Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A well-conducted study, considered adequate for assessment

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1971
Reference Type:
secondary source
Title:
European Union Risk Assessment Report, alkanes C10-13, chloro
Author:
EU
Year:
2000
Bibliographic source:
European Union Risk Assessment Report (RAR), final

Materials and methods

Principles of method if other than guideline:
A undiluted C10-13 chlorinated paraffin (52% chlorination) was applied to the skin of rats under an occlusive dressing for 24 h and signs of systemic toxicity (and irritation) were assessed for at least 7 days.
GLP compliance:
no
Remarks:
Prior to GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C10-13 chlorinated paraffin (52% chlorinated)
- Substance type: technical product
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): no data on presence of stabilisers
- Composition of test material, percentage of components: C10-13 chlorinated paraffin (52% chlorinated)

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:
no data

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
No data
Duration of exposure:
24 hours
Doses:
2.5 ml/kg body weight (about 2.8 g/kg bw)
No. of animals per sex per dose:
3
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: at least 7 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: signs of systemic toxicity and irritation
Statistics:
No data

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2.5 mL/kg bw
Based on:
test mat.
Remarks on result:
other: No details on sex or CLs given
Mortality:
None reported
Clinical signs:
No signs of systemic toxicity were observed
Body weight:
No data
Gross pathology:
No data
Other findings:
Slight erythema and slight desquamation were noted on days 3 and 7 after application.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No deaths or other signs of systemic toxicity were seen in groups of rats given a single dermal application of 2.5 ml/kg bw (about 2.8 g/kg bw) of a C10-13 chlorinated paraffin (52% chlorination) under an occlusive dressing for 24 h. The dermal LD50 is therefore considered to be greater than 2.5 ml/kg bw (2.8 g/kg bw).
Executive summary:

According to an expert review on SCCPs (EU, 2000), a C10-13 chlorinated paraffin (52% chlorination) was tested for acute dermal toxicity at 2.5 ml/kg bw (about 2.8 g/kg bw) in an well-conducted study. When applied undiluted, under an occlusive dressing, to groups of 3 rats for 24 h, local signs of irritation (slight erythema and slight slight desquamation) were seen at the application site at 3 and 7 days post-application. No deaths or other signs of systemic toxicity were reported in the treated rats. The acute dermal LD50 of this C10-13 chlorinated paraffin is greater than 2.5 ml/kg bw (about 2.8 g/kg bw) and therefore the test material would not be classified for acute dermal toxicity under EU CLP or DSD regulations.