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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to standards

Data source

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

Materials and methods

Principles of method if other than guideline:
Eye irritation/corrosion test
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Pentanediamine, 2-methyl (MPMD)
-Composition of test material, percentage of components:
2-Methylpentamethylenediamine 99.2 %
3-methylpiperidine 0.1 %
H2O 0.4 %

Test animals / tissue source

Species:
rabbit
Strain:
other: Albino

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
at least 20 seconds
animal #1: eye washed after 20 sec for 1 min
animal #2: eye washed after 20 sec for 15 min
animal #3: no washing
Observation period (in vivo):
1 and 4 h and 1, 2, 3, 7, 10, 11 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tap water for 1 minute in animal #1 and for 15 minutes in animal #2, but not in animal #3
- Time after start of exposure: 20 seconds

SCORING SYSTEM: no data

TOOL USED TO ASSESS SCORE: hand-slit lamp at all examinations; Fluor-i-strip stain, Hemestix and a biomicroscope were used at examination after the day of treatment

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Remarks:
(descrption of general effects)
Basis:
animal #1
Time point:
other: all
Remarks on result:
other: severe corneal irritation with large ulcer, moderate iritis, clouds of precipitate in the anterior chamber, and necrosis of the conjunctiva and outer lids. At ten days the eye appeared shriveled and at 11 days the animal was sacrificed.
Irritation parameter:
overall irritation score
Remarks:
(descrption of general effects)
Basis:
animal #2
Time point:
other: all
Remarks on result:
other: Water washing for 15 min did not lessen the ocular effects. This eye was similar to the one washed for 1 minute.
Irritation parameter:
overall irritation score
Remarks:
(descrption of general effects)
Basis:
animal #3
Time point:
other: all
Remarks on result:
other: immediate, complete corneal opalescence and necrosis of the conjunctiva and outer lid in the unwashed rabbit eye. Effects on the iris were not seen due to the severity of the corneal irritation; at 1-3 days the eye did not react to light
Irritant / corrosive response data:
- animal #1: In the eye washed for 1 min the test substance caused severe corneal irritation with large ulcer, moderate iritis, clouds of precipitate in the anterior chamber, and necrosis of the conjunctiva and outer lids. At ten days the eye appeared shriveled and at 11 days the animal was sacrificed.
- animal #2: Water washing for 15 min did not lessen the ocular effects. This eye was similar to the one washed for 1 minute.
- animal #3: test substance caused immediate, complete corneal opalescence and necrosis of the conjunctiva and outer lid in the unwashed rabbit eye. Effects on the iris were not seen due to the severity of the corneal irritation; however, at 1-3 days the eye did not react to light. The rabbit was sacrificed at three days because of the obvious corrosive nature of the test material.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the test the test substance is corrosive to the rabbit eye.
Executive summary:

An eye irritation/corrosion test was performed with three rabbits. The animals were exposed to 0.1 ml of test substance. In the first animal (eye washed for 1 min after 20 seconds of exposure) the test substance caused severe corneal irritation with large ulcer, moderate iritis, clouds of precipitate in the anterior chamber, and necrosis of the conjunctiva and outer lids. At ten days the eye appeared shriveled and at 11 days the animal was sacrificed. The eye of animal 2 was washed for 15 min after 20 seconds of exposure, this did not lessen the ocular effects in comparison to animal 1. The eye of animal 3 was not washed after test item application. The test substance caused immediate, complete corneal opalescence and necrosis of the conjunctiva and outer lid. Effects on the iris were not seen due to the severity of the corneal irritation; however, at 1-3 days the eye did not react to light. The rabbit was sacrificed at three days because of the obvious corrosive nature of the test material.