Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Currently viewing:

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: Detailed laboratory report, pre-GLP and guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
sex and strain not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3(or 4)-methylbenzene-1,2-diamine
EC Number:
248-145-0
EC Name:
3(or 4)-methylbenzene-1,2-diamine
Cas Number:
26966-75-6
Molecular formula:
C7H10N2
IUPAC Name:
3(or 4)-methylbenzene-1,2-diamine
Details on test material:
Vicinal isomer mix was maintained, prepared and extracted under a blanket on nitrogen in order that degradation would not occurr.

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
Animals weight between 200 and 300 g were fed, housed and watered according to lab SOPs.
.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
Overnight fast before dosing. Vehicle de-aerated water. Dose was 4% concentration and dosed volume adjusted to deliver the target dose.
Doses:
0, 400, 600, 640, 720, 760, 800 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
yes
Details on study design:
Animals observed for signs of toxicity and mortality at 1, 3, 6, 24, 48, 72 hours and then daily for total of 14 days.
Autopsies performed on all dead animals.
Statistics:
LD50 determinations calculated by the method of Miller and Tainter, 1944 (Exptl. Biol. and Med. 57, pp 261 - 264)

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
660 mg/kg bw
Remarks on result:
other: S.E. =19
Mortality:
No mortality at 400 mg/kg
100% mortality at 800 mg/kg
Clinical signs:
other: Decreased locomotor activity in all dosed groups in the first 24 hours after dosing Piloerection seen at 600mg/kg and above in the first 24 hours after dosing Ptosis seen at 640mg/kg and above in the first 24 hours after dosing.
Gross pathology:
Not reported
Other findings:
Not reported

Any other information on results incl. tables

Mortality

mg/kg BW dead/dosed

0 (control)      0/10

400              0/10

600              2/10

640              4/10

720              7/10

760              9/10

800              10/10

Applicant's summary and conclusion

Executive summary:

LD 50 of vicinal isomer mix was 660 +/- 19 mg/kg BW.