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Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Basic data given, but considered sufficiently reliable for the purpose of hazard assessment
Cross-reference
Reason / purpose:
read-across: supporting information
Reference
Endpoint:
acute toxicity: dermal
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Cystus concrete and Cyste absolute are obtained from the same botanical source, the Cistus ladaniferus (Cistaceae).
Reason / purpose:
read-across source
Principles of method if other than guideline:
Standard acute method (limit test)
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
No data
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
No data
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No data
Duration of exposure:
No data
Doses:
5 000 mg/kg bw
No. of animals per sex per dose:
No data
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
No data
Preliminary study:
No data
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
No mortality
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Other findings:
The test material adhered tightly to the skin and could not be removed with standard washing procedures. the skin surface was therefore obscured and initial erythema would have escaped detection.
Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS. Therefore, the registered substance is not considered toxic by dermal route.
Executive summary:

In an acute dermal toxicity study (limit test), rabbits were given a single dermal application of the test item at 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.

No mortality or clinical signs was observed.

In this study, the dermal LD50 of the test item was higher than 5000 mg/kg bw in rats.

Under the experimental conditions of this study, the test item is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS. Therefore, the registered substance is not considered toxic by dermal route.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973
Report Date:
1973

Materials and methods

Principles of method if other than guideline:
Standard acute method (limit test)
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
RIFM ID 358
Specific details on test material used for the study:
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:
5 000 mg/kg bw
No. of animals per sex per dose:
No data
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
Statistics:
No data

Results and discussion

Preliminary study:
No data
Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
No data
Body weight:
No data
Gross pathology:
No data
Other findings:
The test material adhered tightly to the skin and could not be removed with standard washing procedures. the skin surface was therefore obscured and initial erythema would have escaped detection.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the experimental conditions of this study, the test substance is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.
Executive summary:

In an acute dermal toxicity study (limit test), rabbits were given a single dermal application of the test item at 5000 mg/kg bw. Animals were observed for mortality and clinical signs for 14 days.

No mortality or clinical signs was observed.

In this study, the dermal LD50 of the test item was higher than 5000 mg/kg bw in rats.

Under the experimental conditions of this study, the test item is not classified according to Regulation (EC) No. 1272/2008 (CLP) and to GHS.