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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
2003-09-26 to 2003-12-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it followed OECD guideline No. 404 and followed Good Laboratory Practice.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report Date:
2003

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
- Name of test material (as cited in study report): SARAWAX 50
- Substance type: paraffin wax
- Physical state: white waxy solid
- Analytical purity: not reported
- Impurities (identity and concentrations): not reported
- Composition of test material, percentage of components: 90 to 94%M N-alkanes, 10 to 6%M iso-alkanes
- Purity test date: not reported
- Lot/batch No.: 03/3361
- Expiration date of the lot/batch: 2006-09-01
- Stability under test conditions: stable for at least 96 hours in water vehicle
- Storage condition of test material: at room temperature in the dark

- Molecular weight (average Mn 360)
- 90 to 94% M N-alkanes, 10 to 6% M iso-alkanes
- Specific gravity 0.763 at 80 °C

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: at least 6 weeks old
- Weight at study initiation: at least 1.0 kilogram
- Housing: individually housed in cages with perforated floors
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.2 to 23.2°C
- Humidity (%): 49 to 75%
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark

IN-LIFE DATES: From: 2003-10-07 To: 2003-10-17

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
other: skin was wetted with 50% v/v ethanol/water solution before application of test material
Controls:
no
Amount / concentration applied:
0.5 grams of test substance
Duration of treatment / exposure:
4 hours
Observation period:
72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: flank
- % coverage: 2 x 3 centimetres
- Type of wrap if used: metalline patch, mounted on micropore tape, secured with Coban elastic bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): water was used to remove residual test substance
- Time after start of exposure: four hours

SCORING SYSTEM: Draize Method

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritant / corrosive response data:
Slight erythema was observed at 1 hour in the skin areas of all three rabbits but resolved by 24 hours.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, paraffin wax is considered not irritating.
Executive summary:

In a primary skin irritation study, the intact skin of three male New Zealand albino rabbits was exposed to 0.5 milligrams of paraffin wax under semi-occlusive conditions for 4 hours. Animals were observed for 72 hours, and skin irritation or corrosion was scored by the method of Draize at 1, 24, 48, and 72 hours. At the end of the 4 -hour test period, excess paraffin wax was removed with water. Slight erythema was observed at 1 hour in all three animals which was fully reversible by 24 hours. Therefore, under conditions of the study, paraffin wax is considered not irritating.

This study received a Klimisch score of 1 and is classified as reliable without restriction because it is a well-documented study report and closely followed OECD Guideline No. 404.