Registration Dossier

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A well-conducted study, considered adequate for assessment, on a related material

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1971
Reference Type:
secondary source
Title:
Unnamed
Year:
2000

Materials and methods

Principles of method if other than guideline:
A C10-13 chlorinated paraffin (52% chlorinated) 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:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): C10-13 chlorinated paraffin (52% chlorinated)
- Molecular formula (if other than submission substance): CxH(2x-y+2)Cly, where x=10-13 and y=1-13
- 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.
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 informationCriteria 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% chlorinated) under an occlusive dressing for 24 h. The dermal LD50 is therefore greater than 2.5 ml/kg bw (2.8 g/kg bw).
Executive summary:

According to an expert review on SCCPs (EU, 2000), citing an unpublished study report, 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 and DSD regulations.

In view of the similarities in structure and physiochemical properties [between SCCPs and MCCPs], together with the low acute oral toxicities of MCCPs and their very low degree of dermal absorption, it can be predicted that MCCPs would also be of low acute toxicity by the dermal route of exposure.