Reaction mass of Fatty acids, montan-wax and Montan wax

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

18 FEB 1997 to 21 FEB 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (EU B4/OECD 404)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1997

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

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

- Name of test material (as cited in study report): Hoechst Wachs E
- Substance type: light yellow substance
- Physical state: solid
- Storage condition of test material: darkness at room temperature in a fume cupboard

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Thomae, Biberach, Germany
- Age at study initiation:
- Weight at study initiation: 2.4-3.1 kg
- Housing: individually
- Diet: ssniff K-H (V2333) ad libitum)
- Water: ad libitum
- Acclimation period: 1 week under study conditions


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: polyethylene glycol 400

Controls:

no

Amount / concentration applied:

The animals were treated with 0.5 g of the test substance pasted in 0.3 ml of polyethylene glycol 400.

Duration of treatment / exposure:

4 h

Observation period:

30-60 min, 24, 48, 72 h after removal of the test substance

Number of animals:

3

Details on study design:

The test item was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch an a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 - 48 - 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed at any time point

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 48 - 72 h

Score:

0

Max. score:

4

Reversibility:

other: no effects observed at any time point

Any other information on results incl. tables

All animals did not show sings of irritation at every time point of observation.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP regulation

Conclusions:

The test substance, pasted in polyethylene glycol 400, was not irritating to the skin of rabbits.

Executive summary:

Three rabbits were dermally exposed to 0.5 g of the test substance (Hoechst Wachs E, semiocclusive), pasted in polyethylene glycol 400 for 4 h. After removal of the test substance the exposed area was evaluated up to 72 h. There were no signs of irritation in all animals.