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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1991
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1991
Report Date:
1991

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: T20-03: Magnusson-Kligman Maximization Test (Magnusson, B.,Kligman,A.M.,J.Invest.Dermat.,52,268-276,1969
Version / remarks:
1969
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The Magnusson-Kligman Maximization Test (Magnusson, B.,Kligman,A.M.,J.Invest.Dermat.,52,268-276,1969) with guinea pics was carried out or initiated before 11 October 2016. The test meets the requirements set out in Article 13(3), first subparagraph, and Article 13(4) and shall, therefore, be considered appropriate to address this standard information requirement for the skin sensitization endpoint.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Solfit
- Physical state: colorless liquid
- Lot/batch No.: 024141
- batch recieved on (date): 23 November 1990
- Storage condition of test material: in the dark under ambient conditions

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: supplied by David Hall Ltd., Darley Oaks, Newchurch, Burton-on-Trent, Staffordshire
- Age at study initiation: young adult (less than one year old)
- Weight at study initiation: 421 to 494 g
- Housing: 5 per cage in main test group and control group; 4 per cage in range finding test
- Diet (e.g. ad libitum): ad libitum (FD1 Guinea Pig Diet, supplied by Special Diets Services, 1 Stepfield, Witham, Essex, CM8 3AD)
- Water (e.g. ad libitum): ad libitum (tab water)
- Acclimation period: 7 days prior to test commencement

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 20 °C
- Humidity (%): 48 %
- Photoperiod (hrs dark / hrs light): 12 h light/12 h dark

IN-LIFE DATES: From: To:

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: Distilled water
Concentration / amount:
INDUCTION
Intradermal: 10%
dermal: 100%
CHALLENGE
dermal: 100%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: Distilled water
Concentration / amount:
INDUCTION
Intradermal: 10%
dermal: 100%
CHALLENGE
dermal: 100%
No. of animals per dose:
Test group 10 guinea pigs
Control group 10 guinea pigs
Challenge dose ranging group 4 guinea pigs
Details on study design:
1st application: Induction 10 % intracutaneous
2nd application: Induction 100 % open epicutaneous
3rd application: Challenge 100 % open epicutaneous

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
slight reaction
Remarks on result:
other: challenge
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no reaction
Remarks on result:
other: challenge
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Dose level:
vehicle with 100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no visible reaction
Remarks on result:
other: challenge
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
vehicle with 100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no visible reaction
Remarks on result:
other: challenge
Reading:
1st reading
Hours after challenge:
24
Group:
other: control with destilled water
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no visible reaction
Remarks on result:
other: challenge
Reading:
2nd reading
Hours after challenge:
48
Group:
other: control with destilled water
Dose level:
100%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no visible reaction
Remarks on result:
other: challenge

Any other information on results incl. tables

Induction: Slight irritation was noted in the test group.
Challenge: Following challenge with the test material at a concentration of 100%, none of the 10 test group showed positive reactions to this application.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Conclusions:
A well conducted, well reported guinea-pig skin sensitization test (Magnusson-Kligman method) reported that a 10% concentration of the test material in water induced no sensitization response when challenged with 100% of the test substance. Appropriate concurrent negative compliance controls were included.