Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was performed pre-GLP and pre-guideline. The report is very concise. No data on test item composition or purity.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
In general the techniques of tests as published by the FDA of the United States (Fed. Reg. (119), 5582, 1963) and Draize and Kelley (Drug Cooset. Industr. 11 (1952) 36) are followed.
GLP compliance:
no
Remarks:
pre-GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Perkadox 24
di-cetyl peroxydicarbonate
solid
storage at -20°C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: caged individually
- 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: no data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The other eye, remaining untreated, serves as a control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
single exposure, no washing
Observation period (in vivo):
The eyes are examined at 24, 48, 72 hours and 7 days after instillation of the test material.
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: binocular ( text cannot be read) with UV illumination

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-48-72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-48-72 hours
Score:
0.66
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
all animals
Time point:
other: 24-48-72 hours
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
The eye lesions caused by the test substance were of a slight degree, see table.
Other effects:
None

Any other information on results incl. tables

Summary of ocular lesions mean of 6 animals per group 

Animal

Effect

Time after application

Average 24/48/72h 

24 h

48 h

72 h

7 d

 

7

Cornea

Iris

Redness

Chemosis

0

0

1

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0.66

0

8

Cornea

Iris

Redness

Chemosis

0

0

1

1

0

0

1

1

0

0

1

0

0

0

0

0

0

0

1

0.66

9

Cornea

Iris

Redness

Chemosis

0

0

1

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0.66

0.33

10

Cornea

Iris

Redness

Chemosis

0

0

< 2

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

1

0.33

11

Cornea

Iris

Redness

Chemosis

0

0

> 1

1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0.66

0.33

12

Cornea

Iris

Redness

Chemosis

0

0

< 2

1

0

0

1

1

0

0

1

0

0

0

0

0

0

0

1.33

0.66

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The eye lesions caused by the test substance were of a slight degree and do not require classification for eye irritation.
Executive summary:

Eight chemical products, all organic peroxides, were examined for eye irritating properties in experiments with albino rabbits. All products examined caused ocular lesions. Based on the effects the test substance is not classified.