Alkanes, C10-13, chloro

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: According to RAR (EU, 2000), this unpublished study was well reported and conducted according to modern standards.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

2000

Materials and methods

Principles of method if other than guideline:

Dermal irritation potential of a C10-13 chlorinated paraffin (59% chlorination) assessed in rabbits.

GLP compliance:

not specified

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 (59% chlorination)
- Substance type: technical product
- Physical state: liquid
- Analytical purity: not specified
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: C10-13 chlorinated paraffin (59% chlorination)
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 h

Observation period:

up to 72 h

Number of animals:

3, sex unspecified

Details on study design:

TEST SITE
- Area of exposure: no data
- % coverage: no data
- Type of wrap if used: no data

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance removed but washing not specified
- Time after start of exposure: 4 h

SCORING SYSTEM: not specified

Results and discussion

In vivo

Irritant / corrosive response data:

No signs of irritation.

Other effects:

None reported.

Any other information on results incl. tables

No irritation scores provided in expert review (EU, 2000)

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

In a well reported, unpublished study conducted according to modern standards, no dermal irritation was seen for up to 72 h following a 4 h (semi-occlusive) application of undiluted C10-13 chlorinated paraffin (59% chlorination) to the skin of three rabbits.

Executive summary:

In a well reported, unpublished study conducted according to modern standards, three rabbits were treated, dermally, with 0.5 ml of undiluted C10-13 chlorinated paraffin (59% chlorination), applied under a semi-occlusive dressing to the shaven skin for 4 h. The skin was examined for signs of irritation for up to 72 h after removal of the test substance. There were no signs of dermal irritation throughout the test period.