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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

8 - 22 November 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

adopted 9 October 2017

Deviations:

yes

Remarks:

exposure under occlusive conditions, exposure of males and females

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: Pesticide Assessment Guidelines, Subdivision F, Hazard Evaluation: Human and Domestic Animals, Series 81-2 Acute Dermal Toxicity Study

Version / remarks:

November 1984

Test guideline 3

Qualifier:

according to guideline

Guideline:

other: Annex V, Part B.3. (acute toxicity [dermal]) to Directive 67/548/EEC of the Council of the European Communities in its current version as amended for the seventeenth time by Directive 92/69/EEC of the Commission of the European Communities

Version / remarks:

31 July 1992

GLP compliance:

yes

Test type:

fixed dose procedure

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

Remarks:

Hsd Win:WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, District of Paderborn, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: 10 - 12 weeks (males), > 16 weeks (females)
- Weight at study initiation: 262 - 298 g (males), 229 - 242 g (females)
- Housing: 5 animals in Makrolon cages type III during the acclimation period, individually in type IIA cages during test period
- Diet: Altromin® 1324 diet, ad libitum
- 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

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: Natriumchlorid (NaCl)

Details on dermal exposure:

TEST SITE
- Area of exposure: 5 x 5 cm²
- Type of wrap if used: foil (fermoflex), occlusive dressing

REMOVAL OF TEST SUBSTANCE
- Washing: cleaned with soap and water
- Time after start of exposure: 24 h

TEST MATERIAL
- Amounts applied: 5000 mg/kg bw (43.3-49.3 mg/cm², males and 37.9 - 40.0 mg/cm² females)
- For solids, paste formed: yes

VEHICLE
- Amount applied: 1.5 ml NaCl solution/g test substance
- Concentration (if solution): 0.9%

Duration of exposure:

24 h

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Appearance and behavior was recorded several times on the day of treatment, and at least once a day thereafter, and individual body weights were determined on Day 1 before administration and on Day 8 and 15
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology examination

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 up to the end of the 14-day observation period.

Clinical signs:

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

Gross pathology:

Necropsy and histopathological examination revealed no substance-related findings.

Any other information on results incl. tables

Table 1: Body weights [g]

Animal number	Sex	Day 1	Day 8	Day 15
1	male	287	305	336
2	male	298	321	254
3	male	272	292	323
4	male	276	307	341
5	male	262	281	308
Mean		279 ± 13.9	301 ±15.3	332 ± 17.6
1	female	241	233	233
2	female	229	228	234
3	female	235	239	244
4	female	240	241	246
5	female	242	231	240
Mean		237 ± 5.4	234 ± 5.5	239 ± 5.8

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

CLP: not classified