Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well documented study following a method equivalent to recognised guidelines in accordance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
other: 16 CFR 1500.42
Deviations:
no
Qualifier:
according to
Guideline:
other: Modification of a procedure described by Draize: J.H. Draize, "Dermal Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (The Association of Food and Drug Officials of the United States, 1975), pp. 49-51.
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Physical state: liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: 12 weeks
- Weight at study initiation: approximately 2kg.
- Housing: housed individually in galvanized or stainless steel cages
- Diet: Rabbit chow ad libitum
- Water: ad libitum
- Acclimation period: 3 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not reported.
- Humidity (%):not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days. Observations at 24, 48, 72 hours and 4 and 7 days.
Number of animals or in vitro replicates:
6 (six)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, any residual test article remained in the eye this was removed with saline after the 24 hour reading.
- Time after start of exposure: 24 hours.

SCORING SYSTEM: Proceedure followed a modification to that described by J.H. Draize. Numerical scores were assigned to lesions observed according to the Draize scale. The presence of lesions not described in the Draize scale was also noted.

J.H. Draize, "Dermal Toxicity", Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics (The Association of Food and Drug Officials of the United States, 1975), pp. 49-51.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0.775
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Based on applicant's recalculation of the scoring; all organisms
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0.385
Max. score:
2
Reversibility:
not fully reversible within: 4 days
Remarks on result:
other: Based on applicant's recalculation of the scoring; all organisms
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0.998
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Based on applicant's recalculation of the scoring; all organisms
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72h
Score:
0.998
Max. score:
4
Reversibility:
fully reversible within: 4 days
Remarks on result:
other: Based on applicant's recalculation of the scoring; all organisms
Irritant / corrosive response data:
Irritation response data is presented in table 1.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test substance cannot be considered as an eye irritant.
Executive summary:

The study was performed to assess the irritancy potential of the test material to the eye following a single application in the New Zealand White rabbit. The non-GLP study was completed under a method similar to OECD 405 and following definitions similar to the US 16 CFR 1500.42. A volume of 0.1 ml of the test material was placed into the conjunctival sac of one eye of 6 animals. The other eye remained untreated and was used for control purposes. Assessment of ocular damage/irritation was made approximately 24, 48 and 72 hours following treatment, and further assessments made at 4 and 7 days using scoring based on Draize et al. Corneal, iritis and conjunctival irritation was observed in the majority of test animals on all 3 days. Under the conditions of this study the test material is considered to be a mild eye irritant. Based on the applicants recalculation of the mean scores following grading at 24, 48 and 72h, 4 out of 6 organisms mean scores did not meet the EU classification criteria. The mean scores indicated that not more than three organisms met a positive scoring criteria for corneal opacity which in all cases fully reversed within 7 days. Furthermore there was an absence of significant variation in effects. Mean iritis and conjunctival scores in all organisms were insufficient for classification purposes. The substance has the potential to produce mild transient eye irritation but is insufficient for classification. Therefore the substance cannot be considered as an eye irritant under Regulation (EC) 1272/2008.