Amines, C12-18-alkyl, reaction products with acrylic acid, sodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1963

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

The test was conducted according to an accepted testing procedure (Draize test). However, only few data on the testing and results were given, and no details on individual scorings were provided in the document. Thus, the data are insufficient for scoring evaluation according to current criteria, and no assessment for classification purpose is feasible. Nevertheless, the data give some evidence of eye irritation. The study was performed on an analogue substance (for justification of read-across, please refer to the corresponding assessment report in Section 13).

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1963

Materials and methods

Principles of method if other than guideline:

The test conduct was based on the Draize Test (Draize et al. J Pharm and Exp Ther 82, 1944) according to the Federal Register - Code of the Federal Regulations, Part 191, Chapter I, Title 21, reprinted from Federal Register of August 12, 1961, 26 F.R. 7333.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate

EC Number:

239-032-7

EC Name:

Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate

Cas Number:

14960-06-6

IUPAC Name:

Sodium Lauriminodipropionate

Test material form:

other: liquid

Details on test material:

- Common name : Sodium lauriminodipropionate
- For more details, see below the Confidential details for test material

Specific details on test material used for the study:

The study was performed on a commercial product (aqueous solution) as the test item is manufactured and used in a liquid form.

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Test system

Vehicle:

not specified

Controls:

other: untreated contralateral eye

Amount / concentration applied:

a 5% solution of the test item was used.

Duration of treatment / exposure:

Single instillation into the conjunctival sac of the eye without washing out

Observation period (in vivo):

7 days
Reading time points: 24, 48, 72 and 96 hours, and on day 7

Number of animals or in vitro replicates:

no data reported

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

72 h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Results 3

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

72 h

Score:

0

Reversibility:

fully reversible

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

48 h

Score:

0

Reversibility:

fully reversible

Results 5

Irritation parameter:

iris score

Basis:

mean

Time point:

48 h

Score:

2.5

Reversibility:

fully reversible

Results 6

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

48 h

Score:

0.8

Reversibility:

fully reversible

Results 7

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24 h

Score:

3

Reversibility:

fully reversible within: 72 h

Results 8

Irritation parameter:

iris score

Basis:

mean

Time point:

24 h

Score:

5.8

Reversibility:

fully reversible within: 72 h

Remarks on result:

other: Unconventional scoring method

Results 9

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24 h

Score:

2.6

Reversibility:

fully reversible within: 72 h

Irritant / corrosive response data:

- Following scoring values were reported:
. Cornea: 3.0 at 24 h, 0.8 at 48 h and 0 at 72 h
. Iris: 5.8 at 24 h, 2.5 at 48 h and 0 at 72 h
. Conjunctivae: 2.6 at 24 h, 0 at 48 h and 0 at 72 h (no distinction was made between redness and chemosis)

The values reported for the iris (i.e. 5.8 and 2.5) indicate that the scoring as performed in the study was not in accordance with scoring procedure as currently needed and conducted for purpose of assessment of the eye irritation potential of the test item.
Nevertheless, since scores of 0 were reported at reading time point 72 h for each of cornea, iris and conjunctivae, full reversibility seems to be achieved at that time point.

Applicant's summary and conclusion

Interpretation of results:

other: not possible accoring to current criteria

Conclusions:

Eye reactions were noticed at 24 and 48 h, but recovery seemed to be achieved at 72 h post-instillation.

Executive summary:

A test solution containing 5% of sodium lauriminodipropionate was tested in rabbits for eye irritation according to the Draize test as described in the Federal Register - Code of the Federal Regulations, Part 191, Chapter I, Title 21, reprinted from Federal Register of August 12, 1961, 26 F.R. 7333.

- Following scoring values were reported:

. Cornea: 3.0 at 24 h, 0.8 at 48 h and 0 at 72 h.

. Iris: 5.8 at 24 h, 2.5 at 48 h and 0 at 72 h.

. Conjunctivae: 2.6 at 24 h, 0 at 48 h and 0 at 72 h (no distinction was made between redness and chemosis).

The values reported for the iris (i.e. 5.8 and 2.5) indicate that the scoring as performed in the study was not in accordance with scoring procedure as currently needed and conducted for purpose of assessment of the eye irritation potential of the test item.

Nevertheless, since scores of 0 were reported at reading time point 72 h for each of cornea, iris and conjunctivae, full reversibility seems to be achieved at that time point.