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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
other information
Study period:
data not available
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment

Data source

Reference
Reference Type:
publication
Title:
DNA-damaging activity in vivo and bacterial mutagenicity of sixteen aromatic amines and azo-derivatives, as related quantitatively to their carcinogenicity
Author:
Parodi S, Taningher M, Russo P, Pala M, Tamaro M & Monti-Bragadin C
Year:
1981
Bibliographic source:
Carcinogenesis 2 (12): 1317-26

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The substance was administered intraperitonealy to a group of experimental animals at one of the defined doses, a series of doses increasing serially by a constant factor usually < 2.
GLP compliance:
no
Limit test:
no

Test material

Constituent 1
Reference substance name:
98-80-7
IUPAC Name:
98-80-7
Constituent 2
Chemical structure
Reference substance name:
4-methyl-m-phenylenediamine
EC Number:
202-453-1
EC Name:
4-methyl-m-phenylenediamine
Cas Number:
95-80-7
Molecular formula:
C7H10N2
IUPAC Name:
4-methylbenzene-1,3-diamine
Details on test material:
- Name of test material (as cited in study report): 2,4-Diaminotoluene from E. Merck, Darmstadt,GFR.
- Analytical purity: 96%
- Molecular Weight: 122.19
No other data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals or test system and environmental conditions:
Data not available

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Details on exposure:
None
Doses:
A series of doses increasing serially by a constant factor usually < 2 was used.
No. of animals per sex per dose:
4 males per dose levels
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 5 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no
- Other examinations performed: none
Statistics:
The LD50 was calculated according to the method of Weil (1952), only after the doses given were sufficient to obtain both 0% and 100% mortality.

Weil C.S. 1952. Tables for convenient calculation of median effective dose (LD50 or ED50) and instructions in their use. Biometrics, 8, 249-263.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
147 mg/kg bw
Mortality:
no data
Clinical signs:
no data
Body weight:
no data
Gross pathology:
no data
Other findings:
None

Applicant's summary and conclusion

Conclusions:
Under the conditions of this test, LD50 is 147 mg/kg bw.
Executive summary:

Parodi at al.(1981) investigated to demonstrated for sixteen compounds a qualitative correlation with carcinogenic activity and induction of DNA damage in mamalian cells or bacterial mutagenicity. The dose level to be used in in vivo genotoxicity assay was selected from known LD50. As no data was available in litterature for 2,4 -Toluendiamine, an acute toxicity was performed. Male Sprague-Dawley rats (4 animals for each dose) were administered i.p. a series of doses of 2,4 -toluendiamine increasing serially by a constant factor. The LD50 at 5 days was calculated according to the method of Weil (1951), only after the doses given were sufficient to obtain both 0% and 100 % mortality. No data on mortality, clinical signs, body weight, or gross pathology were reported. The obtained LD50 is 147 mg/kg bw. Because of documentation insufficient for assessment, this data was classified unreliable.