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Toxicological information

Skin irritation / corrosion

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other: According to RAR (EU, 2000), this unpublished study was well reported and conducted according to modern standards.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

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.