Reaction mass of sodium hydrogen N,N-dibutyl-10-(sulphonatooxy)octadecanamidate and sodium sulphooctadecanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1977

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: no GLP; short report, few details on test substance as well as on results

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

Observation ended at 72 hours after start of exposure

Principles of method if other than guideline:

Eyes were washed using physiologic salt solution after 24 hours.
Eyes were treated with 0.01 % fluorescine sodium in water before observations at 48 and 72 hours.

GLP compliance:

no

Remarks:

pre-dates GLP

Test material

Test material information

Constituent 1

Reference substance name:

N,N-dibutyloleamide and oleic acid, sulphated, sodium salts

EC Number:

915-926-9

Molecular formula:

C18H34Na2O6S + C26H52NNaO5S

IUPAC Name:

N,N-dibutyloleamide and oleic acid, sulphated, sodium salts

Test material form:

liquid

Details on test material:

The water content of the actual test item was 57.6% (w/w); the water content of the REACH registration substance was analytically determined to be 3.8% (w/w).

Test animals / tissue source

Species:

rabbit

Strain:

Himalayan

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

0.1 mL per eye

Duration of treatment / exposure:

Observations were recorded at 1, 7, 24, 48 and 72 hours after instillation

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Remarks:

slight turbidity

Basis:

animal: 2 out of 3 animals

Time point:

24/48/72 h

Reversibility:

not specified

Remarks on result:

other: no scores, but a narrative description given in the report

Results 2

Irritation parameter:

conjunctivae score

Remarks:

obvious swelling

Basis:

animal: all animals

Time point:

24/48/72 h

Reversibility:

not specified

Remarks on result:

other: no scores, but a narrative description given in the report

Results 3

Irritation parameter:

iris score

Basis:

animal: all animals

Time point:

24/48/72 h

Remarks on result:

other: No effects reported, no data on individual animals available

Results 4

Irritation parameter:

chemosis score

Basis:

animal: all animals

Time point:

24/48/72 h

Reversibility:

not specified

Remarks on result:

other: no scores, but a narrative description given in the report

Irritant / corrosive response data:

Two of three animals showed slight corneal opacity and all animals diffuse reddening of conjunctivae and moderate chemosis. Additionally severely increased secretions were recorded.
The material was evaluated as moderately irritant.

Other effects:

no data

Applicant's summary and conclusion

Interpretation of results:

other: moderately irritating

Conclusions:

The test material was moderately irritating to rabbit eyes instillation of 0.1 mL.

Executive summary:

Three rabbits were treated by instillation of 0.1 mL of the undiluted test material into the conjunctival sac of one eye each. Observations were recorded at 1, 7, 24, 48, and 72 hours after instillation. Eyes were washed using physiologic salt solution after 24 hours.

Eyes were treated with 0.01% fluorescine sodium in water before further observations. The test material elicited slight corneal opacity in 2 of 3 rabbits and diffuse erythema, moderate chemosis and severe discharge in all animals.