Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
04.12.2001 - 13.12.2001 (experimental)
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 guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted February 24, 1987
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
July 31, 1992
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: light yellow powder
- Analytical purity: 99.1 %
- Lot/batch No.: 766/130
- Expiration date of the lot/batch: 31-AUG-2003
- Stability under test conditions: 4 hours
- Storage condition of test material: at room temperature (range of 20 ± 3 °C), protected from light.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Elevage Scientifique des Dombes, Chatillon sur Chalaronne / France
- Age at study initiation: 11-12 weeks (male), 10-11 weeks (females)
- Weight at the day of treatment: male: 2250 g; females: 2172 g and 2090 g
- Housing: Individually
- Diet (e.g. ad libitum): Pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 92/01) provided by Provimi Kliba
AG, Kaiseraugst, Switzerland. Haysticks (QS no. 125/01) provided by Eberle Nafag AG, Gossau, Switzerland.
- Water (e.g. ad libitum): Community tap water from Fuellinsdorf, ad libitum.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The right eye remained untreated and served as the reference control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g (per animal)

Duration of treatment / exposure:
single treatment
Observation period (in vivo):
1 to 72 hours
Number of animals or in vitro replicates:
3 (1 male, 2 females)
Details on study design:
TEST ITEM PREPARATION and TREATMENT
- The test item was applied undiluted and handeled in a dark room under red light.
- The test item was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the eyeball. The lids were
then gently held together for about one second to prevent loss of test item.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eyes were not rinsed after instillation.

SCORING SYSTEM:
- The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/69/EEC, July 31, 1992 at approximately 1, 24, 48 and 72 hours after application.

TOOL USED TO ASSESS SCORE: Eye examinations were made with a Varta Cliptrix diagnostic-lamp (A. Riegger, Basel / Switzerland).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
male
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
female
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
female
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
female
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
female
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
male
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
female
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
female
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
male
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
female
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
female
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: no effects
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Application of the test item to healthy rabbit conjunctivae resulted in a primary irritation score of 0.44.
The eye reactions (mean values from 24 to 72 hours) consisted of grade 0.00 corneal opacity, grade 0.00 iris lesions, grade 0.33 redness of the conjunctivae and grade 0.11 chemosis of the conjunctivae.
No abnormal findings were observed in the iris or cornea of any animal at any of the measuring intervals.
Slight reddening of the conjunctivae was observed in all animals 1 hour after treatment and persisted in one animal up to the 24-hour reading and in another animal up to the 48-hour reading.
Slight swelling of the conjunctivae or swelling with partial eversion of lids was noted in all animals 1 hour after treatment. Slight swelling was still evident in one animal at the 24-hour reading.
Slight to moderate reddening of the sclera was present in all animals at the 1 -hour reading and continued to be observed in one animal up to 24 hours after treatment.
A slight watery discharge was evident in one animal at the 1-hour reading.
No abnormal findings were observed in the treated eye of any animal 72 hours after treatment, the end of the observation period for all animals.
The test item did not induce significant or irreversible damage to the rabbit eye.
Other effects:
No signs of toxicity or ill health were observed in any animals.
No staining of the treated eye by the test item was observed.
Yellow remnants of the test item were present in the eye or conjunctival sac of two animals 1 hour after treatment.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was determined to be not irritating to rabbit eyes under the conditions of the test.
Executive summary:

In this guideline (OECD 405) study conducted to GLP standards, the test material (EC 438-340-0) did not induce any significant irritation in the rabbit eye at 24/48/72 hours. The test material was exposed to the 3 rabbits with an 6 day observation period. Based upon the results of this study, the test material does not meet the criteria for classification as an eye irritant under the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).