Glycine, N-coco acyl derivs., sodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1997

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:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye 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: Cool, dark place

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

not further specified

Test system

Vehicle:

water

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

0.1 mL of a 5% (w/w) solution

Duration of treatment / exposure:

single application / not rinsed

Observation period (in vivo):

up to 1 week

Number of animals or in vitro replicates:

6 per group

Details on study design:

Prior to application, both eyes of each rabbit were macroscopically examined to select healthy rabbits with eyes that were free from disease and injury in the cornea, iris and conjunctivae. The animals were then assigned to 3 groups: vehicle control (distilled water for injection), test item (5% solution) and positive control (5% SLS solution). On the day of application, each rabbit was restricted using an animal holder, and 0.1 mL of the test solution was applied using a disposable syringe to the right eye by pulling the lower eyelid into a cup-shape. Both eyelids were held together for two to three seconds following application. The left eye was designated the non-treatment control. The cornea, iris, conjunctivae and discharge were evaluated using the Draize scale 24, 48, 72 and 96 hours, and one week following application.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

24 h

Score:

41.3

Remarks on result:

probability of mild irritation

Results 2

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

7 d

Score:

1

Remarks on result:

probability of mild irritation

Applicant's summary and conclusion

Interpretation of results:

Category 2B (mildly irritating to eyes) based on GHS criteria

Conclusions:

Based on the results of this study it was assessed that a 5% w/w solution of the test item was mildly irritating to rabbit eyes.

Executive summary:

In a primary eye irritation study with rabbits, the test item was evaluated using the Draize scale and classified using the Kay and Calandra classification criteria. Slight to mild opacity ranging from less than a quarter to the whole of the cornea, congestion in the iris, mild to moderate redness of the conjunctivae, slight to definite swelling, and mild to severe discharge were observed 24 hours following administration of a 5% (w/w) solution. The irritations subsided with time, and the only irritation that was observed one week following administration was mild redness of the conjunctivae, which was observed in three cases. Based on the results of this study it was assessed that a 5% (w/w) solution of the test item was mildly irritating to rabbit eyes.