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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1994
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: well performed OECD study with GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not specified
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-nitro-p-toluic acid
EC Number:
202-549-3
EC Name:
3-nitro-p-toluic acid
Cas Number:
96-98-0
Molecular formula:
C8H7NO4
IUPAC Name:
4-methyl-3-nitrobenzoic acid
Details on test material:
Purity: 99.5 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Strain: Wistar rat I Hoe: WISKf (SPF71)
- Source: HOECHST AG, Kastengrund, SPF breeding colony
- Age at study initiation: males: approx. 7 weeks; females: approx. 8 weeks
- Weight at study initiation:males: 178 - 185 g; females: 168 - 179 g
- Fasting period before study: 16 hours
- Housing: in fully air-conditioned rooms in makrolon cages (Type 4) on soft wood granulate in groups of 5 animals
- Diet: Altromin 1324 rat diet; (Altromin GmbH, Lage/Lippe), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: not necessary (breeding at identical conditions)

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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: 2% potatoe starch in deionised water
Details on oral exposure:
The animals received the compound as a 20 % suspension in 2 % starch mucilage (potatoe starch in deionised water), the application volume being
10 ml/kg body weight.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: twice a day and weighing: day 1, 8 and 15
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD0
Effect level:
2 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
no
Clinical signs:
other: No symptoms were observed after application of 2000 mg/kg body weight.
Gross pathology:
The animals killed at the end of the observation period showed no macroscopically visible changes.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 of the substance is greater than 2000 mg/kg bw; therefore no classification is required.
Executive summary:

Acute oral toxicity testing of Nitro-p-tolylsaure in the Wistar rat was tested according OECD guideline 401 only at a dose level of 2000 mg/kg body weight.

The animals received the compound as a 20 % suspension in 2 % starch mucilage (potatoe starch in deionised water), the application volume being 10 ml/kg body weight.

After application of 2000 mg/kg b.w. neither deaths nor symptoms occurred.

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