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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP, however no data pertaining to individual Draize score are available (Documentation insufficient for assessment)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes
Remarks:
(Hoechst AG, Toxicology and Pathology)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Trioxane
- Physical state: crystals
- Analytical purity: 99.1%
- Impurities (identity and concentrations): ca. 0.1% Triethanolamine, ca. 0.8% water
- Storage condition of test material: 4 °C in dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Age at study initiation: ca. 3-5 months
- Weight at study initiation: 2.2-2.5 kg
- Diet (e.g. ad libitum): Altromin 2123 (ca. 15 g daily)
- Water (e.g. ad libitum): deionised water


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:
physiological saline
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg (0.2 ml of physiol. saline was used to make paste)
Duration of treatment / exposure:
4 h
Observation period:
30-60 min, 24, 48, and 72 h after removal of test substance
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- dorsal area of trunk was clipped 24h before application of test substance

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes with luke warm water
- Time after start of exposure: 4 h


Results and discussion

Any other information on results incl. tables

No irritation responses were observed, however no data pertaining to individual Draize score are available.

Applicant's summary and conclusion