Registration Dossier

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

Reference
Name:
Unnamed
Type:
Constituent
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 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:
Not reported in the publication.
Body weight:
Not reported in the publication.
Gross pathology:
Not reported in the publication.

Applicant's summary and conclusion