Spinflam MF 83 PP-25

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test conducted according to internationally accepted testing procedures and according to the GLP.

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:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Conelli snc, via Milano 61, 28041 Arona (NO), Italy.
- Age at study initiation: 8 - 9 weeks old.
- Weight at study initiation: 2 - 2.3 kg
- Diet: ad libitum.
- Water: ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 19 ± 2 °C
- Humidity: 55 %
- Air changes: 15-20 per hr.
- Photoperiod: 12 hrs dark / 12 hrs light.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 500 mg

Duration of treatment / exposure:

First rabbit: first patch 3 minutes, second patch 1 hour, third patch 4 hours.
Two other rabbits: 4 hours.

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm^2
- Type of wrap if used: the application area was covered with gauze patch loosely held in contact with the skin by an impermeable, non irritant, hypoallergenic tape (occlusive patch).

ADMINISTRATION
Up to three test patches were applied sequentially to the first animal. The first patch is removed after three minutes. Because no serious skin reaction was observed, a second patch was applied at a different site and removed after one hour. The observations at this stage indicated that exposure can humanely be allowed to extend to four hours, thus a third patch was applied and removed after four hours.
Neither a corrosive effect nor a severe irritant effect was observed after four hours exposure, therefore the test was completed using additional animals, each with one patch only, for an exposure period of four hours.

REMOVAL OF TEST SUBSTANCE
After removal, residual substance was wiped off.

SCORING SYSTEM
All animals were examined for signs of erythema and oedema, and the responses scored at 60 minutes, and then at 24, 48 and 72 hours after patch removal. For the initial test in one animal, the test site is also examined immediately after the patch has been removed (3 minutes and 1 hours, respectively.

Erythema and Eschar Formation
No erythema: 0
Very slight erythema (barely perceptible): 1
Well defined erythema: 2
Moderate to severe erythema: 3
Severe erythema (beef redness) to slight eschar formation (injuries in depth): 4
Maximum possible: 4

Oedema Formation
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 mm): 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure): 4
Maximum possible: 4

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72

Score:

ca. 2.3

Reversibility:

fully reversible

Irritant / corrosive response data:

No changes were seen at any test article application site.
The mean value is less than 2.3 for erythema/eschar and for oedema in all the tested animals, from gradings at 24, 48 and 72 hours after patch removal.

Other effects:

Neither mortality nor adverse general clinical modifications were seen during the study. No changes were seen at any test article application site.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information according to the CLP Regulation Criteria used for interpretation of results: OECD GHS

Conclusions:

not irritating

Executive summary:

Acute dermal irritation study in the New Zealand White rabbit (3 animals) was performed according to the OECD guideline 404.

0.5 g of the test article were placed on the skin of the trunk and covered with the occlusive patch.

Up to three test patches were applied sequentially to a first rabbit. The first patch is removed after three minutes. Because no serious skin reaction was observed, a second patch was applied at a different site and removed after one hour. The observations at this stage indicated that exposure can humanely be allowed to extend to four hours, thus a third patch was applied and removed after four hours. Neither a corrosive effect nor a severe irritant effect was observed after four hours exposure, therefore the test was completed using additional animals, each with one patch only, for an exposure period of four hours.

No clinical signs, either general or local (at the application sites) were noted in any rabbit.

Conclusion

The mean value is less than 2.3 for erythema/eschar and for oedema in all the tested animals, from gradings at 24, 48 and 72 hours after patch removal. In conclusion, the substance is not classify as skin irritant, according to the CLP Regulation (EC 1272/2008).