s) of challenge: 3
- Exposure period: 48 h
- Test groups: 50% of the test item in distilled water
- Control group: distilled water
- Site: flank
- Evaluation (hr after challenge): 24h
Challenge controls:
The control group guinea pigs for each material were similarly treated but with the relevant vehicle replacing the test material.
Twenty four hours after patch removal the treated sites of both test and control groups were assessed for irritation.
Positive control substance(s):
yes
Remarks:
2,4-dinitro-chlorobenzene (DNCB)
Positive control results:
All of the test group and none of the control group showed positive responses at challenge indicating that DNCB is an extreme sensitiser in guinea piges.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50% of the test item in distilled water
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No clinical signs , except skin reactions induced by treatment, were noted at anytime during the study .
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No clinical signs, except skin reactions induced by treatment, were noted at any time duri ng the study.
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
0.1% in propylene glycol
No. with + reactions:
10
Total no. in group:
10
Clinical observations:
No clinical signs, except skin reactions induced by treatment, were noted at any time duri ng the study.
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
There is no evidence from the test results that the test item is a sensitiser in guinea pigs.
Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification