Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Isodur
- Physical state: solid
- Analytical purity: 90.3 %
- Lot/batch No.: 1/08
- Stability under test conditions: The stability of the test substance under storage conditions over the test period was guaranteed by the sponsor, and
the sponsor holds this responsibility.
- Storage condition of test material: Room temperature/ dry storage
- Other:

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Wiga GmbH
- Age at study initiation: male animals approx. 8 - 9 weeks, female animals approx. 12 - 13 weeks
- Weight at study initiation: males: 232-255 g; females: 206-224 g
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22-26 °C
- Humidity (%): 20-80 %
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
CMC (carboxymethyl cellulose)
Details on dermal exposure:
TEST SITE
- Area of exposure: About 40 cm² (corresponds to at least 10% of the body surface)
- % coverage: at least 10 % of the body
- Type of wrap if used: semi-occlusive dressing (the bandage consists of four layers absorbent gauze, Ph. Eur. Lohmann GmbH & Co. KG
and Fixomull stretch (adhesive fleece), Beiersdorf AG)


REMOVAL OF TEST SUBSTANCE
- Washing (if done): Rinsing of the application site with warm water.
- Time after start of exposure: after 24 hours of exposure


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 g/kg (50% testsubstance)
- Concentration (if solution): 50 g/100 ml
- Constant volume or concentration used: yes
- For solids, paste formed: yes
Duration of exposure:
24 hours
Doses:
2000 mg/kg
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation. Recording of signs and symptoms several times on the day of application, at least once each workday for the individual animals
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,gross pathology, assessment of the skin reactions
Statistics:
not applicable

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
No mortality occurred
Clinical signs:
No systemic clinical observations were observed during clinical examination and no local effects (skin) were observed
Body weight:
The mean body weights of the animals increased normally throughout the study period
Gross pathology:
No macroscopic pathologic findings were noted in the animals (5 males and 5 females) examined on the last day of observation

Applicant's summary and conclusion