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:
November 18th 1980 to December the 12th 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
other: The procedure followed was a modification of that desribed by Draize
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: not stated
- Age at study initiation: about 3 months
- Weight at study initiation: 2 kg
- Housing: housed in galvanised or stainless steel cages
- Diet: Ad libitum
- Water: Ad libitum
- Acclimation period: Animals were acclimitised at least 3 days prior to test initiation

ENVIRONMENTAL CONDITIONS
- Temperature (°C): not stated
- Humidity (%): not stated
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12 hours light followed by 12 hours darkness

IN-LIFE DATES: From Day 0 To: End of study

Test system

Vehicle:
not specified
Controls:
other: yes, the other eye was used for control purposes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1ml


Duration of treatment / exposure:
single application
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): If any of the test article remained in the eye for 24 hours, the eye was washed out with lukewarm water after the 24 hour reading.
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE: not stated

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Remarks:
for all animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 1 hour
Irritant / corrosive response data:
The test material showed no effects to either the cornea, iris or conjuctivae.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not an occular irritant to rabbits under the conditions of the test.
Executive summary:

The test substance is not an occular irritant to rabbits under the conditions of the test.