3-methyl-1-p-tolyl-5-pyrazolone

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: Well perforemd study following scientific prinziples performed prior to GLP and OECD guideline implementation.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: company guideline similar to OECD 401

GLP compliance:

no

Remarks:

performed prior to GLP implementation

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

3-methyl-1-p-tolyl-5-pyrazolone

EC Number:

201-708-4

EC Name:

3-methyl-1-p-tolyl-5-pyrazolone

Cas Number:

86-92-0

Molecular formula:

C11H12N2O

IUPAC Name:

3-methyl-1-p-tolyl-5-pyrazolone

Test animals

Species:

rat

Strain:

other: albino

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 200 - 300 grams
- Fasting period before study: twenty-four hours
- Housing: common cage
- Diet (e.g. ad libitum): free access
- Water (e.g. ad libitum): free access

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

propylene glycol

Doses:

2000, 4000, 8000, 10000, 12500, 16000 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: daily
- Necropsy of survivors performed: No postmortem, or histopathology examinations were performe

Results and discussion

Effect levels

Effect levels 1

Sex:

male

Dose descriptor:

LD50

Effect level:

8 550 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

7 450 mg/kg bw

Based on:

test mat.

Mortality:

male

dose level / mortality

2000 mg/kg bw.: 0 of 5
4000 mg/kg bw.: 0 of 5
8000 mg/kg bw.: 2 of 5
10000 mg/kg bw.: 3 of 5
12500 mg/kg bw.: 4 of 5
16000 mg/kg bw.: 5 of 5


female

dose level / mortality

2000 mg/kg bw.: 0 of 5
4000 mg/kg bw.: 1 of 5
8000 mg/kg bw.: 2 of 5
10000 mg/kg bw.: 4 of 5
12500 mg/kg bw.: 5 of 5
16000 mg/kg bw.: 5 of 5

Clinical signs:

other: The animals dosed at levels of 2000 mg/kg bw. did not exhibit any symptoms of toxicity. At 4000 mg/kg bw. and 8000 mg/kg bw. levels, the animals were lethargic with ruffled coats after dosing. All animals dosed at 10000 mg/kg bw. and above were extremely

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

LD50 male: 8550 mg/kg bw.
LD50 female:7450 mg/kg bw.

These values are above the threshold for classification and thus do not meet criteria for classification according to REGULATION (EC) No 1272/2008.

Executive summary:

Male and female albino rats were subjected to test acute oral toxicity according to a company guideline similar to OECD 401. The test substance was administered by gavage at dose levels of 2000, 4000, 8000, 10000, 12500, 16000 mg/kg bw. (vehicle: propylene glycol). Based on the mortality rates detected LD50 values were calculated as follows:

LD50 male: 8550 mg/kg bw. LD50 female:7450 mg/kg bw.