Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
no data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: comparable to guideline study with acceptable restriction

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
: no clinical observation after 1 h; 6 animals were used
Qualifier:
according to
Guideline:
other: Fed. Reg. 28 (119), 5582, 1963 (published by the FDA of the USA) and Draize and Kelley (Drug. Cosmet. Industr. 71 (1952) 36)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Perkadox 16 (Bis(4-tert-butylcyclohexyl)peroxydicarbonate)
- Substance type: organic peroxide
- Physical state: solid
- Storage condition of test material: -20°C

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: individually
- no hay or other extrageneous material that might enter the eye
- examination of the eyes before testing

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
Single treatment. The eyes were not washed after treatment. The exposure period is as long as observation period.
Observation period (in vivo):
Observation after 24 h, 48h, 72 h and 7 days after exposure.
Number of animals or in vitro replicates:
6 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no washing
SCORING SYSTEM: FDA scoring scale (see table 1)

TOOL USED TO ASSESS SCORE: binocular

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 48 h
Score:
ca. 0.83
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 72 h
Score:
ca. 0.5
Max. score:
1
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 48 h

Any other information on results incl. tables

Table 1: Individual scores awarded in the ocular lesions elicited by bis(4-tert-butylcyclohexyl) peroxydicarbonate    

Rabbit number

Cornea

Iris

Conjunctivae

Redness

Chemosis

After 24 hours

1

0

0

1

1

2

0

0

> 1

1

3

0

0

1

1

4

0

0

1

1

5

0

0

> 1

1

6

0

0

1

1

After 48 hours

1

0

0

1

0

2

0

0

1

0

3

0

0

1

0

4

0

0

0

0

5

0

0

1

0

6

0

0

1

0

After 72 hours

1

0

0

1

0

2

0

0

0

0

3

0

0

1

0

4

0

0

0

0

5

0

0

1

0

6

0

0

0

0

After 7 days

1

0

0

0

0

2

0

0

0

0

3

0

0

0

0

4

0

0

0

0

5

0

0

0

0

6

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:
Bis(4-tert-butylcyclohexyl) peroxydicarbonate causes ocular lesions of slight degree. According the FDA-Standards it is not considered to be an eye irritant.
Executive summary:

In a primary eye irritation study 100 mg of bis(4-tert-butylcyclohexyl) peroxydicarbonate was instilled into the everted lower lid of one eye of 6 New Zealand White albino rabbits for 24 hours. The eyes were not washed after instillation. Animals were observed after 24, 48 and 72 hours and after 7 days. Irritation was scored with the FDA scoring scale. After 24 hours grade 1 of conjunctivae redness and chemosis was observed in all animals. Chemosis was reversible in all animals after 24 hours, redness diminished after seven days. As in terms of conjunctivae irritation scores score 1 is not considered as positive effect and because of the fully reversibility of the effect, bis(4-tert-butylcyclohexyl) peroxydicarbonate is not considered to be an eye irritant.