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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14th October 1986 to 17th October 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: pale yellow solid block
Details on test material:
- Name of test material (as cited in study report): Dantocol DHE
- Physical state: pale yellow solid block
- Lot/batch No.: M5469330
- Storage condition of test material: room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
Single treatment.
Observation period (in vivo):
1, 24, 48 and 72-hours.
Number of animals or in vitro replicates:
Nine animals were inclued at the start of the study, however 1 animal died following exposure. This was attributed to a chest infection rather than treatment-related.
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 6 animals had a washout 1 second following expsoure and 3 animals had a washout following 30 seconds of exposure.

SCORING SYSTEM:

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: No effect seen
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Reversibility:
other: No effect seen.
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0.25
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 hours

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material was found to be slightly irritating to the eyes of rabbits under the conditions of this study. No effects were observed on the cornea or iris, however slight conjunctival effects were observed, which were fully reversible.
Executive summary:

In an in vivo eye corrosion/irritation study New Zealand White rabbits (8 animals) were exposed to the undiluted substance (single treatment) followed by observations at 1 -, 24 -, 48- and 72 -hours. The results of the study indicate that the substance is a non-irritant to the eye.