Alkanes, C10-13, chloro

Acute Toxicity: dermal

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1971

Reference 2

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

Test material information

Constituent 1

Reference substance name:

Alkanes, C10-13, chloro

EC Number:

287-476-5

EC Name:

Alkanes, C10-13, chloro

Cas Number:

85535-84-8

IUPAC Name:

Alkanes, C10-C13, Chloro

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 or test system 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:

other: No signs of systemic toxicity were observed

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.