[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

13 November 2007 and 16 November 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Date of inspection: August 2007; Date of certificate: October 2007

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

482-130-1

EC Name:

-

Cas Number:

848301-87-1

Molecular formula:

Main general molecular formula: CnH(2n+2)

IUPAC Name:

Paraffin waxes (Fischer-Tropsch), full range, C15-50 - branched and linear

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): Paraffin waxes (Fischer-Tropsch), full range, C15-50 - branched and linear
- Physical state: Turbid liquid
- Lot/batch No.: Not reported
- Storage condition of test material: Room temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK.
- Age at study initiation: twelve to twenty weeks old.
- Weight at study initiation: 2.0 to 3.5 kg.
- Housing:The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Free access to mains drinking water and food (Certified Rabbit Diet) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Water (e.g. ad libitum):Free access to mains drinking water and food (Certified Rabbit Diet) was allowed throughout the study. The diet and drinking water were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
- Acclimation period: Acclimatisation period of at least five days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): The rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light): the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.

IN-LIFE DATES: From:0 To:3

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): A quantity of 0.5 ml of the test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin.
- Concentration (if solution): No Data

VEHICLE
- Amount(s) applied (volume or weight with unit): Not applicable
- Concentration (if solution):Not applicable
- Lot/batch no. (if required): Not applicable
- Purity:Not applicable

Duration of treatment / exposure:

5 hours

Observation period:

Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored.

Number of animals:

Three rabbits

Details on study design:

TEST SITE
- Area of exposure: On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flank area using veterinary clippers. On the day of the test a suitable test site was selected on the back of each rabbit.
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Five hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure:Five hours after application.


SCORING SYSTEM:
EVALUATION OF SKIN REACTIONS
Erythema and Eschar Formation Value
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema 4

Oedema Formation
Value
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema (raised approximately 1 millimetre) 3
Severe oedema (raised more than 1 millimetre and extending beyond the area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

An isolated incident of very slight erythema was noted at one treated skin site at the 48-hour observation.
Two treated skin sites appeared normal throughout the study and the remaining treated skin site appeared normal at the 72-hour observation.

Any other information on results incl. tables

An isolated incident of very slight erythema was noted at one treated skin site at the 48-hour observation.

Two treated skin sites appeared normal throughout the study and the remaining treated skin site appeared normal at the 72-hour observation.

Deviation from protocol: Due to a technician error the animals were decontaminated one hour later than specified in the Protocol. This deviation was considered not to affect the purpose or integrity of the study.

Applicant's summary and conclusion

Interpretation of results:

other: EU-GHS criteria not met

Conclusions:

The test material produced a primary irritation index of 0.0 and was classified as NON IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.

Executive summary:

Introduction. The study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

§        OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted)

§        Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC

Results. A single 5-hour, semi-occluded application of the test material to the intact skin of three rabbits produced an isolated incident of very slight erythema at one treated skin site. Two treated skin sites appeared normal throughout the study and the remaining treated skin site appeared normal at the 72-hour observation.

Due to a technician error the animals were decontaminated one hour later than specified in the Protocol. This deviation was considered not to affect the purpose or integrity of the study.

Conclusion. The test material produced a primary irritation index of 0.0 and was classified as non‑irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.