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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:
10 July to 13 July 2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report: T 7479
- Physical state: Clear colorless liquid
- Analytical purity: Not Specified buy treated as 100%
- Expiration date of the lot/batch: 23 March 2002

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland Kisslegg Germany
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: 1.0-3.5 kg
- Housing: Individually housed in perforated cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: At least 5 days before start of treatment
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 plus/minus 3 C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light
IN-LIFE DATES: From: 10 July 2001To: 13 July 2001

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
3 Days (material was not rinsed from the eyes)
Observation period (in vivo):
3 Days
Number of animals or in vitro replicates:
3 animals; all males
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No
- Time after start of exposure:
SCORING SYSTEM: Numbered scoring system of 1-4 for corneal irritation, area of cornea, iris, conjunctival irriation, chemosis and discharge.
TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: All time points
Score:
0 - 1
Max. score:
1
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: No irritation was seen in any of the animals

Any other information on results incl. tables

24 -72 hour mean scores

Animal #

Corneal Opacity

Iris

Conjuncitvae Redness

Conjunctivae Chemosis

680

0

0

0

0

679

0

0

0

0

681

0

0

0

0

 

 

 

 

 

Mean 24-72 hours

Applicant's summary and conclusion

Interpretation of results:
other: not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Test Substance is not irritating.
Executive summary:

Study was conducted according to OECD No. 405, 'Acute Eye Irritation/Corrosion. Single samples of 0.1 ml of the test substance were instilled into one eye of each of three male rabbits. Observations were made 1, 24, 48 and 72 hours after instillation. Instillation of the test substanceresulted in the irritation of conjunctivae of one rabbit, which was seen as redness. The irritation had completely resolved within 24 hours.

Based on these results and according to EC criteria for classification and labelling, the test substance does not have to be classified and has no obligatory labelling requirement for eye irritation.