oils, palm, propoxylated

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09 August 2002 - 30 August 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

24 February 1987

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,2',2''-Nitrilotriethanol, propoxylated

EC Number:

500-094-8

EC Name:

2,2',2''-Nitrilotriethanol, propoxylated

Molecular formula:

C6H15O3N(C3H6O)n ; n >1 and n< 6.5

IUPAC Name:

2,2',2''-Nitrilotriethanol, propoxylated

Details on test material:

TS: 2, 2', 2''-Nitrilotriethanol, propoxylated, (Mm = approx. 340 g/mol)

Lot No: 20104

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Untreated eye was used as control

Amount / concentration applied:

undiluted
Amount applied: 0.1 ml

Observation period (in vivo):

1, 24, 48 and 72 hour

Number of animals or in vitro replicates:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible within: 24 hrs

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

No corneal or iridial effects were noted during the study. Moderate conjunctival irritation was noted in all treated eyes one hour after treatment with minimal conjunctival irritation noted in all treated eyes at the 24h-observation. Treated eyes appeared normal at the 48-hour and 72-hour observation.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The substance produced a maximum group mean score of 10.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system. The substance did not meet the criteria for classification according to EU labelling.

Executive summary:

The irritatncy potential of the substance to the eye of New Zealand White rabbit was assessed according to the OECD TG 405 (Acute Eye Irritation/Corrosion). In the absence of skin irritation data a Rabbit Enucleated Eye Test was performed prior to the in vivo study and the results from this study indicated that the substance qwas unlikely to cause severe ocular irritancy. A single application of the substance to the unwashed eye of three rabbits produced moderate conjunctival irritation. All treated eyes appeared normal at the 48-hour observation. the substance produced a maximum group mean score of 10.0 and was classified as a minimal irritant (Class 3 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.