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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: only males and only 3 doses used instead of 5 as required.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1980

Materials and methods

Principles of method if other than guideline:
Method: other:
3 doses tested, 10 male animals/dose, single dose by gavage, observation period up to 14 d.
A range finding study was conducted to determine the initial dose.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
m-toluidine
EC Number:
203-583-1
EC Name:
m-toluidine
Cas Number:
108-44-1
Molecular formula:
C7H9N
IUPAC Name:
3-methylaniline
Test material form:
other: liquid
Details on test material:
IUCLID4 Test substance: other TS: m-toluidine, purity >98.5%

Test animals

Species:
rat
Strain:
Crj: CD(SD)
Sex:
male
Details on test animals or test system and environmental conditions:
young adult males, no further data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
single oral application by gavage
Doses:
700, 1000, 1350 mg/kg bw diluted in corn oil
No. of animals per sex per dose:
10
Control animals:
not specified
Details on study design:
The range-finding study was run with 1 rat per dose for levels of 100-3500 mg/kg bw and produced death at 1500 mg/kg bw and above.
Main study:
Single oral application by gavage to 10 male rats and observation for 14 days. The surviving rats were weighed and observed during a 14-day recovery period and then sacrificed. The LD50 value was calculated from the mortality data using probit analysis of DJ Finney, 1971, Cambridge University Press.
Statistics:
Probit analylysis

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
922 mg/kg bw
95% CL:
>= 792 - <= 1 054
Remarks on result:
other: clinical signs included lacrimation, stained face, chromodacryorrhea, stained and wet perineal area, cyanosis, moribundity and moderate weight loss
Mortality:
1350 mg/kg bw: 10/10 all deaths occurred wintin 2 days after dosing
1000 mg/kg bw 6/10 all deaths occurred within 3 days after dosing
700 mg/kg bw 1/10 death occurred 2 days after dosing
Clinical signs:
other: 1350 mg/kg bw: lacrimation, chromodacryorrhea, cyanosis, moribundity and weight loss 1000 mg/kg bw lacrimation, chromodacryorrhea, cyanosis, labored breathing, diarrhea, stained and wet perineal area, stained face, weakness, moribunditss, and moderate
Gross pathology:
no data
Other findings:
no data

Any other information on results incl. tables

No further data.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Executive summary:

Oral application of 1350 -700 mg/kg bw m-toluidine diluted in corn oil to male rats resulted in a LD50 value of 922 mg/kg bw (DuPont De Nemours 1980). Clinical signs observed at most dose levels included lacrimation, stained face, chromodacryorrhea, stained and wet perineal areas, cyanosis, morbundity and moderate weight loss. All deaths occurred within 3 days after dosing.

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