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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:
weight of evidence
Study period:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Cross-reference
Reason / purpose for cross-reference:
read-across source
Reference
Endpoint:
skin sensitisation, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Justification for type of information:
Justification is provided in the separate statement.
Reason / purpose for cross-reference:
assessment report
Reason / purpose for cross-reference:
assessment report
Interpretation of results:
GHS criteria not met
Conclusions:
The skin sensitization property of the registration substance sodium N-lauroyl glutamate is derived based on the read-across to Sodium N-cocoyl glutamate and Sodium N-cocoyl glycinate. No skin isensitizing property can be reliably derived.
Executive summary:

The skin sensitisation property of the registration substance, sodium N-lauroyl glutamate, is derived based on the read-across to sodium N-cocoyl glutamate and sodium N-cocoyl glycinate.

The registration substance and the read-across sources are amides of fatty acids and amino acids and can be characterized as "N-fatty acyl amino acids", of which endogeous occurence and metabolism are known. Based on the comparable chemical structure, comparable phys-chem data and expected comparable metabolism, these compound are likely exhibit comparable toxicity profiles.

Sodium N-cocoyl glutamate was investigated for its skin sensitization property according to the OECD 406 (Buehler method). 0.5 ml of the test material wasoccusively applied to the clipped skin of guinea pigs for 6 hours as induction and challenge treatment. None of the twenty treated animals responded. Sodium N-cocoyl glutamate is not skin sensitizing.

Sodium N-cocoyl glycinate was investigated for its skin sensitization property according to the OECD 406 (M&K). As for induction, ten male guinea pigs were treated intradermally at concentration of 5% in water and one week later epidermally at concentration of 50 % in water. Five control animals were treated with vehicle only. Two weeks after the epidermal induction, all animals were epidermally challenged at concentration of 5%. None of the animals responded. Sodium N-cocoyl glycinate is not skin sensitizing.

Likewise, the registration substance, sodium N-lauroyl glutamate is considered as not skin sensitizing.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1994

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
adopted May 12th 1981; updated July 17th, 1992
GLP compliance:
yes
Type of study:
Buehler test
Justification for non-LLNA method:
The study was performed prior to the establishment of LLNA.

Test material

Constituent 1
Chemical structure
Reference substance name:
L-Glutamic acid, N-coco acyl derivs., disodium salts
EC Number:
269-085-1
EC Name:
L-Glutamic acid, N-coco acyl derivs., disodium salts
Cas Number:
68187-30-4
Molecular formula:
Not applicable (UVCB substance)
IUPAC Name:
Disodium (2S)-2-aminopentanedioate
Test material form:
liquid
Details on test material:
22% active in water
Specific details on test material used for the study:
purity given in the report: 22% in water
pH in water: 5.8 (10g/l)

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
100% / 0.5 ml
Day(s)/duration:
6 h
Challenge
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Remarks:
The challenge treatment was performed 14 days after the induction treatment.
Concentration / amount:
100% / 0.5 ml
Day(s)/duration:
6 h
No. of animals per dose:
6 used for determination of non-irritating concentration
10 used for control
20 used for test material treatment
Details on study design:
Doses tested for the determination of non-irritating concentration: 100% test material, 50% test material in water, 10% test material; 0.5 ml was applied to skin usiing 2 x 2 cm patch; occlusive for 6 hours; irritation score reading at 24hours after removal of patch.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
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 effect
Remarks on result:
no indication of skin sensitisation
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
100%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no effect
Remarks on result:
no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Sodium N-cocoyl glutamate was investigated for its skin isensitization property according to the Guideline OECD 406 (Buehler method). It is not skin sensitizing.
Executive summary:

Sodium N-cocoyl glutamate was investigated for its skin sensitization property according to the OECD 406 (Buehler method). 0.5 ml of the test material wasoccusively applied to the clipped skin of guinea pigs for 6 hours as induction and challenge treatment. None of the twenty treated animals responded. Sodium N-cocoyl glutamate is not skin sensitizing.