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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: well performed, reliable, GLP compliant study, used in EU risk assessment for zinc oxide

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Principles of method if other than guideline:
none
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
see reference

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
see reference

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
64 mg ZnO (volume of 0.1 mL)
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48 and 72 hours after exposure
Number of animals or in vitro replicates:
3 males
Details on study design:
see reference

Results and discussion

In vivo

Results
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24-72 h
Score:
>= 0.7 - <= 1
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
No symptoms of systemic toxicity were observed and no mortality occurred. Slight iridial irritation (grade 1) was observed in one animal, at 1 hour only. Slight irritation of the conjuctivae (grade 1-2) was seen as redness (mean scores over 24-72 hours 0.7, 1 and 1), which had completely resolved at 72 hours in all animals. Chemosis (grade 2) and discharge (grade 1) were also observed in all animals, but at 1 hour only. No corneal opacity or epithelial damage was observed in any of the animals
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Executive summary:

In an eye irritation/corrosion well-performed study according to Directive 92/69/EEC B.5 and OECD guideline 405, three male New Zealand White rabbits were treated by instillation of approximately 64 mg of zinc oxide (a volume of about 0.1 ml) into the conjuctival sac of one eye. The other eye remained untreated and served as control. After 24 hours, both eyes of two animals were rinsed with water. The eyes were examined at 1, 24, 48 and 72 hours after instillation. No symptoms of systemic toxicity were observed and no mortality occurred. Slight iridial irritation (grade 1) was observed in one animal, at 1 hour only. Slight irritation of the conjuctivae (grade 1-2) was seen as redness (mean scores over 24-72 hours 0.7, 1 and 1), which had completely resolved at 72 hours in all animals. Chemosis (grade 2) and discharge (grade 1) were also observed in all animals, but at 1 hour only. No corneal opacity or epithelial damage was observed in any of the animals.