Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Remarks:
Study was performed prior to the update of the REACH Regulation and prior to the validation of in vitro test methods.
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
1971

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No details on methodology included within study report.
GLP compliance:
no
Remarks:
Study pre-dates GLP

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material : sodium trimetaphosphate
- Analytical purity: No data

Test animals / tissue source

Species:
rabbit
Strain:
not specified
Details on test animals or tissues and environmental conditions:
No data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied : 10 mg
Duration of treatment / exposure:
No data
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
6 per treatment
Details on study design:
No data

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: all animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no effects noted
Remarks on result:
other: opacity
Irritation parameter:
iris score
Basis:
other: all animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: not applicable; no effects noted
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
other: all animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: not applicable; no effects noted
Irritation parameter:
chemosis score
Basis:
other: all animals tested
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable, no effects noted
Irritant / corrosive response data:
No effects were observed.
Other effects:
No data

Any other information on results incl. tables

Table 1 : In vivo eye irritation results in rabbits for sodium trimetaphosphate (2 animals)

Animal

Time point (hrs)

Cornea

Iris

Conjunctivae

Score

Opacity

Area

Score

Iris

Score

Erythema

Oedema

Redness

Male

0

0

0

0

0

0

0

0

0

0

24

0

0

0

0

0

0

0

0

0

48

0

0

0

0

0

0

0

0

0

72

0

0

0

0

0

0

0

0

0

Female

0

0

0

0

0

0

0

0

0

0

24

0

0

0

0

0

0

0

0

0

48

0

0

0

0

0

0

0

0

0

72

0

0

0

0

0

0

0

0

0

Table 2 : In vivo eye irritation results (total scores) in rabbits for sodium trimetaphosphate

 

Dose/Response Data

Eye Structure

Number Responding/Mean Score for 6 Rabbits

24 Hours

48 Hours

72 Hours

Cornea

0/0

0/0

0/0

Iris

0/0

0/0

0/0

Conjunctivae

0/0

0/0

0/0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The paper concludes that the irritant rating of sodium trimetaphosphate in rabbits is a non-irritant.
This study is considered to support a conclusion of no classification under Regulation (EC) No. 1272/2008 (EU CLP), as part of a weight of evidence approach, as the the data clearly shows that at all time points and for relevant parameters no effects were observed.