sodium/triethanolamine- 6-(2,5-dioxo-3-C12-18-alkenyl(even and odd, branched, unsaturated)-pyrrolidin-1-yl)hexanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1993

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study; well-performed and well-documented; the test material contained the registration substance by 40%.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

1993

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:

sodium/triethanolamine- 6-(2,5-dioxo-3-C12-18-alkenyl(even and odd, branched, unsaturated)-pyrrolidin-1-yl)hexanoate

EC Number:

800-766-3

Cas Number:

1424148-97-9

Molecular formula:

C22H36NO4.1/2Na.1/2C6H16NO3 - C28H48NO4.1/2Na.1/2C6H16NO3

IUPAC Name:

sodium/triethanolamine- 6-(2,5-dioxo-3-C12-18-alkenyl(even and odd, branched, unsaturated)-pyrrolidin-1-yl)hexanoate

Test material form:

gas under pressure: refrigerated liquefied gas

Details on test material:

The test meterial contained the registration substanceby ca. 40%. The remaining components were teak oil, oleyl alcohol, polypropylen, and water.

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Duration of treatment / exposure:

Single application

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

3

Details on study design:

About 24 hours before the start of the study the test eyes of all animals were examined under UV light for corneal lesions after instillation of one drop of a 0.01% fluorescein-sodium solution. Only animals without ocular abnormalities were used for the study.
0.1 ml of the test substance was applied once to the conjuctival sac of the left eye of 3 rabbits. The untreated eyes served in each case as a control.
24 hours after application and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with flourescein-sodium solution took place, the treated eyes were washed out thoroughly with physiological saline at approx. 37°C.
The eyes were examined 1, 24, 48 and 72 hours after applicaiton of the test substance. At 24 and 72 hours as well as after 7 days, the eyes were also examined for corneal leions under UV light after instillation of one drop of 0.01% fluorescein-sodium solution. Lesions in cornea, iris or conjuctivae were graded numerically. All other changes or toxic effects were recorded. Since effects were still present in the eyes of two animals after 72 hours, further examinations were carried out after 7 days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.4

Max. score:

1

Reversibility:

fully reversible within: 3 days

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.4

Max. score:

1

Reversibility:

fully reversible within: 3 days

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: The values for individual animals were 1.0, 2.7, and 2.3

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0.9

Max. score:

3

Reversibility:

fully reversible within: 3 days

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The eye irritation potential was investigated according to the OECD Guideline 405. The test material contained the registration substance by 40 %.
The outcome of the study corresponded to "not irritating" for the test material according to DSD 67/548/EEC. Taking account that the corresponding acid is not an irritant to eyes and no local effect was observed in the combined repeated dose and reproductive/developmental toxicity screening (OECD 422), the registraton substance is assessed to be of "not irritating".
No classification is warranted.

Executive summary:

The eye irritation potential was investigated according to the OECD Guideline 405. The test material contained the registration substance by 40 %.

The outcome of the study corresponds to "not irritating" for the test material according to DSD 67/548/EEC, whereas further evidences were considered to be necessary, because obtained scores for conjunctiva redness were near to the borderline to "irritating".

Further evidences included:

- the scores obtained for cornea, iris and chemosis were clearly indicative of "not irritating",

- the effects were fully reversible within the observation period of 7 days,

- the corresponding acid was investigated at higher concentration (> 80%) and was not irritating,

- no local effect was observed in the combined repeated dose and reproductive/developmental toxicity that were performed with the registration substance.

Taking account of the all aspects, the registration substance is assessed as "not irritating" to eyes. No classification is warranted.