Alkanes, C14-17, chloro

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: cited in draft RAR (EU, 2008) as performed according to OECD Guidelines

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1986

Reference 2

Reference Type:

secondary source

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

use of occlusive rather than semi-occlusive conditions and shaved rather than closely clipped skin.

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Alkanes, C14-17, chloro

EC Number:

287-477-0

EC Name:

Alkanes, C14-17, chloro

Cas Number:

85535-85-9

Molecular formula:

Substance is a range of chlorinated isomers of C14 to C17 paraffin

IUPAC Name:

Alkanes, C14-17, chloro

Details on test material:

- Name of test material (as cited in study report): Chloroparaffin 52G
- Substance type: technical product
- Physical state: liquid
- Analytical purity: no data
- Impurities (identity and concentrations): epoxy stabiliser B74 (1%)
- Composition of test material, percentage of components: C14-17 chlorinated n-paraffin (52% chlorinated).

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

no data

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

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

Duration of treatment / exposure:

4 hours

Observation period:

up to 14 days after application

Number of animals:

6

Details on study design:

no data

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72 h

Score:

1.3

Max. score:

4

Reversibility:

no data

Remarks on result:

other: C14-17 chlorinated paraffin (52% chlorinated)

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72 h

Score:

0.3

Max. score:

4

Reversibility:

no data

Remarks on result:

other: C14-17 chlorinated paraffin (52% chlorinated)

Irritant / corrosive response data:

no data

Other effects:

Scales were seen on the 6th to 10th day after exposure.

Applicant's summary and conclusion

Interpretation of results:

slightly irritating

Remarks:

Migrated informationCriteria used for interpretation of results: other: expert judgement

Conclusions:

No corrosion was seen to the skin of rabbits treated with a single dermal application (4 h) of Chloroparaffin 52G (a C14-17 chlorinated paraffin; 52% chlorination, containing 1% epoxy stabiliser) under occlusive conditions. Only mild irritation was seen, characterised by slight erythema and slight oedema, at 24-72 h. Scales were seen on the treated skin between 6 and 10 days after application.

Executive summary:

Chloroparaffin 52G (a C14-17 chlorinated paraffin; 52% chlorinated, containing 1% epoxy stabliser B74), was applied undiluted to the shaved skin of a group of 6 rabbits under occlusive conditions (0.5 ml for 4 h). Observation of the skin was continued for up to 14 days.

Erythema and oedema were seen on the treated skin at 24 to 72 h (mean score 1.3 and 0.3 respectively) and scales were found on the skin on days 6 to 10 after exposure. No corrosion was seen.

Under the conditions of this study, the test material is considered to cause slight skin irritation to rabbits on single exposure.