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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:
comparable to guideline study with acceptable restrictions

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:
no
Qualifier:
equivalent or similar to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Principles of method if other than guideline:
In general the techniques of tests as published by FDA of the United States (Fed. Reg. 28 (119), 5582, 1963) and Draize and Kelley Drug Cosmet. Industr. 71 (1952) 36) are followed.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: individually


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: one tenth of a milliliter of the test substance


Duration of treatment / exposure:
single treatment
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: the eyes are not washed following instillation


SCORING SYSTEM:
- Cornea:
No ulceration or opacity: 0
Scattered or diffuse areas of opacity (other than slight dulling of normal luster), details or iris clearly visible: (1)*
Easily discernible translucent areas, details of iris slightly obscured: 2
Nacrreous areas, no details of iris visible, size of pupil barely discernible: 3
Complete corneal opacity, iris not discernible: 4

- Iris:
Normal: 0
Markedly deepend folds, congestion, swelling, moderate circumcorneal injection (any of these or combination of any thereof), iris still reacting to light (sluggish reaction is positive): (1)*
No reaction to light, haemorrhage, gross detruction (any or all of these): 2

- Conjunctivae
1) Redness
Vessels normal: 0
Some vessels definitely injected: 1
Diffuse, crimson red, individual vessels not easily discernible: (2)*
Diffuse beefy red: 3

2) Chemosis
No swelling: 0
Any swelling above normal (includes nictitating membrane): 1
Obvious swelling with partial eversion of lids: (2)*
Swelling with lids about half closed: 3
Swelling with lids more than half closed: 4

* Bracket figures indicate lowest grades considered positive.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 hours
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 hours
Score:
0.2
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 hours
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritant / corrosive response data:
The eye lesions caused by the test item generally were of a slight degree. Thus, this test item is not considered to be eye irritant.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The eye lesions caused by tert-butyl peroxyneodecanoate generally were of a slight degree. Thus, this test item is not considered to be eye irritant.
Executive summary:

Tert-butyl peroxyneodecanoate (75 % in solvent) was examined for eye irritating properties in six New Zealand White albino rabbits. One tenth of a milliliter of the test item is allowed to fall on the everted lower lid one eye of each rabbit; the upper and lower eye lid are then carefully closed and subsequently held together for at least one second before releasing, to prevent loss of material. The other eye, remaining untreated, serves as a control. The eyes are examined at 24, 48, 72 hours and 7 days after instillation of the test item.

The eye lesions caused by the test item generally were of a slight degree with mean cornea score of 0, iris score of 0, conjuctivae score 0.2 and chemosis score 0. Thus, the test substance was not considered to be an eye irritant.