C-C1

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29th March 2007 to 1st April 2007

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2007

Report date:

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

Remarks:

Date of inspection: 30th August 2005 Date of signature: 21st November 2005

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

Sponsor's identification: C-C1
Description : dark blue powder
Batch number : MB-1
Date received : 05 March 2007
Storage conditions: room temperature in the dark over silica gel

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: an accredited supplier
- 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: ad libitum access to Certified Rabbit Diet
- Water: ad libitum access to mains drinking water
- 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): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 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: End of study

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g of test material moistened with 0.5 ml of distilled water

Duration of treatment / exposure:

4 h

Observation period:

72 hours.

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: back of rabbit 2.5 cm x 2.5 cm
- % coverage: 100% coverage within area
- Type of wrap if used: Semi-occlusive

REMOVAL OF TEST SUBSTANCE
- Washing (if done): any residual test material removed by gentle swabbing with cotton wool soaked in distilled water at end of exposure period
- Time after start of exposure: 4 hours

SCORING SYSTEM: Classification according to the Draize scheme.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

: Animal 1

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effect produced

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

: Animal 2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effect produced

Results 3

Irritation parameter:

erythema score

Basis:

mean

Remarks:

: Animal 3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effect produced

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

: Animal 1

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effect produced

Results 5

Irritation parameter:

edema score

Basis:

mean

Remarks:

: Animal 2

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effect produced

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

: Animal 3

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

other: no effect produced

Irritant / corrosive response data:

No evidence of skin irritation was noted during the study.

Other effects:

Blue-coloured staining was noted at all treated skin sites during the study. This did not affect evaluation of skin reactions.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

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.
Classification according to Regulation (EC) No. 1272/2008 (CLP) is not required.

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 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation.

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.