diethyl 1-(2,4-dichlorophenyl)-5-methyl-4,5-dihydro-1H-pyrazole-3,5-dicarboxylate

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:

1990

Report date:

1990

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EPA OPP 81-2 (Acute Dermal Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

diethyl 1-(2,4-dichlorophenyl)-5-methyl-4,5-dihydro-1H-pyrazole-3,5-dicarboxylate

EC Number:

603-923-2

Cas Number:

135590-91-9

Molecular formula:

C16H18Cl2N2O4

IUPAC Name:

diethyl 1-(2,4-dichlorophenyl)-5-methyl-4,5-dihydro-1H-pyrazole-3,5-dicarboxylate

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Age at study initiation: males approx. 8 weeks, females approx. 9 weeks
- Weight at study initiation: males 221 g mean, females 193 g mean
- Fasting period before study:
- Housing: in fully air-conditioned rooms in Makrolon cages (Type 3) on soft wood granulate, one animal per cage
- Diet (e.g. ad libitum): Altromin 1324 rat diet (Altromin GmbH, Lage/Lippe), ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 50±20
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: sesame oil

Details on dermal exposure:

TEST SITE
- Area of exposure: 30 cm².
- Type of wrap if used: The treated skin area was covered with an aluminium foil (6x8 cm), which was held in place with an elastic plaster bandage fixed around the animal's body (Fixomull, and ElastoplastR , 8 cm in width, both manufactured by Beiersdorf).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): warm water
- Time after start of exposure: 24 h


TEST MATERIAL
- Constant volume or concentration used: yes
- For solids, paste formed: yes


VEHICLE
- Amount(s) applied (volume or weight with unit): preparation of 1 g test substance per 0.67 ml vehicle

Duration of exposure:

24 hours

Doses:

4000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: observations twice daily until d6, thereafter once daily, weighing weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 4 000 mg/kg bw

Based on:

test mat.

Mortality:

During the 15-day observation period, no mortality occurred among either males or females following treatment with 4000 mg/kg bw.

Clinical signs:

other: The clinical signs of intoxication indicated no sex-specific differences. The clinical signs began to emerge 1 day after administration and persisted in some cases up to day 6 of the study. Clinical signs such as irregular breathing and squatting position

Gross pathology:

The animals killed at the end of the observation period were free of macroscopically visible changes.

Other findings:

- Other observations: Signs of skin irritation such as dry and rough skin surface covered with fine scales were observed in most of the animals. They emerged on day 4 and persisted in some cases up to day 8 of the study.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

CLP: Not classified