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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:
weight of evidence
Study period:
12 December, 1978 - 4 January, 1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The quantiy of test material instilled in the sac of the eyes is not known. The study should have been carried out beyond 7 days to show reversibility in the animal that showed corneal opacity. Conducted prior to GLP, and the availability of OECD guidelines. No information on the purity of the test sample, limited information on the animals and the conditions of the testing (such as no information on temperature, humidity, how the test substance is instilled etc...).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Eye irritation was tested in 3 rabbits. Test substance was instilled into the eyes of the rabbits. The eyes were then washed for 1 minute with lukewarm water 30 seconds after instillation of the test material. The rabbits were observed for 72 hours. Corneal opacity and area, iris, and conjunctivae redness, chemosis and discharge were scored at the 24 hour, 48 hour, 72 hour and 7 day time points.
GLP compliance:
no

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): BUSAN 11-1M
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No.: 47601
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
- Other: No data

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Lesser's Rabbitry, Union Grove, WI
- Age at study initiation: No data
- Weight at study initiation: Males 2610 - 3058 g, female 3618 g
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): No data
- Humidity (%): No data
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): No data

IN-LIFE DATES: From: 88/12/1979 To: 04/01/1979

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
Duration of treatment / exposure:
30 seconds
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3 (2 male and 1 female)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The eyes were then washed for 1 minute with lukewarm water
- Time after start of exposure: 30 seconds

SCORING SYSTEM:
Draize, J.H. 1965, Appraisal of the safety of chemicals in foods, drugs and cosmetics, Associateion of the Food and Drug Officials of the US, Topeka, Kansas

TOOL USED TO ASSESS SCORE: No data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: mean of 24, 48, 72 timepoints
Score:
0.55
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Remarks on result:
other: A further timepoint may have established reversibility
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24, 48, 72 timepoints
Score:
0
Max. score:
2
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: mean of 24, 48, 72 timepoints
Score:
0.67
Max. score:
3
Reversibility:
fully reversible
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of 24, 48, 72 timepoints
Score:
0.22
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
No further data
Other effects:
No further data

Any other information on results incl. tables

No further data

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material caused mild and transient irritation to the eyes which is expected to be fully reversible and therefore is not classified for eye irritation/corrosion.
Executive summary:

In a study conducted in 1979, the potential of the test substance Busan 11-M1to cause irritation to the eyes was determined in rabbits. Three New Zealand White rabbits were administered a single ocular dose of the test substance unchanged. After 30 seconds, the eyes were washed for 1 minute with lukewarm water. The test animals were observed for 7 days after instillation.  Following application, the treated eyes elicited corneal opacity and conjunctival irritations. However, the conjunctival irritations had resolved by 7 days after instillation and it is expected that the cornea opacity would be fully reversible also, had the further time point of 14 days been examined. Based on these results, the test substance does not warrant classification for eye irritation in accordance with Regulation EC No. 1272/2008.