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

Endpoint summary

Description of key information

LD50, oral, rat >200 < 500 mg/kg bw (BASF, 1997)

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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 .

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

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

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.

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

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).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Acute oral toxicity:

In a GLP compliant study (Acute toxicity - oral, EEC Directive 92/69), an acute oral toxicity study was performed. The study procedure was based on the EEC guideline and modified according to the acute toxic class method. To a group of six fasted animals (three males and three females) a single oral dose of the test material preparation in aqua bidest. at a dose level of 200 mg/kg bw was given by gavage. Another two groups each of three female animals were treated in the same way with doses of 500 and 2000 mg/kg bw.

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. 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 granular stomach, dark red discoloration of contents of the small intestine and of the caeum. No abnormalities were noted at necropsy of the male animals sacrified at the end of the study. The female sacrified animals of 200 mg/kg exhibited erosion/ulcer in the forestomach.

Under the conditions of this study the median lethal dose of2-Methylcyclohexylamine after oral application was found to be greater than 200 mg/kg bw and less or equal 500 mg/kg bw (BASF, 1997).

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data of the read-across substance 2 -Methylcyclohexylamine are reliable and suitable for classification purposes under REgulation 1272/2008. As a result the substance need to be classified and labelled as toxic after acute oral administration (GHS, cat. 3) under Regulation (EC) No 1272/2008.