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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Adequate details; no COA; non-GLP. Needs test article id statement

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
other: FDA - Draize Test
Deviations:
not specified
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Cyclohexanone, peroxide
EC Number:
235-527-7
EC Name:
Cyclohexanone, peroxide
Cas Number:
12262-58-7
Molecular formula:
UVCB (equilibrium mixture of a number of cyclohexyl based organic peroxides, hydrogen peroxide, cyclohexanone and water)
IUPAC Name:
Peroxycyclohexanone
Constituent 2
Reference substance name:
Cyclonox LE
IUPAC Name:
Cyclonox LE
Test material form:
other: colorless liquid
Details on test material:
None provided. Only trade name and physical form provided. The purity was not provided. However, it is assumed to be 21% based on the information provided in another acute report, conducted during the same time frame, at the same laboratory.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
None provided.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
One tenth of a milliliter
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:
one
Details on study design:
The eyes of the animals are examined before testing and only those animals without observable eye defects are used. On tenth of a milliliter of the test substance is allowed to fall on the everted lower lid of 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 not washed following installation and the animals are released immediately.

The eyes are examined at 24, 48, 72 and 7 days after instillation of the test material.

An animal is considered as giving a positive reaction if there is, at any of the readings, discernible opacity of the cornea (other than a slight dulling of the normal lustre), or ulceration of the cornea, or inflammation of the iris (other than a slight deepening of the folds (rugae) or a slight circumcorneal injection), or if such substances produce in the conjunctivae (palpebral and bulbar, excluding the cornea and iris) an obvious swelling with partial eversion of the lids, or a diffuse deep-crimson red with individual vessels not easily discernible. The FDA scoring scale was used.

Ocular reactions are read using a binocular magnifying glass. The diagnosis of corneal damage is confirmed if necessary by staining the eyes of the animals with fluorescein-impregnated papers. After flushing the excess fluorescein solution, the eyes are examined in a dark room under ultraviolet illumination.

A substance which has elicited corneal and/or iris lesions which have not cleared by the seventh day reading, is considered a severe eye irritant.


Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: only one animal used
Time point:
other: 24-hrs after instillation
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
after 7 days
Irritation parameter:
iris score
Basis:
animal: only one animal used
Time point:
other: 24 hours
Score:
1
Max. score:
2
Reversibility:
not reversible
Remarks:
after 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: only one used
Time point:
other: 24 hours
Max. score:
3
Reversibility:
not reversible
Remarks:
after 7 days
Remarks on result:
other: conjunctivae were necrotic
Irritation parameter:
chemosis score
Basis:
animal: only one used
Time point:
other: 24 hours
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
after 7 days
Irritation parameter:
cornea opacity score
Basis:
animal: only one used
Time point:
other: 48 hours
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
after 7 days
Irritation parameter:
iris score
Basis:
animal: only one used
Time point:
other: 48 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal: only one used
Time point:
other: 48 hours
Max. score:
3
Reversibility:
not reversible
Remarks:
after 7 days
Remarks on result:
other: conjunctivae were necrotic
Irritation parameter:
chemosis score
Basis:
animal: only one used
Time point:
other: 48 hours
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
after 7 days
Irritation parameter:
cornea opacity score
Basis:
animal: only one used
Time point:
other: 72 hours
Score:
>= 3 - <= 4
Max. score:
4
Reversibility:
not reversible
Remarks:
after 7 days
Irritation parameter:
iris score
Basis:
animal: only one used
Time point:
other: 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: i
Irritation parameter:
conjunctivae score
Basis:
animal: onnly one used
Time point:
other: 72 hours
Max. score:
3
Reversibility:
not reversible
Remarks:
after 7 days
Remarks on result:
other: conjunctivae were necrotic
Irritation parameter:
chemosis score
Basis:
animal: only one used
Time point:
other: 72 hours
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
after 7 days
Irritation parameter:
cornea opacity score
Basis:
animal: only one used
Time point:
other: 7 days
Score:
4
Max. score:
4
Reversibility:
not reversible
Remarks:
after 7 days
Irritation parameter:
iris score
Basis:
animal: only one used
Time point:
other: 7 days
Remarks on result:
other: iris not discernable
Irritation parameter:
conjunctivae score
Basis:
animal: only one used
Time point:
other: 7days
Max. score:
3
Reversibility:
not reversible
Remarks:
after 7 days
Remarks on result:
other: conjunctivae were necrotic
Irritation parameter:
chemosis score
Basis:
animal: only one used
Time point:
other: 7 days
Score:
3
Max. score:
4
Reversibility:
not reversible
Remarks:
after 7days
Irritant / corrosive response data:
Moderate to complete corneal opacity, slight iritis,
necrosis of the conjunctivae and swelling with lids
about half closed.
The ocular lesions suggested permanent blindness.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The test article caused very severe irreversible eye damage.
Executive summary:

The test article was evaluated for potential eye irritation. One tenth of a milliliter was instilled into one eye of one rabbit. Reactions were evaluated at 24,48, 72 hours and 7 days following instillation.

The test article induced very severe irreversible eye damage.