Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
October 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance propane-1,2-diyl diacetate (CAS 623-84-7). In accordance to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test material was a colourless liquid. No additional information available in the report.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Three young adult, female, New Zealand White rabbits obtained from Ranch Rabbits, Crawley were used for the study.

At the start of the study the rabbits weighed between 4.00 and 4.45 kg and were aged between 11 and 20 weeks. They were acclimatised to the laboratory environment for at least 3 days and were examined for signs of ill health or eye defects shortly before the study started.

The animals were housed individually in grid floor cages in a single room at a temperature between 16 and 20°C and relative humidity between 60 and 69%. Fluorescent lighting was automatically controlled to give a cycle of 14 hours light and 10 hours darkness.

Environmental conditions were monitored and recorded twice daily on weekdays and once daily at week-ends.

The animals were allowed free access to mains drinking water and food (SQC Standard Rabbit Diet. Special Diets Services Ltd., Stepfield) throughout the study.

Filtered water was dispensed via an automatic system.

A certificate relating to the quality of the drinking water was issued by the Yorkshire Water Authority. The diet and drinking water were not considered to contain any contaminant at a level that might have affected the purpose or integrity of the study.

Allocation to treatment groups
No formal randomisation procedure was adopted. On arrival at the laboratory the animals were placed into holding cages, one at a time, as they came to hand from the delivery crates working along the battery from left to right and from top to bottom, until each cage contained a single animal. Each animal served as its own control.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
single application
Observation period (in vivo):
72 h
Reading time points: 1, 24, 48 and 72 h
Number of animals or in vitro replicates:
3 females
Details on study design:
Treatment procedures
Each animal was held firmly but gently until quiet. A 'cup' was formed by gently pulling the lower lid of the left eye away from the eyeball and the test article (0.1 ml ) placed inside. Both the upper and lower lids were then held together for 1 - 2 seconds and the animal was released. The untreated right eye served as a control .

Irritation reactions were graded using the scale of Draize (Draize, J.H. (1959) Association of Food and Drug Officials of the U.S., Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics").

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritation parameter:
iris score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: reversibility: not applicable
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
3
Reversibility:
other: reversibility: not applicable
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
out of all 3 animals
Time point:
other: mean over 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: reversibility: not applicable
Irritant / corrosive response data:
No eye irritation was noted during the study period. The eye irritation scores were interpreted by a modified Kay and Calandra scoring system.

Other effects:
No other effects noted.

Any other information on results incl. tables

TABLE 1 Mean eye irritation scores

            Mean scores
 Time after treatment  Conjunctive (max 20)  Iris (max 10)  Cornea (max 80)  Mean total scores (max 110)
 1 hour  0  0  0  0
 1 day  0  0  0  0
 2 days  0  0  0  0
 3 days  0  0  0  0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified
Executive summary:

A sample of propylene glycol diacetate was evaluated for eye irritation testing.

This material, when instilled into the eyes of three New Zealand White rabbits, produced no signs of irritation. The mean scores after 24, 48 and 72 hours were 0. Hence, no classification is required according to EU criteria.