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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:
20.05. - 23.05.2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): Isocarb 24
- Substance type: Product
- Lot/batch No.: ISC2403, 04058/MA
- Physical state: crystalline at ambient conditions

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Italia S. p. A. (Como) (supplier), P.O.A.D.A. Mandello Lario (CO) (breeder), Italy
- Age at study initiation: 9 to 11 weeks
- Weight at study initiation: 1.8 - 2.3 kg
- Housing: Animals were individually housed in stainless steel cages measuring 69x45x51 cm and equipped with grid floors. Cages were suspended over trays and each tray held an absorbent material which was inspected daily and changed as necessary. Throughout the study each cage was identified by a colour coded label recording the study number, animal number and the details of treatment. This colour coding matched the corresponding colour coded formulation container.
- Diet (e.g. ad libitum): a commercially available anti-biotic free pelleted laboratory diet (Altromin MSK, Altromin, D-32770, Lage Postfach 1120, Germany ad libitum throughout the study.
- Water (e.g. ad libitum): Animals were offered drinking water supplied to each cage via water bottles.
- Acclimation period: 10 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19°C ± 2°C
- Humidity (%): 55% ± 15%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: To: 08.04.2002 - 23.05.2002

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated left eye
Amount / concentration applied:
- Amount of substance instilled: 0.1 g into the right eye
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
ADMINISTRATION/EXPOSURE
- Preparation of test substance: The test substance was applied undiluted.
- Amount of substance instilled: 0.1 g
- Vehicle: none
- Postexposure period: 72 hours
EXAMINATIONS
- Ophtalmoscopic examination: the treated eye examined macroscopically for damage or irritation to the cornea, iris and conjunctivae using the untreated eye as a comparator control.
- Scoring system: according to OECD 405
- Observation period: Ocular reactions were recorded 1, 24, 48 and 72 h after application.
- Tool used to assess score: not mentioned

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Irritant / corrosive response data:
Slight redness was noted in 1 animal at the 1 hour examination. No reaction to treatment was observed at the 24, 48 or 72 hour post-dose examinations.
Other effects:
There was no indication of a systemic effect of treatment. Changes in body weight during the course of the study were not remarkable.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute eye irritation of the test substance was investigated in the rabbit. A 0.1 g aliquot of the substance was introduced into the right eye of a total of 3 animals. The resulting reaction to treatment was assessed 1, 24, 48 and 72 hours after dosing. Slight redness was noted in 1 animal at the 1 hour examination. No irritation was apparent at the 24, 48 or 72 hour post-dose examinations. The results of this study indicated that the test item has no significant irritant effect in the eye.
Executive summary:

The results of this study indicated that the test item has no significant irritant effect in the eye.