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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.