β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed to valid methods

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 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts

EC Number:

290-476-8

EC Name:

β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts

Cas Number:

90170-43-7

IUPAC Name:

β-Alanine, N-(2-carboxyethyl)-, N-coco alkyl derivs., disodium salts

Test material form:

other: Solution

Details on test material:

Trade name Lakeland AMA used. This is an approximate 40% solution in water in the form used for supply.
In view of irritation, the study is considered valid and repeating the study is not appropriate.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

The animals were in the weight range of 2.5 to 3.0 kg and approximately 11 to 13 weeks of age, prior to treatment (Day 1).
All rabbits were acclimatised to the experimental environment.
The rabbits were selected without conscious bias for the study.
They were housed individually in plastic cages with perforated floors

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

One animal was treated in advance of the others, to ensure that if a severe response was produced, no further animals would be exposed (pilot animal see Table 1).
Approximately 0.1 ml of the test substance was placed into the lower everted lid of one eye of each animal.
The eyelids were then gently held together for one second before releasing. The other eye remained untreated.

Observation period (in vivo):

Examination of the eyes was made after 1 hour and 1, 2, 3 (equivalent to 24, 48 and 72 hours after
instillation), 4, 7 and 14 days after instillation. Observation of the eyes was aided by the use of a handheld light.

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: Days 1- 3

Score:

ca. 2.5

Max. score:

4

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Positive response

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: Days 1 - 3

Score:

ca. 0.3

Max. score:

1

Reversibility:

fully reversible within: 4 days

Results 3

Irritation parameter:

conjunctivae score

Remarks:

Redness

Basis:

mean

Time point:

other: Days 1 - 3

Score:

ca. 2.3

Max. score:

3

Reversibility:

fully reversible within: 14 days

Remarks on result:

other: Positive response

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: Days 1 - 3

Score:

ca. 1.9

Max. score:

3

Reversibility:

fully reversible within: 14 days

Other effects:

Animals otherwise appeared healthy

Applicant's summary and conclusion

Interpretation of results:

irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Due to corneal and conjunctival effects, using a mean of three animals at 24, 48 and 72 hour timepoints, the substance should be classified.
Proposed classification Eye Irrit 2

Executive summary:

The material tested was in the form as supplied at approximately 40%. As this gave a positive effect, further in-vivo testing at higher concentrations is not permitted for animal welfare reasons.

For in-vitro testing, solid materials need to be diluted to form fluid liquids and as this would mean testing solutions of 40% or lower, performing an in-vitro assay on this same concentration is not considered necessary.