Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen, deaminated

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Remarks:

THE STUDY PROCEDURE WAS BASED ON THE EEC GUIDELINE AND MODIFIED ACCORDING TO THE ACUTE TOXIC CLASS METHOD .

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

THE STUDY PROCEDURE WAS BASED ON THE EEC GUIDELINE AND MODIFIED ACCORDING TO THE
ACUTE TOXIC CLASS METHOD .

Deviations:

yes

Remarks:

males and females were tested

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

2-methylcyclohexylamine

EC Number:

230-277-5

EC Name:

2-methylcyclohexylamine

Cas Number:

7003-32-9

Molecular formula:

C7H15N

IUPAC Name:

2-methylcyclohexanamine

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

animal species : rat / wistar / chbb : thom (spf)
animal breeder: dr. k . thomae gmbh, biberach, frg
age of the animals: young adult animals
animal weights at start of the study: animals of comparable weight ; (150g - 300g) (+/- 20x of the mean weight)
animal identification : individual identification using cage cards and group identification by tail marking .
room temperature: the animals were housed in fully air-conditioned rooms. central air-conditioning guaranteed a range
of 20 - 24 degrees celsius for temperature and of 30 - 70 % for relative humidity .

day/night rhythm: 12 h/12 h (6 .00 a .m . - 6 .00 p .m ./ 6 .00 p .m . - 6 .00 a .m . )
type of cage : stainless steel wire mesh cages, type dk-iii (becker & co ., castrop-rauxel, frg )
no . of animals per cage : single housing .
bedding : no bedding in the cages ; sawdust in the waste trays .
drinking water : tap water ad libitum per day .
diet: ad libitum

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

single oral administration by gavage

Doses:

DOSE NO 1: 200 mg/kg
DOSE NO 2: 500 mg/kg
DOSE NO 3: 2000 mg/kg

No. of animals per sex per dose:

3

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days (Dose 1, 200 mg/kg)
- Frequency of observations and weighing: individual body weights shortly before application (day 0), weekly thereafter and at the end of the study (before fasting period)
- Necropsy of survivors performed: yes at the last day of the observation period. withdrawal of food at least 16 hours before killing with c02 ; then necropsy with grosspathology examination. necropsy of all animals that died before as early as possible.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 200 - < 500 mg/kg bw

Based on:

test mat.

Mortality:

All animals of the 2000 and 500 mg/kg dose group died 1 hour after application .
No mortality occurred in the 200 mg/kg dose group .

Clinical signs:

Signs of toxicity noted in the 2000 and 500 mg/kg dose group:
- comprised poor general state, dyspnoea, apathy, lateral position, staggering, atonia, paresis, twitching, extention spasm, salivation and lacrimation .

The animals of the 200 mg/kg dose group showed impaired or poor general state, dyspnoea, apathy, excitation, staggering, ataxia, tremor, twitching, spastic
gait and chromodacryorrhea .

The surviving animals appeared normal within 2 days after application .

Body weight:

The expected body weight gain was observed in the course of the study .

Gross pathology:

Necropsy findings of the animals that died comprised dark red discoloration of
the glandular stomach and the forestomach, erythema of the forestomach, erosion
in the glandular stomach, dark red discoloration of contents of the small
intestines and of the caecum .
The female sacrificed animals (200 mg/kg dose group) exhibited erosions/ulcer in the forestomach .
No abnormalities were noted at necropsy of the male animals sacrificed at the
end of the study

Applicant's summary and conclusion

Interpretation of results:

Category 3 based on GHS criteria

Conclusions:

Under the conditions of this study the median lethal dose of 2-methylcyclohexylamin after oral application was found to be greater than 200 mg/kg and less or equal 500 mg/kg body weight .

Executive summary:

Based on the results observed and by applying the evaluation criteria it was concluded that Reaction product of 2,4-Dinitrotoluene and 2,6-Dinitrotoluene and hydrogen, deaminated needs to be classified as toxic after single application (GHS cat. 3, H301).