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Administrative data

Description of key information

Acute oral toxicity data indicate a moderate toxicity in rats with an oral LD50 of ca. 1040 mg/kg bw. The inhalation of a saturated vapour-air-mixture represents an unlikely acute hazard. In the acute dermal toxicity study a LD50 value of > 2000 mg/kg bw was determined.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
prior to OECD test guideline
Principles of method if other than guideline:
BASF-Test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
Test groups consisting of 5 animals/dose were treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals and environmental conditions:



ENVIRONMENTAL CONDITIONS
no data
Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10% solution
Doses:
0.5, 1.0 and 2.0 cm3/kg (ca. 520, 1040 and 2080 mg/kg bw)
No. of animals per sex per dose:
5 animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 5 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: body weight
Sex:
not specified
Dose descriptor:
LD50
Effect level:
ca. 1 040 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Original data: 1 cm³/kg
Mortality:
520 mg/kg bw: no animals died
1040 mg/kg bw: 2/5 animals died
2080 mg/kg bw: all animals died within 2-5 days
Clinical signs:
No unusual findings were recorded
Body weight:
Normal body weight
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
1 040 mg/kg bw
Quality of whole database:
acute oral toxicity testing similar to OECD test guideline 401

Acute toxicity: via dermal route

Link to relevant study records
Reference
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
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
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
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
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.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
2 000 mg/kg bw
Quality of whole database:
GLP compliant OECD test guideline study

Additional information

Oral toxicity

In an acute oral (gavage) toxicity study, comparable to OECD401, rats (5 animals/dose) were administered 1-vinyl-imidazole by gavage at 0.5, 1.0 and 2.0 cm3/kg (equivalent to ca. 520, 1040 and 2080 mg/kg bw) which was followed by a 5-day observation period (1953; RL2). No unusual clinical findings were recorded and normal bodyweight was observed for all animals. The LD50 was ca. 1040 mg/kg bw.

 

Inhalation toxicity

In accordance with column 2 of REACH Annex VIII, in addition to the oral route at least one other route shall be provided. As a study is available for the dermal route, a study for the inhalation route is not necessary. However, an inhalation risk test (1953; RL2) showed, that the inhalation of a saturated vapour-air-mixture represents an unlikely acute hazard.

 

Dermal toxicity

In a GLP-compliant acute dermal toxicity study, conducted according to OECD402, male and female Wistar rats (5 animals/sex) were exposed to 2000 mg/kg bw 1-vinyl-imidazole by dermal application (area of exposure: 40 cm2) for 24 hours under a semi-occlusive dressing followed by a 14 day observation period (2005; RL1). None of the animals died during the study. Clinical signs included: impaired general state, dyspnoea, lacrimation and chromodacryorrhea in both males and females. Further, red clammy snouts and eyelids and were observed from study day 1 until including study day 2 after administration in males and smeared fur was observed on females from study day 1 until including study day 2 after administration. Skin effects at the application site of 3 females 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. No macroscopic pathologic abnormalities were noted in the animals examined at termination of the study. The LD50 value was determined to be > 2000 mg/kg bw.

Justification for classification or non-classification

Based on the results of the acute oral and dermal toxicity studies, 1-vinyl-imidazole need to be classified Cat. 4; H302 according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.