Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliable guideline study with limited information about the test item, please refer to IUCLID section 13 for read across justification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): 82-0146, MX-6059

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: New York State Rabbit Development, Hartwick, N.Y.
- Weight at study initiation: 2 - 4 kg
- Housing: individually housed in wire mesh bottom cages in an environment-controlled room and quarantined for a minimum of 5 days
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:
6 animals (no wash-out)
3 animals (wash-out 4s after instillation)
Observation period (in vivo):
24, 48, 72 h, 7 days
Number of animals or in vitro replicates:
6 animals (no wash-out)
3 animals (wash-out 4s after instillation)
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): done in 3 animals
- Time after start of exposure: 4s after instillation

SCORING SYSTEM: Draize scale

TOOL USED TO ASSESS SCORE: eyes were examined with sodium fluorescein and an ultraviolet lamp

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24,48,72 h
Score:
0
Max. score:
3
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:
chemosis score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
None of the animals showed signs of irritation after instillation of the test item in the eye.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Conclusions:
The test article is considered to be non-irritating to the rabbit eyes without a washout and with a washout 4 seconds after instillation.
Executive summary:

The eyes of six animals were not washed out after instillation of the test article. The eyes of 3 animals were washed out, approximately 4 seconds after instillation of the test article, by flushing with physiological saline until all visible test article was removed.

Single application of the test item in the eyes of 9 rabbits was well-tolerated (primary irritation score = 0.0).

Based on this result it can be expected that the test item is not irritating to eyes.