Alkanes, C14-17, chloro

Acute Toxicity: dermal

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

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1971

Reference 2

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

Test material information

Constituent 1

Reference substance name:

short-chain chlorinated paraffins

IUPAC Name:

short-chain chlorinated paraffins

Constituent 2

Reference substance name:

85535-84-8

Cas Number:

85535-84-8

IUPAC Name:

85535-84-8

Constituent 3

Reference substance name:

Alkanes, C10-13, chloro

EC Number:

287-476-5

EC Name:

Alkanes, C10-13, chloro

IUPAC Name:

287-476-5

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 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.

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 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.