Registration Dossier

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: The test parameters evaluated in this study do not totally comply with a specific test guideline, but are documented and scientifically acceptable.

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
The test material containing 1% PO4 (as Na,HPO4) plus 100 ppm fluoride (as sodium fluoride) was assessed for its irritation potential by applying it undiluted to one eye of each of three rabbits.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
1% PO4, as Na2HPO4 + 100 ppm fluoride, as sodium fluoride
IUPAC Name:
1% PO4, as Na2HPO4 + 100 ppm fluoride, as sodium fluoride
Details on test material:
- Name of test material (as cited in study report): Test substance identified was UJD-8341, UDX-5594
- Physical state: Liquid
- Composition of test material, percentage of components: 1% PO4, as NaPO4 and 100 ppm fluoride, as NaF

Test animals / tissue source

Species:
rabbit
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Not known



Duration of treatment / exposure:
24 hours
Observation period (in vivo):
24 hours
Number of animals or in vitro replicates:
3
Details on study design:
The test material was applied undiluted to one eye of each of three rabbits. The test eyes were not rinsed.

Results and discussion

In vivo

Results
Irritation parameter:
other: maximum average score
Basis:
other: Two test eyes had a score of 2 and one test eye had a score of 0 at 1 hour after dosing. All three test eyes had a score of 0 at 24 hours after dosing.
Time point:
other: 1 hour after dosing
Score:
>= 0 - <= 2
Max. score:
1.3
Reversibility:
fully reversible within: 24 hours
Remarks on result:
other: only slight conjunctivitis was observed at 1 hour after dosing in two of the three test eyes.
Irritant / corrosive response data:
Two test eyes had a score of 2 and one test eye had a score of 0 at 1 hour after dosing. All three test eyes had a score of 0 at 24 hours after dosing.

Applicant's summary and conclusion

Interpretation of results:
other: Irritating but not sufficient to be classified by EU CLP criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The undiluted test material containing 1% PO4, as Na2HPO4, and 100 ppm fluoride, as sodium fluoride, caused very mild irritation to the eyes of rabbits. Slight conjunctivitis was produced in two of the three test eyes at 1 hour after dosing. The Irritation was fully reversible as no irritation was observed 24 hours after dosing.