Amines, N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, N-(hydroxyethyl) derivs.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Study period:

29-09-1971 - 29-11-1971

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: No data on identity of the substance; Reference is made to guidance of Draize, but no information is given. No information on observations or gradings.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Draize

Principles of method if other than guideline:

Washing after already 1 minute exposure in 4 animals iso 24 hours.
8 animals were tested all at once iso sequential testing.

GLP compliance:

not specified

Remarks:

pre-GLP

Test material

Test material information

Constituent 1

Reference substance name:

Amines, N-(C16-18 (even numbered) and C18-unsatd. alkyl) trimethylenedi-, ethoxylated(NLP)

EC Number:

800-029-6

Cas Number:

1290049-56-7

Molecular formula:

Not applicable

IUPAC Name:

Amines, N-(C16-18 (even numbered) and C18-unsatd. alkyl) trimethylenedi-, ethoxylated(NLP)

Test material form:

other: liquid solution

Details on test material:

Berol TL 455 was obtained from MoDoKemie AB Stenungsund on 29 September 1971.
Test solution was 20% testsubstance ("WAS = Waschaktieve Substanz") in ethanol/water.

Test animals / tissue source

Species:

rabbit

Strain:

not specified

Details on test animals or tissues and environmental conditions:

No data on animal origin, husbandry, age, size

Test system

Vehicle:

water

Controls:

not required

Amount / concentration applied:

0.1 ml of a 5% solution of the substance received (20% strength), therefore 1% strength.

Duration of treatment / exposure:

1 minute

Observation period (in vivo):

Not given

Number of animals or in vitro replicates:

8 of which 4 animals had their exposed eye rinsed after 1 minute.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, with lukewarm physiological NaCl solution directly after exposure.
- Time after start of exposure: 1 min

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

other: all animals

Time point:

other: unknown

Irritant / corrosive response data:

No reactions on the eye (Augenschleimhaut) were observed. No immunoresponses.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Classification according to GHS is not possible, as the study does not allow this on the basis of results presented. Based on the findings, this 5% solution of the test substance does not give indications for eye irritation.

Executive summary:

The product was tested for eye irritation in rabbit eyes. The method was performed according to Draize. 8 rabbits were exposed to 1 ml of a 5% solution of the product. The product was applied to the right eye of the animal. In 4 animals the product was rinsed from the eye after 1 minute, in the other 4 animals the product was left. None of the animals showed reactions of the eye or relating membranes. Also, no immunoresponses were noted.