1-vinylimidazole

Acute Toxicity: dermal

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 guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-vinylimidazole

EC Number:

214-012-0

EC Name:

1-vinylimidazole

Cas Number:

1072-63-5

Molecular formula:

C5H6N2

IUPAC Name:

1-ethenyl-1H-imidazole

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 or test system 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:

other: 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 an

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (5 males and 5 females) examined at termination of the study.