Blue MGi 1037-Na (notification presscake)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

5 June 2000 - 8 June 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: EEC Directive 2004/73, B.4

Version / remarks:

1992

GLP compliance:

yes

Test material

Test material information

Constituent 1

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Elevage Scientifique des Dombes, France
- Age at study initiation: 14 weeks
- Weight at study initiation: 3-3.2 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum, pelleted standard Provimi Kliba 3418 rabbit maintenance diet
- Water: ad libitum, tap water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30-70
- Air changes (per hr): 10-15
- 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(s) applied: 500 mg

Duration of treatment / exposure:

4 h

Observation period:

1, 24, 48, 72 hours after patch removal

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: left flank
- coverage: 6 cm2
- Type of wrap: semi-occlusive dressing and tape

REMOVAL OF TEST SUBSTANCE
- Washing: water
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
1, 24, 48, 72 hours

SCORING SYSTEM:
- Method of calculation: Draize

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of all animals. No erythema formation were observed.

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of all animals. No edema formation were observed.

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

IRRITATION:
The test item did not elicit any skin reactions at the application site.

COLORATION/CORROSION:
Light blue staining was observed in all animals after removal of the dressing and during the whole study period.
Neither alterations of the treated skin were observed nor were corrosive effects evident on the skin.

Other effects:

VIABILITY/MORTALITY/CLINICAL SIGNS:
No clinical signs of systemic toxicity were noted and no mortality occurred.

BODY WEIGHTS:
The body weights of all rabbits were within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The structual analogue BLUE MGi 1037 is considered to be not irritating to rabbit skin.

Executive summary:

The primary skin irritation potential of the structural analogue substance BLUE MGi 1037 was investigated by topical semi-occlusive application of 0.5 g to 6 cm2 intact left flank of each of three young adult New Zealand White rabbits. The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion.

The primary irritation score was calculated by totaling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of data points. The primary irritation score was 0.00 (max. 8.0).

Very slight erythema was observed in one male animal (no. 91) one hour after treatment. Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 oedema.

Light blue staining produced by the test item of the treated skin was observed in all animals after removal of the dressing and during the whole study period. No corrosive effects were noted on the treated skin of any animal at any measuring interval.

Based upon the referred classification criteria (EEC Commission Directive 93/21 /EEC of April 27, 1993), BLUE MGi 1037 is considered to be "not irritating" to rabbit skin.