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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1986
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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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)
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.