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:
72 hours
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Remarks:
Because the purity of the substance tested is not given in the study report, it is not possible to ascertain the degree to which the results represent the pure submission substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
A 250 g sample of the test substance was received from the sponsor on December 11, 1985. It was a clear, colourless, slightly viscous liquid, designated Trigonox C, no. 4285060690, and it was stated to be t. butylperbenzoate.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Healthy male, young adult, New Zealand White albino rabbits obtained from ENKI-Konijnenfarm, Someren, the Netherlands, were used as the experimental animals. The body weight range was 2500-3500 g. The animals were identified by earmarking.The animals were housed individually in suspended, galvanized cages, fitted with wire-mesh floor and front. The cages were placed in a room, controlled for light (12 hours light/dark cycle), temperature (18+/-3°C), ventilation (c. 10 air changes/hour), and relative humidity (40-70%) throughout the test period. A standard laboratory rabbit diet and tap water were provided ad libitum.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of each animal served as control
Amount / concentration applied:
0.1 ml - One tenth of a milliliter of the undiluted test substance was allowed to fall on the everted lower lid of one eye of each rabbit.
Duration of treatment / exposure:
After administration the upper and lower lid were carefully closed and subsequently held together for about one second before releasing, to prevent loss of material.
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Both eyes of each rabbit provisionally selected were examined within 24 hours before testing; three animals without observable eye defects were used. One tenth of a milliliter of the undiluted test substance was allowed tofall on the everted lower lid of one eye of each rabbit. After administration the upper and lower lid were carefully closed and subsequently held together for about one second before releasing, to prevent loss of material. The other eye remaining untreated, served as a control. The eyes were not washed out following administration and the animals were released immediately. Ocular reactions were judged using a scoring scale which is part of the attached complete report. Eye effects were examined after one hour, 24, 48 and 72 hours.

Results and discussion

In vivo

Results
Irritation parameter:
other: Maximum score recorded
Basis:
animal #2
Time point:
other: 1 hour
Score:
ca. 2
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritant / corrosive response data:
maximum score, any animal @ 1, 48 and 72 hours, respectively: 2*, 1*, 0

*chemosis and redness
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test substance caused slight or moderate redness and slight or moderate swelling of the conjunctivae in all (three) rabbits. After 72 hours, all eye effects had cleared completely. On the basis of the results obtained it was concluded that, according to the EEC-standards*, the undiluted test substance Trigonox C is not an eye irritant.
*EEC Directive 79-831, Annex V, Methods for the determination of toxicity, B.5. Acute toxicity, eye irritation, dated December 1983.
Executive summary:

The test substance caused slight or moderate redness and slight or moderate swelling of the conjunctivae in all (three) rabbits. After 72 hours, all eye effects had cleared completely. On the basis of the results obtained it was concluded that, according to the EEC-standards*, the undiluted test substance Trigonox C is not an eye irritant.

*EEC Directive 79-831, Annex V, Methods for the determination of toxicity, B.5. Acute toxicity, eye irritation, dated December 1983.