Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
8002-74-2
Cas Number:
8002-74-2
IUPAC Name:
8002-74-2
Constituent 2
Reference substance name:
paraffin wax
IUPAC Name:
paraffin wax
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 or test system 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.