Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study meets generally accepted scientific principles (restriction: purity unknown, limited documentation). The registered substance is a reaction product of 2,4-dinitrotoluene and 2,6-dinitrotoluene and hydrogen (common name: diaminomethylcyclohexane or MDACH, respectively) consisting of the two isomers 4 -methylcyclohexane-1,3-diamine (CAS 13897-55-7; molecular weight approx. 128 g/mol) and 2-methylcyclohexane-1,3-diamine (CAS 13897-56-8; molecular weight approx. 128 g/mol). The registered substance was tested in several toxicity studies, which were conducted on the one hand using 4-methylcyclohexane-1,3-diamine (CAS 13897-55-7) which is the main isomer of the registered substance (up to 90%) and on the other hand the reaction product of 2,4-dinitrotoluene and 2,6-dinitrotoluene and hydrogen was tested as such (for details see read across justification, IUCLID chapter 13).

Data source

Reference
Reference Type:
publication
Title:
Range-Finding Toxicity Data: List VII
Author:
Smyth HF, Carpenter CP, Weil CS, Pozzani UC, Striegel JA, Nycum JS
Year:
1969
Bibliographic source:
Am. Ind. Hyg. Assoc. J. 30: 470-476

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Estimation of single oral dose toxicity of the test substance by the gastric intubation of groups of male rats.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
4-methylcyclohexane-1,3-diamine
EC Number:
237-666-9
EC Name:
4-methylcyclohexane-1,3-diamine
Cas Number:
13897-55-7
Molecular formula:
C7H16N2
IUPAC Name:
4-methylcyclohexane-1,3-diamine
Details on test material:
- Name of test material (as cited in study report): 2,4-diamino-1-methylcyclohehexane
No additional details provided

Test animals

Species:
rat
Strain:
other: Carworth-Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: own breeding
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 90-120 g
- Fasting period before study: no
- Diet (e.g. ad libitum): Rockland rat diet


ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
not specified: water or corn oil
Details on oral exposure:
VEHICLE
No further information provided.
Doses:
No data
No. of animals per sex per dose:
5
Control animals:
not specified
Details on study design:
Animals were observed for signs of toxicity after dosing, and throughout the 14-day observation interval. Animals were weighed prior to dosing and at the end of the observation interval. Animals that died on study were subjected to necropsy; surviving animals were sacrificed at the end of the observation interval and necropsied.
Statistics:
Thompson's method of calculating the LD50 was applied to the 14-day mortality data.

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 1 276.1 mg/kg bw
Based on:
test mat.
Remarks on result:
other: corresponding to a LD50 of 1.41 mL, calculated with a density of 0.905 g/mL as prefered result of the OECD SIDS
Mortality:
Not reported in the publication.
Clinical signs:
other: Not reported in the publication.
Gross pathology:
Not reported in the publication.

Applicant's summary and conclusion