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Diss Factsheets

Administrative data

Description of key information

In a skin sensitization test with guinea pigs according to OECD Guideline 406, no change was observed on the skin of the animals in the test item group following challenge, while skin reactions were observed in all animals of the positive control group.

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:
1998
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
not specified
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study was performed in 1998.
Specific details on test material used for the study:
Name: Sodium cocoyl glycinate (GCS-12)
Lot No.: 970925
Description: Clear liquid
Composition: 31.5% solution
Storage: Cool, dark place
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
50 female Hartley guinea pigs were purchased from Charles River Japan, Inc. After the one-week quarantine and acclimatization period, 45 guinea pigs that showed no abnormality were selected and assigned to the vehicle control group, the test article group or the positive control group.
Route:
intradermal
Vehicle:
water
Concentration / amount:
5%
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5%
Adequacy of induction:
not specified
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
5%
Adequacy of challenge:
not specified
No. of animals per dose:
5-10
Details on study design:
Induction:
Intradermal: 5% (concentration for induction was based on the concentration in final products)
Epidermal: 5%

Challenge:
Because no primary dermal irritation was observed with respect to the test item in a preliminary study, a 5% (w/w) solution of the test item was used in the challenge.
Challenge controls:
vehicle controls
Positive control substance(s):
yes
Remarks:
2,4-dinitrochlorobenzene (DNCB)
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
none
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Dose level:
0.1%
No. with + reactions:
10
Total no. in group:
10
Remarks on result:
positive indication of skin sensitisation
Interpretation of results:
GHS criteria not met
Conclusions:
No indications for a skin sensitizing potential in guinea pigs
Executive summary:

A skin sensitization study was conducted in guinea pigs using the maximization method. Distilled water for injection was used as a vehicle control, and 2,4-dinitrochlorobenzene was used as a positive control. No change was observed on the skin of the animals in the test item group following challenge, while skin reactions were observed in all animals of the positive control group.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

In an experimental study with guinea pigs, the test item gave no indications for a possible skin sensitization. Therefore, there is no need for classification and labelling of the test item according to CLP Regulation 1272/2008/EG.