Disodium (Z)-4-(9-octadecenylamino)-4-oxo-2(or 3)-sulphonatobutyrate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

1956

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was not performed under GLP and no scores were made, therefore the results can not be exactly quantitatively judged. However as a weight-of-evidence study, the iformation is valuable to confrim in vitro results.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1956

Report date:

1956

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

yes

Remarks:

no detailed scoring done

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Butanoic acid, 4-amino-4-oxosulfo-, N-tallow alkyl derivs., disodium salts'

IUPAC Name:

Butanoic acid, 4-amino-4-oxosulfo-, N-tallow alkyl derivs., disodium salts'

Constituent 2

Reference substance name:

68988-69-2

Cas Number:

68988-69-2

IUPAC Name:

68988-69-2

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): Aerosol 18, disodium N-(octadecyl)-sulfosuccinate
- Physical state: Aqueous solution (cream-colored paste)
- Analytical purity: 35%
- Impurities (identity and concentrations): Not provided
- Composition of test material, percentage of components: See confidential details
- Isomers composition: Not provided
- Purity test date: Not provided
- Lot/batch No.: Not provided
- Expiration date of the lot/batch: Chemically stable
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided
- Other: specific gravity : 1.16 for 35% solution

Test animals / tissue source

Species:

rabbit

Strain:

other: albino

Details on test animals or tissues and environmental conditions:

Not provided

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: left eye as control is not mentioned

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Approximately 10 mg of the product as received
- Concentration (if solution): 35% active ingredient

Duration of treatment / exposure:

The lids were held closed for about 30 seconds following introduction of the dose.

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

5

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No

SCORING SYSTEM: Not provided

TOOL USED TO ASSESS SCORE: Not provided

Results and discussion

In vivo

Irritant / corrosive response data:

There was copious lacrimation shortly after application of the dose, and a moderate degree of conjunctivitis and edema of the lids developed within four hours. A slight opalescence of the cornea was present in one case. The erythema and edema subsided during the 24 hours following the dose, and was not observed after this time. Lacrimation continued to be evident in the case of the animal noted. From the third day till the end of a total 7-day observation period, all eyes maintained a normal appearance.

Any other information on results incl. tables

No scores available

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

3.5 mg active ingredient was slightly irritating to the rabbit eye.

Executive summary:

Approximately 10 mg of the test item containing 35% active ingredient was instilled into the conjunctival sac of the right eye of each of five albino rabbits. The lids were held closed for about 30 seconds following introduction of the dose, and the eye was examined immediately thereafter and again at intervals over the next several days. There was copious lacrimation shortly after application of the dose, and a moderate degree of conjunctivitis and edema of the lids developed within four hours. A slight opalescence of the cornea was present in one case. The erythema and edema subsided during the 24 hours following the dose, and was not observed after this time. Lacrimation continued to be evident in the case of the animal noted. From the third day till the end of a total 7-day observation period, all eyes maintained a normal appearance.