L-Alanine, N-coco acyl derivs., sodium salts

Skin sensitisation

Administrative data

Endpoint:

skin sensitisation: in vivo (non-LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2006

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2006

Report date:

2006

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 406 (Skin Sensitisation)

Version / remarks:

07-1992

Deviations:

no

GLP compliance:

yes

Type of study:

guinea pig maximisation test

Justification for non-LLNA method:

Study was performed in 2006

Test material

Test material information

Constituent 1

Reference substance name:

L-Alanine, N-coco acyl derivs., sodium salts

EC Number:

290-478-9

EC Name:

L-Alanine, N-coco acyl derivs., sodium salts

Cas Number:

90170-45-9

Molecular formula:

RHNNaO3

IUPAC Name:

L-Alanine, N-coco acyl derivs., sodium salts

Test material form:

solid

Specific details on test material used for the study:

Name: Sodium Cocoyl-L-Alaninate (ACS-12)
Lot No.: 601011
Description: liquid
Purity: 30.1 % (as active ingredient)

In vivo test system

Test animals

Species:

guinea pig

Strain:

Dunkin-Hartley

Sex:

female

Details on test animals and environmental conditions:

Original study in Japanese

Study design: in vivo (non-LLNA)

Induction

Induction 1

Route:

intradermal

Vehicle:

physiological saline

Concentration / amount:

0.1 % (w/w)

Day(s)/duration:

day 1

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

Induction 2

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

10% (w/w)

Day(s)/duration:

day 8 (over 48 hours)

Adequacy of induction:

highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically

Challenge

Route:

epicutaneous, occlusive

Vehicle:

water

Concentration / amount:

2.5 and 0.5 % (w/w)

Day(s)/duration:

day 22 (over 24 hours)

Adequacy of challenge:

highest non-irritant concentration

No. of animals per dose:

Group 1 (vehicle controls): 5 f
Group 2 (test item): 10 f

Details on study design:

During the study the guinea pigs were examined for local skin reactions and general condition.

Positive control substance(s):

yes

Remarks:

mercaptobenzothiazole

Results and discussion

Positive control results:

all tested animals reacted positive as expected

In vivo (non-LLNA)

Results

Key result

Reading:

other: 1st and 2nd reading (24 and 48 hrs after challenge)

Hours after challenge:

48

Group:

test chemical

Dose level:

0.5 and 2.5 % (w/w)

No. with + reactions:

0

Total no. in group:

10

Clinical observations:

no

Remarks on result:

no indication of skin sensitisation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the given experimental conditions, the test item showed no positive responders and has not to be classified as a sensitizer.

Executive summary:

The test item was evaluated for skin sensitizing properties in a GLP study performed according to OECD GL 406. 5 female guinea pigs in the negative control group treated with the vehicles and 10 females in the test material group were investigated. After challenge no positive reactions in the test material treated skin sites at both readings were seen. Under the given experimental conditions, the test item showed no positive responders and has not to be classified as a sensitizer.