Glycine, N-coco acyl derivs., sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Glycine, N-coco acyl derivs., sodium salts

EC Number:

291-350-5

EC Name:

Glycine, N-coco acyl derivs., sodium salts

Cas Number:

90387-74-9

Molecular formula:

Molecular formula for this UVCB is not available.

IUPAC Name:

Glycine, N-coco acyl derivs., sodium salts

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 condition: Cool, dark place

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

not further specified

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

TEST MATERIAL
0.3 mL of a 5% (w/w) solution

VEHICLE
0.3 mL of distilled water for injection

POSITIVE CONTROL
0.3 mL of a 5% (w/w) SLS solution

Duration of treatment / exposure:

24 h

Observation period:

up to 1 week

Number of animals:

6 per group

Details on study design:

On the day before application, the hair on flank of the rabbits was shorn using electric hair clippers. Six healthy rabbits that did not have uneven hair growth were selected for the study.
On the day of application, 0.3 mL of distilled water for injection, 5% (w/w) test item or 5% (w/w) SLS solution was applied to the cotton area of a patch (2.5 cm in diameter) using a disposable syringe. The patch was then applied to the shorn area. Following application, the rabbits were fitted with a vest for 24 hours (closed patch testing). The vest and the patch were removed 24 hours following application. Thirty minutes later, the levels of erythema and edema at the test site were evaluated using the Draize scale.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

7 d

Score:

1.4

Reversibility:

fully reversible within: 7 d

Remarks on result:

no indication of irritation

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on a primary dermal irritation index (PDII) of 1.4 it can be concluded that the test item (5% w/w solution) will not be irritant to the skin of rabbits.

Executive summary:

A primary dermal irritation study with the test item was conducted in rabbits using the Draize method (24 -hour occlusive patch). Based on a primary dermal irritation index (PDII) of 1.4, a significant skin irritation potential of the test item (5% w/w solution) is not to be expected.