Registration Dossier
Registration Dossier
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EC number: 231-944-3 | CAS number: 7779-90-0
Eye irritation
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:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- none
- GLP compliance:
- yes
Test material
- Reference substance name:
- Trizinc bis(orthophosphate)
- EC Number:
- 231-944-3
- EC Name:
- Trizinc bis(orthophosphate)
- Cas Number:
- 7779-90-0
- Molecular formula:
- H3O4P.3/2Zn
- IUPAC Name:
- trizinc bis(orthophosphate)
- Details on test material:
- see reference
Constituent 1
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:
- 24 h
- Score:
- 0
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- 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:
- GHS criteria not met
- 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.
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