Registration Dossier

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

Constituent 1
Chemical structure
Reference substance name:
4-(3-methyl-5-oxo-2-pyrazolin-1-yl)benzenesulphonic acid
EC Number:
201-901-3
EC Name:
4-(3-methyl-5-oxo-2-pyrazolin-1-yl)benzenesulphonic acid
Cas Number:
89-36-1
Molecular formula:
C10H10N2O4S
IUPAC Name:
4-(3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl)benzenesulfonic 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:
the following symptoms were noted 2 to 5 hours p.a.: stupor, cowering or crawling posture, coat bristling, flankes pinched in, orange urine discolouration
Body weight:
body weight increase was not impaired
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.