Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
An in vitro eye irritation study does not need to be conducted because adequate data from an in vivo study are available.
Type of information:
other: read across from supporting substance
Adequacy of study:
key study
Study period:
September 11, 1975
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:
1975
Report Date:
1975

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: "Hazardous Substances Regulations" under the U.S.A. federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965)
Deviations:
not specified
GLP compliance:
no
Remarks:
Study conducted before 1981

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain: Porton strain
- Age at study initiation: 9-15 weeks old
- Weight at study initiation: 2.44 kgs. (♂) 30d 2.10 kgs. (♀)
- Housing: bred on the premises and maintained under a semi-barrier system
- Diet: A commercial irradiated diet (Styles-Oxoid) was fed ad libitum
- Water: Sterile filtered water was available at all times
- Acclimation period: one week prior to the start of the trial

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1°C
- Humidity (%): 50-70 %
- Photoperiod (hrs dark / hrs light): Animals were exposed to artificial light for 10 hours daily from 08.00-18.00 hours

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 100 mg
Duration of treatment / exposure:
Single injection
Observation period (in vivo):
The rabbits were examined 1, 24, 48 and 72 hours, 6, 10 and 14days after application of the test compound and for any further period that was considered necessary.
Number of animals or in vitro replicates:
5 male and 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: yes, after 30 seconds the compound was, as far as possible, flushed out of the eye of three of the rabbits with warm water for 1 minute

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 14, 15, 16
Time point:
other: Mean score after 24, 48 and 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: no eye effect observed
Remarks on result:
other: Rinsed
Irritation parameter:
conjunctivae score
Basis:
animal: 14, 15
Time point:
other: Mean score after 24, 48 and 72 hours
Score:
ca. 1
Max. score:
3
Reversibility:
not fully reversible within: 72 hours
Remarks on result:
other: Rinsed
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: 16
Time point:
other: Mean score after 24, 48 and 72 hours
Score:
ca. 1.33
Max. score:
3
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: Rinsed
Irritation parameter:
chemosis score
Basis:
animal: 14, 15
Time point:
other: Mean score after 24, 48 and 72 hours
Score:
ca. 0
Max. score:
4
Reversibility:
other: no eye effect observed
Remarks on result:
other: Rinsed
Irritation parameter:
chemosis score
Basis:
animal: 16
Time point:
other: Mean score after 24, 48 and 72 hours
Score:
ca. 0.66
Max. score:
4
Reversibility:
fully reversible within: 6 days
Remarks on result:
other: Rinsed

Any other information on results incl. tables

A slight to mild conjunctival reaction was seen in all treated eyes one hour after application of the compound. Generally there was very little change by 24 hours and thereafter the reactions subsided slowly with 3/3 washed and 2/3 unwashed eyes returning to normal as follows:- 72 hours (2/3 washed eyes), 6 days (1/3 washed eyes) and 10 days (2/3 unwashed eyes). The remaining unwashed eye still showed a very slight reaction at the termination of the study on day 14. Staining of the conjunctivae by the compound was seen in all eyes for up to 48 hours in the washed eyes, 10 days for 2/3 unwashed eyes and the duration for the remaining eye.

A slight corneal reaction consisting of slight opacity and damage to the surface epithelium was seen in 2/3 unwashed eyes at 24 and 48 hours. Staining of the cornea by the compound was also seen in the unwashed eyes for up to 10 days for 2/3 and the duration for the remaining one.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation (EC n. 1272/2008)
Conclusions:
The substance is not irritating for rabbit eyes.
Executive summary:

The substance has been tested for eye irritation according to The method "Hazardous Substances Regulations" under the U.S. federal Hazardous Substances Labelling Act Sect. 191.12 (February 1965). During the test 5 male and 1 female rabbits are treated with 100 mg of the test compound. After 14 days only one animal (n. 13) showed a redness score (1), nevertheless in order to evaluate the irritation potential of the test item this animal was not considerd because his eyes were not rinsed after application.

The substance is considered to be not irritant for rabbit eyes.