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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
4-(methylamino)-3-nitrobenzoic acid
EC Number:
609-904-5
Cas Number:
41263-74-5
Molecular formula:
C8 H8 N2 O4
IUPAC Name:
4-(methylamino)-3-nitrobenzoic acid

Test animals

Species:
rat
Strain:
other: Wistar Han
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Hydroxyethylcellulose (Natrosol 25)
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 males and 3 females
Control animals:
not specified

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Under the present test conditions, a single oral administration of 2000 mg CDBA007- OZW/kg b.w. to rats caused reduced motility, ataxia, dyspnoea, reduced muscle tone, abdominal or lateral position. The animals gained the expected body weight throughout the whole study period. No mortality occurred.

No autopsy findings were noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to the EC-Commission directive 67/548/EEC and its subsequent am endments on the approximation of the laws, regulations and
administrative provision relating to the classification, packaging and labelling of dangerous substances and the results obtained under the present
test conditions CDBA0070ZW batch no. T20103 requires no classification (as LD50 > 2000 mg/kg).