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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:
2004-03-23 to 2004-04-06
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Well documented GLP study performed according to the OECD Guideline 405 and the EC test method B.5.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report Date:
2004

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:
not specified
Details on test material:
- Name of test material (as cited in study report): T002251
- Physical state: brown powder
- Analytical purity: 96%
- Lot/batch No.: 00410155
- Expiration date of the lot/batch: 2004-05-05
- Storage condition of test material: at room temperature (range of 20 +/-3°C), light protected
- pH: before study initiation: A formulation of 1% in water was prepared. The pH was found to be 5.
- stability of test item: stable under storage conditions

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, F-01400 Chatillon sur Chalaronne / France
- Age at treatment: 14-15 weeks (male), 15-16 weeks (females)
- Weight at day of treatment: 2.592 - 2.986 kg
- Fasting period before study: no data
- Housing: standard laboraotry conditions, individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks and haysticks 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 6 days, under laboraotry 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
- Other: Music was played during the daytime light period

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the right eye remained untreated and served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 g , weighed and applied undiluted as it was delivered by the Sponsor
Duration of treatment / exposure:
single dose, unlimited exposure
Observation period (in vivo):
The eyes of each animal were examined approximately 1, 24, 48, 72 hours and 7 days after instillation.
Viability/mortality and clinical signs were assessed daily.
Individual body weights were recorded at start of acclimatization, on the day of application and at termination of observation
Number of animals or in vitro replicates:
3 (1 male number 37, 2 females number 38, 39)
As it was suspected that the test item might produce irritancy , a single female animal was treated first. As neither a corrosive effect nor a severe irritant effect was observed after the 1-hour and 24-hour examinations, the test was completed using the two remaining animals.
Details on study design:
REMOVAL OF TEST SUBSTANCE: the eyes were not rinsed after instillation

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

SCORING SYSTEM: The ocular reaction was assessed according to the numerical scoring system listed in the EEC Commission Directive 92/89/EEC, July 31, 1992 at approx 1, 24, 48 and 72 hours, as well as 7 days after instillation.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 37
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score 0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 37
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable - score 0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 37
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 37
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score 0
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 38
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score 0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 38
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable - score 0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 38
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 38
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score 0
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 39
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score 0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 39
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable - score 0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 39
Time point:
24/48/72 h
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 3 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 39
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable - score 0
Irritant / corrosive response data:
No abnormal findings were observed in the cornea or iris of any animal at any of the measurement intervals. Slight reddening of the conjunctivae was observed in all animals from the 1-hour reading up to 48 hours after treatment. Slight swelling (chemosis) was noted in all animals at the 1-hour examination. Moderate reddening of the sclerae was visible in all animals at the 1-hour reading. Slight reddening of the sclerae was observed in all animals 24 hours after treatment and persisted in one animal up to the 72-hour reading. Slight ocular discharge was evident in one animal 1 hour after treatment.
No corrosion of the cornea was observed at any of the reading times.
The individual mean scores for corneal opactiy and iris were 0 for all three animals. The individual mean scores for the conjunctivae were 0.67 for reddening and 0 for chemosis for all three animals. The effect on the conjunctivae was reversible.
Other effects:
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred. The body weights of all rabbits were considered to be within the normal range of variability.
No staining of the treated eyes produced by the test item was observed.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The results obtained, under these experimental conditions, enable to conclude that the substance T002251 is considered to be not irritating to the rabbit eye and therefore does not need to be classified.