[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:

28 Jan - 06 Feb 2009

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

Commission Directive 2004/73/EC

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

THE DEPARTMENT OF HEALTH OF THE GOVERNMENT OF THE UNITED KINGDOM, UK GLP Monitoring Authority

Test material

Test material information

Constituent 1

Reference substance name:

Vapour grown graphitic carbon fibre

Molecular formula:

C

IUPAC Name:

Vapour grown graphitic carbon fibre

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Limited, Bicester, UK
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation (kg): 2.42 - 2.82
- Housing: Individually in suspended cages provided with environmental enrichment items
- Diet: Free access to food (2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, UK)
- Water: Free access to mains drinking water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g moistened with 0.5 mL distilled water

Duration of treatment / exposure:

Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h

Observation period:

Initial and confirmatory tests: 72 h
Reading time points: 1, 24, 48 and 72 h

Number of animals:

Initial test: 1 male
Confirmatory test: 2 males

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm on the dorsal/flank area
- Type of wrap if used: Cotton gauze patch secured with a strip of surgical adhesive tape. The trunk was wrapped in an elasticated corset for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing: Residual test material was removed·by gentle swabbing with cotton wool soaked in distilled water.

OBSERVATION TIME POINTS
1, 24, 48 and 72 h after removal of patches

SCORING SYSTEM:
Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

other: mean of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Results 2

Irritation parameter:

edema score

Basis:

other: mean of 3 animals

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: reversibility not applicable

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study in any animal. Individual erythema and edema scores were 0.0 for all animals at all observation time points. Black coloured staining was noted throughout the study.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.

Conclusions:

The test material produced no evidence of skin irritation to the intact skin of rabbits and was thus considered non-irritating.