2-phenylimidazole

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1977

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-phenylimidazole

EC Number:

211-581-7

EC Name:

2-phenylimidazole

Cas Number:

670-96-2

Molecular formula:

C9H8N2

IUPAC Name:

2-phenyl-1H-imidazole

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 260 g (males); 210 g (females)
- Diet: Herilan MRH-Haltung, Alleinfuttermittel für die Haltung von Mäusen, Ratten und Hamstern (Heinrich Eggersmann KG, Rinteln, Germany)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.5% aqueous CMC formulation
- Amount of vehicle: 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

Doses:

215, 316, 464, 681, 1000 and 1470 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for signs of toxicity and mortality immediately, 15 and 30 min, 1, 2, 4 and 5 h after dosing, and thereafter once daily. The body weight was recorded prior to treatment for all dose levels, and on day 3, 7 and 13 for all dose levels except of the highest dose levels.
- Necropsy of survivors performed: yes, the animals were histopathologically examined.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 1 000 mg/kg bw

Based on:

test mat.

Mortality:

1470 mg/kg bw: 5/5 males (1/5 each at 15 and 30 min post-dose, and at 2 h post-dose, respectively; and 2/5 at day 1 post-dose) and 5/5 females (3/5 at 30 min post-dose and 2/5 1 h post-dose) died
1000 mg/kg bw: 2/5 males (at day 1 post-dose) and 3/5 females (1/5 at 4-h postdose and 2/5 at day 1 post-dose) died
681 mg/kg bw: 2/5 males (1/5 each 2 h and 4 h post-dose, respectively) and 2/5 females (at 4 h post-dose) died
464 mg/kg bw: 0/5 males and 0/5 females died
316 mg/kg bw: 0/5 males and 0/5 females died
215 mg/kg bw: 0/5 males and 0/5 females died

Clinical signs:

other: 1470 mg/kg bw: distinct irregular breathing, distinct and severe apathy, distinct and severe atony, slight and distinct redness of the skin and distinct exsiccossis were observed immediately after dosage. 1000 mg/kg bw: distinct irregular breathing were o

Gross pathology:

1470 mg/kg bw: heart: dilation of the right ventricle, acute hyperemia
1000 mg/kg bw: heart: dilation of the right ventricle, acute hyperemia; liver: marbled surface, peripheral lobular pattern of the liver; stomach: atonic with substance; intestine: slightly reddened intestinal mucosa; bladder: high filling
681 mg/kg bw:without findings
464 mg/kg bw: without findings
316 mg/kg bw: without findings
215 mg/kg bw: without findings

Applicant's summary and conclusion

Interpretation of results:

other: Acute oral 4, H302 according to Regulation (EC) No. 1272/2008

Conclusions:

CLP: Acute oral 4, H302