4-(3-methyl-5-oxo-2-pyrazolin-1-yl)benzenesulphonic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Test performed before GLP guideline implementation. Important aspects (e.g. 14 day-postobservation time) very similar to OECD TG 401.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Company guideline similar to OECD 401

Deviations:

no

GLP compliance:

no

Remarks:

previous to GLP implementation

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-(3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl)benzene-1-sulfonic acid

EC Number:

201-901-3

Cas Number:

89-36-1

Molecular formula:

C10H10N2O4S

IUPAC Name:

4-(3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl)benzene-1-sulfonic acid

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain specifics: Hoe: WISKf (SPF71)
- Source: Hoechst AG, breeding colony, SPF-breed
- Weight at study initiation: female 160 g - 174 g (mean 164.7 g)
- Fasting period before study: approximately 16 hours before until 2 hours after application, access to water permitted
- Housing: in plastic cages with standard softwood bedding
- Diet (e.g. ad libitum): standard rat diet (Altromin 1324®) ad libitum
- Water (e.g. ad libitum): tap water in plastic bottles ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: 2 % starch mucilage

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25 % (w/v) suspension

Doses:

5 000 mg/kg bw

No. of animals per sex per dose:

10 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

- no deaths occurred

Clinical signs:

other: the following symptoms were noted 2 to 5 hours p.a.: stupor, cowering or crawling posture, coat bristling, flankes pinched in, orange urine discolouration

Gross pathology:

No macroscopic findings at scheduled necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Single application of 5 000 mg test item per kg bw did not cause lethality in female rats during the 14 days observation period, resulting in a LD50 > 5 000 mg/kg bw.

Executive summary:

Female rats were subjected to test acute oral toxicity according to a protocol similar to OECD TG 401 (limit test). The test item was administered at the dose level of 5 000 mg/kg bw to10 female rats. During the 14 days observation period no mortality was observed and there were no abnormalities found at necropsy, thus leading to an LD50 > 5 000 mg/kg bw.

Therefore, the test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.