Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 17 to 24 June 1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted in accordance with relevant guidelines. Not conducted under GLP conditions..

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch No.: not specified
Purity: not specified

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: young adult
- Housing: The animals were housed and maintained in compliance with the Animal Welfare Act 9 CFR Part 3.

No additional data

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

No additional data
Duration of treatment / exposure:
7 days
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test material was not washed from the eyes.

SCORING SYSTEM: Draize Scale of Scoring Ocular Lesions.

No additional data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects were observed during 7 day observation period.
Irritation parameter:
iris score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects were observed during 7 day observation period.
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects were observed during 7 day observation period.
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: No effects were observed during 7 day observation period.
Irritant / corrosive response data:
No information provided
Other effects:
No information provided

Any other information on results incl. tables

Individual Daily Scores

Rabbit number

Tissue

Item

Readings

1 day

2 day

3 day

5 day

7 day

1

Cornea

Opacity

Area

0

0

0

0

0

0

0

0

0

0

Iris

Value

0

0

0

0

0

Conjunctivae

Redness

Chemosis

Discharge

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

2

Cornea

Opacity

Area

0

0

0

0

0

0

0

0

0

0

Iris

Value

0

0

0

0

0

Conjunctivae

Redness

Chemosis

Discharge

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

3

Cornea

Opacity

Area

0

0

0

0

0

0

0

0

0

0

Iris

Value

0

0

0

0

0

Conjunctivae

Redness

Chemosis

Discharge

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

4

Cornea

Opacity

Area

0

0

0

0

0

0

0

0

0

0

Iris

Value

0

0

0

0

0

Conjunctivae

Redness

Chemosis

Discharge

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

5

Cornea

Opacity

Area

0

0

0

0

0

0

0

0

0

0

Iris

Value

0

0

0

0

0

Conjunctivae

Redness

Chemosis

Discharge

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

6

Cornea

Opacity

Area

0

0

0

0

0

0

0

0

0

0

Iris

Value

0

0

0

0

0

Conjunctivae

Redness

Chemosis

Discharge

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Methylenebis (dibutyldithiocarbamate) is not irritating to the rabbit eyes in this test.