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: Pre-GLP study following a method equivalent to a recognised guideline.

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:
according to
Guideline:
other: 16 CFR 1500.42
Deviations:
no
GLP compliance:
no

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: 8 weeks
- Weight at study initiation: not reported
- Housing: housed 2/cage in suspended wire mesh cages {30" x 18" x 18"}.
- Diet: Rabbit chow ad libitum
- Water: ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- 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:
3 days
Observation period (in vivo):
3 days
Number of animals or in vitro replicates:
5 males; 1 female
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No.

SCORING SYSTEM: Draize scoring system. Reference 16 CFR 1500.42.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: day 1
Score:
0
Max. score:
80
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: day 2
Score:
0
Max. score:
80
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: day 3
Score:
0
Max. score:
80
Irritation parameter:
iris score
Basis:
mean
Time point:
other: day 1
Score:
2.5
Max. score:
10
Reversibility:
fully reversible within: 72h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: day 2
Score:
2.5
Max. score:
10
Reversibility:
fully reversible within: 72h
Irritation parameter:
iris score
Basis:
mean
Time point:
other: day 3
Score:
0
Max. score:
10
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: day 1
Score:
10.33
Max. score:
20
Reversibility:
not fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: day 2
Score:
7.67
Max. score:
20
Reversibility:
not fully reversible within: 72h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: day 3
Score:
4.67
Max. score:
20
Reversibility:
not fully reversible within: 72h
Irritant / corrosive response data:
No positive corneal scores were noted. Four animals had positive iridal scores. The irritation generally persisted through day 2. All animals had positive conjuncitival scores. The conjunctival irritation generally persisted through day 2.

Applicant's summary and conclusion

Interpretation of results:
not classified
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 16 CFR 1500.42 following a guideline similar to OECD 405. 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. No corneal opacity or irritation was observed on any day and iridal irritation was observed in four animals. Conjunctival irritation was observed in all test animals on all 3 days. Under the conditions of this study the test material is considered to be an 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. Further there was complete absence of Corenal Opacity and very low order Corneal Iritis which is indicative of full reversibility of effects within 21-days. 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.