Registration Dossier

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment
Remarks:
No detail on methodology and results. All studies included in the report are brief summaries.

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:
not specified
Test type:
other: No data
Limit test:
no

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

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

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No data
Duration of exposure:
No data
Doses:
4640 mg/kg
No. of animals per sex per dose:
2 animals per dose
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs
Statistics:
No data

Results and discussion

Preliminary study:
Not applicable
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 4 640 mg/kg bw
Mortality:
No unscheduled deaths were recorded during the study
Clinical signs:
No signs of toxicity or local effects were noted during the course of the study.
Body weight:
No data
Gross pathology:
No data (not examined)
Other findings:
No data

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 for sodium trimetaphosphate in rabbits was determined to be > 4640 mg/kg. Due to the lack of methodological details and the lack of details regarding the purity of the test material this study is not considered to be acceptable for the purpose of classification and labelling in accordance with Regulation (EC) no. 1272/2008 (EU CLP). This study supports the conclusion that trisodium trimetaphosphate is not considered to be acutely toxic via the dermal route.