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Toxicological information

Acute Toxicity: dermal

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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:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material: 1-Vinylimidazol
- Substance No.: 00/0335-2
- Physical state: liquid
- Analytical purity: 99.8 %
- Lot/batch No.: 19812968E0
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor
- Storage condition of test material: room temperature

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: RCC Ltd. (Wölferstrasse 4, 4414 Füllinsdorf, Switzerland)
- Age at study initiation: young adult animals (males ca. 8-10 weeks, females ca. 12-14 weeks)
- Weight at study initiation: males: 233-247 g, females: 224-228 g
- Housing: individually in stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: Kliba-Labordiät, Maus / Ratte Haltung "GLP" (Provimi Kliba SA, Kaiseraugst, Basel, Switzerland), ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Air changes (per hr): the animals were housed in fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal and dorsolateral parts of the trunk
- % coverage: about 40 cm2 (corresponds to at least 10% of the body surface)
- Type of wrap if used: four layers absorbent gauze (Ph . Eur. Lohmann GmbH & Co . KG) and Fixomull stretch (adhesive fleece) (Beiersdorf AG)

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


TEST MATERIAL
- Amount applied: 1.92 ml/kg bw (2000 mg/kg bw)
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes, concurrent no treatment
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations: at least once daily; weighing: shortly before application, weekly thereafter and at the end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None of the animals died during the 14-day observation period.
Clinical signs:
Males: Impaired general state, dyspnoea, lacrimation, chromodacryorrhea and red clammy snout and eyelid were observed from study day 1 until including study day 2 after administration.
Females: impaired general state, dyspnoea, smeared fur, lacrimation and chromodacryorrhea were observed from study day 1 until including study day 2 after administration. Skin effects at the application site of 3 animals comprised very slight and well defined erythema, scaling and superficial scabbing and were observed from study day 3 until including study day 10 after administration.
Body weight:
The mean body weights of the animals increased throughout the study period.
Gross pathology:
No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined at termination of the study.

Applicant's summary and conclusion