Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 18 FEB 1997 to 21 FEB 1997
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (EU B4/OECD 404). For justification of read-across within the category please see chapter 1 of the Chemical Safety Report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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

Resultsopen allclose all
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
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: EU
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.