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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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 levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
8 550 mg/kg bw
Based on:
test mat.
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.