Registration Dossier

Toxicological information

Acute Toxicity: inhalation

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Administrative data

Endpoint:
acute toxicity: inhalation
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study meets generally accepted scientific principles (IHT; restriction: purity unknown, limited documentation, no determination of test atmosphere concentration). 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:
Inhalation hazard test: to evaluate the acute inhalation toxicity, group of male Carworth-Wistar rats were exposed for 8 hours to an atmosphere saturated with vapours of the test substance and observed 14 days for mortality.
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: Sherman
Sex:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: usually 100-150 g


ENVIRONMENTAL CONDITIONS
not reported

Administration / exposure

Route of administration:
inhalation: vapour
Type of inhalation exposure:
whole body
Vehicle:
air
Details on inhalation exposure:
GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Sealed chamber
- Exposure chamber volume: 120-liter
- Method of holding animals in test chamber: Six rats are rapidly introduced by means of a drawer-type cage designed to minimize vapor loss.
- Source and rate of air: For inhalation periods of ten, five and two minutes in duration, a static technique is used whereby 50 to 100 grams of material, spread over a shallow tray 200 square inches in area, is placed in a 120-liter sealed chamber for at least 24 hours.
- Method of conditioning air: The vapor-air mixture is generated by passing 2.5 liters/minute of dried air at room temperature through a fritted glass disc immersed to a depth of at least one inch in approximately 50 ml of the test chemical contained in a gas-washing bottle.
The exposure apparatus is described in sufficient detail in Smyth et al. 1949, "Assay for Acute Vapor Toxicity".
Analytical verification of test atmosphere concentrations:
no
Duration of exposure:
8 h
Concentrations:
Not determined (IHT)
No. of animals per sex per dose:
6
Control animals:
not specified
Details on study design:
Animals were weighed prior to exposure and at the end of the post-exposure 14-day observation interval. Animals were observed for signs of toxicity during and after the exposure interval, and daily during the 14-day postexposure observation interval.
Autopsies are performed on all of the rats to ascertain that they did not die of extraneous infection. Gross pathologic change is recorded and liver, spleen, adrenal gland, kidney, and testis are taken for histopathological interpretation from 2 of the rats which died during the 14 day observation period and also from 2 that survived. The survivors are weighed and killed by transecting the spinal cord in the cervical region. An attempt is made to take the tissues for histopathological study from rats exposed to the concentration which killed either 2, 3, or 4 of the 6 exposed.
Statistics:
The LC50 value was calculated ex post with a probit analysis according to Finney.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LC50
Based on:
test mat.
Exp. duration:
8 h
Remarks on result:
other: No death occurred when the test animals were exposed to an atmosphere saturated with vapours of test substance (IHT)
Mortality:
No death occurred
Clinical signs:
other: Not reported in the publication.
Body weight:
Not reported in the publication.
Gross pathology:
Not reported in the publication.

Applicant's summary and conclusion