4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-5-oxo-4,5-dihydro-1H-tetrazole-1-carboxamide

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

15 - 29 Nov 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted 24th February 1987

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

1

Reference substance name:

4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-5-oxo-4,5-dihydro-1H-1,2,3,4-tetrazole-1-carboxamide

EC Number:

605-140-1

Cas Number:

158237-07-1

Molecular formula:

C16H20ClN5O2

IUPAC Name:

4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-5-oxo-4,5-dihydro-1H-1,2,3,4-tetrazole-1-carboxamide

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Paderborn
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 7 - 8 weeks (males), 10 - 11 weeks (females)
- Weight at study initiation: 167 - 182 g (males); 174 - 186 g (females)
- Fasting period before study: 17 h ± 1 h
- Housing: five animals per cage in Makrolon cage type III on the first day of study, afterwards one animal per cage in Makrolon type IIa cages
- Diet: Altromin (R) 1324, ad libitum (2 h after exposure)
- Water: tap water, ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3.0
- Humidity (%): 40 - 70
- Air changes (per hr): 12 - 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: Nov 15 - Nov 29, 1994

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Cremophor EL 2% (v/v) in demineralized water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw

Doses:

5000 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: appearance and behavior were recorded several times on the day of treatment, and at least once a day thereafter, the body weights of the rats were recorded on day 1 before administration of the test substance and on day 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology

Statistics:

Mean values and standard errors were calculated.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortalities were observed.

Clinical signs:

other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

Animals sacrificed at the end of the post-treatment observation period showed no evidence of test-substance related grossly visible organ lesions.

Any other information on results incl. tables

Table 1: Summary - acute oral toxicity

Dose (mg/kg bw)	Number of animals	Mortalities/Clinical signs	LD50
5000	5 males	0	> 5000 mg/kg bw
5000	5 females	0	> 5000 mg/kg bw

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008.

Conclusions:

In this acute oral toxicity study in rats a LD50 value of > 5000 mg/kg bw was determined.