Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Chloroparaffin 40G
- 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 paraffin (40% chlorinated)

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
no data

Test system

Type of coverage:
occlusive
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
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:
1.5
Max. score:
4
Reversibility:
no data
Remarks on result:
other: C14-17 chlorinated paraffin (40% chlorinated)
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24-72 h
Score:
0.6
Max. score:
4
Reversibility:
no data
Remarks on result:
other: C14-17 chlorinated paraffin (40% chlorinated)
Irritant / corrosive response data:
no data
Other effects:
Scales were seen on the 6th to 10th days after exposure, preceded by drying and hardness of the skin at 72 hours. Peeling was observed on days 6 to 8.

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 (4 h) application of Chloroparaffin 40G (a C14-17 chlorinated paraffin; 40% chlorination, containing 1% epoxy stabiliser) under occlusive conditions. Only mild irritation was seen, characterised by slight erythema and slight oedema at 24-72 h, drying and hardness at 72 h, peeling of presumably the outermost layers of the skin on days 6 to 8 and the presence of scales on days 6 to 10 after application.
Executive summary:

Chloroparaffin 40G (a C14-17 chlorinated n-paraffin, 40% chlorinated; containing 1% epoxy stabiliser 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 1.5 and 0.6 respectively) and "dryness and hardness" noted at 72 h. Peeling, presumably of the outermost layers of the skin, was seen at days 6 to 8 and scales were seen on the skin on days 6 to 10. 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.