Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed, reliable, GLP compliant study, used in EU risk assessment for zinc phosphate

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:
100 mg zinc phosphate
Duration of treatment / exposure:
up to 72 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

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 48 h
Score:
0.7
Remarks on result:
other: seen as redness
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 h
Score:
0.3
Remarks on result:
other: seen as redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 h
Score:
0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 48 h
Score:
0.3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 72 h
Score:
0.3
Irritant / corrosive response data:
Very slight irritation of the conjuctivae (grade 1) was seen as redness (mean scores over 24-72 hours 0, 0.7 and 0.3) and chemosis (mean scores 0, 0.3 and 0.3), which persisted up to 48 hours at the latest. No conjunctival discharge and no iris and corneal lesions were observed.
Other effects:
none

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Zinc phosphate is not irritating in an vivo rabbit study.
Executive summary:

In a well-performed eye irritation study, conducted according to Directive 92/69/EEC B.5 and OECD guideline 405, 100 mg of zinc phosphate was administered into the conjuctival sac of the left eye of three male New Zealand White rabbits. The right eye remained untreated and served as control. The eyes (unrinsed) were examined at 1, 24, 48 and 72 hours after administration.Very slight irritation of the conjuctivae (grade 1) was seen as redness (mean scores over 24-72 hours 0, 0.7 and 0.3) and chemosis (mean scores 0, 0.3 and 0.3), which persisted up to 48 hours at the latest. No conjunctival discharge and no iris and corneal lesions were observed.