Spinflam MF 83 PP-25

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Fully GLP studies. This study was performed to assess skin irritation and only few details are provided to extend the assessment to deramal toxicity

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

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

Principles of method if other than guideline:

This test was performed with the purpose of testing skin irritation/corrosion of the test item. Compared to EO Method B.3, only 500 mg of the test item was applied instead of 2000 mg. For this reason the validity of the assay is limited.

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

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.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Duration of exposure:

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

Doses:

500 mg

No. of animals per sex per dose:

3, only one sex

Control animals:

yes, concurrent no treatment

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.

Results and discussion

Effect levels

Sex:

not specified

Dose descriptor:

LD0

Effect level:

> 500 other: total quantity applied

Based on:

test mat.

Mortality:

No mortality

Clinical signs:

No clinical signs was recorded

Body weight:

No variation in body weight was recorded

Other findings:

No rabbit did show sign of toxicity

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Executive summary:

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.