Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2005-10-05 to 2005-10-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Well documented study performed according to OECD and EC guidelines, in compliance with GLP. No deviation noted.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 00467090 (=charge 05C0836)
- Expiration date of the lot/batch: 2006-05-04
- Purity: 99.9%
- Purity test date: no data

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: at room temperature (range of 20 +/- 5°C), light protected
- Stability under test conditions: no data

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was applied undiluted as it was delivered by the sponsor.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: 1 male and 2 female young adult New Zealand White rabbits, SPF; Charles River Deutschland GmbH, Stolzenseeweg 32-36, D-88353 Kisslegg, Germany
- Age at treatment: 11-12 weeks (male), 10-12 weeks (females)
- Weight at first day of acclimatization: 2206 grams (male), 1811 - 1821 grams (females)
- Housing: Standard Laboratory Conditions; individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4642 (batch no. 42/05, Provimi Kliba AG) were provided for gnawing.
- Diet (e.g. ad libitum): ad libitum, pelleted standard Provimi Kliba 3418 rabbit maintenance diet
- Water (e.g. ad libitum): ad libitum, community tap water from Füllinsdorf
- Acclimation period: at least 5 days, under laboratory conditions after health examination. Only animals without any visual signs of illness were used for the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23°C
- Humidity (%): 30-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12, automatically controlled light cycle. Music was played during the daytime light period.

IN-LIFE DATES: From: 2005-10-10 (one female), 2005-10-11 (one male and one female) To: 2005-10-14

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/animal

VEHICLE
- No vehicle used.
Duration of treatment / exposure:
single dosing
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
one male and 2 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- The treated eyes were not rinsed after instillation.

SCORING SYSTEM:
- The ocular reaction (i.e. corneal opacity, iridic effects, conjunctivae and chemosis) was assessed according to the numerical scoring system listed in the Commission Directive 2004/73/EC, April 29, 2004, at approximately 1, 24, 48 and 72 hours after instillation.
- Additionally, ocular discharge, reddening of the sclerae and staining of conjunctivae, sclerae and cornea by the test item was assessed.
- When present, corrosion was recorded and reported.

TOOL USED TO ASSESS SCORE: Varta Cliptrix diagnostic-lamp (Roth AG, CH-4153 Reinach, Switzerland)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 55
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 55
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 55
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 55
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 56
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 56
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 56
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 56
Time point:
24/48/72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 57
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 57
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 57
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 57
Time point:
24/48/72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
IRRITATION:
- The mean score was calculated across 3 scoring times (24, 48 and 72 hours after instillation) for each animal for corneal opacity, iris, redness and chemosis of the conjunctivae, separately. The individual mean scores for corneal opacity and iris were 0.00 for all three animals. The individual mean scores for the conjunctivae were 0.00, 0.33 and 0.00 for reddening and 0.00, 0.33 and 0.00 for chemosis, respectively.
- No abnormal findings were observed in the iris of any animal at any of the measurement intervals.
- Very slight corneal opacity affecting the whole area was noted in one animal at the 1-hour reading.
- Slight to moderate reddening of the conjunctivae was noted in all animals one hour after treatment and persisted as slight reddening in one animal at the 24-hour reading.
- Slight swelling (chemosis) of the conjunctivae was observed in one animal at the 1- and 24-hour reading.
- Slight reddening of the sclerae was present in all animals one hour after treatment and persisted as slight reddening in one animal at the 24-hour reading.
- No abnormal findings were observed in the treated eye of any animal 48 hours after treatment.

CORROSION:
- No corrosion of the cornea was observed at any of the reading times.
Other effects:
- Viability/mortality: no clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.
- Coloration: no staining of the treated eyes produced by the test item was observed.
- Body weights: the body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based upon the referred classification (Commission Directive 2001/59/EC of August 06, 2001), TIC2782 (T002907) is considered to be “not irritating” to the rabbit eye. The test item is considered not to be classified based on CLP regulation.