Glycerides, tallow sesqui-, hydrogenated, propoxylated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6 October 1986 - 13 October 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

May 12, 1981

Deviations:

not specified

GLP compliance:

not specified

Test material

Test material information

1

Reference substance name:

Glycerides, tallow sesqui-, hydrogenated, propoxylated

EC Number:

614-598-1

Cas Number:

68553-12-8

Molecular formula:

n/a

IUPAC Name:

Glycerides, tallow sesqui-, hydrogenated, propoxylated

Test animals / tissue source

Species:

rabbit

Strain:

other: Kieine white Russians, Chbb-SPF

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 cm3

Duration of treatment / exposure:

72 hours

Observation period (in vivo):

1, 24, 48 and 72 hours and 6 days after application.

Number of animals or in vitro replicates:

Three

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

overall irritation score

Basis:

animal: all three

Time point:

24/48/72 h

Score:

0.83

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hr

Score:

3.33

Reversibility:

fully reversible within: 24

Remarks on result:

other: mild irritation upon dosing only

Results 5

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 6

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test material was not irritating to the eyes.

Executive summary:

In an in vivo eye irritation study three rabbits were exposed to the substance by instillation of the substance into one eye. The corresponding eye of the same animal was left untreated and acted as concurrent control. The treated eyes were washed out with sodium chloride solution after 72 hours. The eyes were examined at 1, 24, 48 and 72 hours and 6 days post-exposure. The substance produced slight to mild conjunctival irritation upon dosing. At 7 days, no conjunctival irritation was observed in all animals dosed. No corneal involvement or irritis was observed during the 7 day observation period. The substance is not expected to be an eye irritant under the conditions of this study.