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Administrative data

Description of key information

Justification for selection of acute toxicity – oral endpoint
Only one study available.

Justification for selection of acute toxicity – inhalation endpoint
GLP study report available. Only one study available.

Justification for selection of acute toxicity – dermal endpoint
In accordance with column 2 of REACH Annex VIII, the testing by the dermal route is not appropriate if inhalation of the substance is likely.

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
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
No information on use of OECD and EU guidelines nor GLP conditions. The study was probably conducted according to TSCA guidelines
Test type:
standard acute method
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: feed
Vehicle:
corn oil
Doses:
1 ml per 100 g of body weight
No. of animals per sex per dose:
4 dose levels were used, and 10 males and 10 females received each dose
Sex:
male
Dose descriptor:
LD50
Effect level:
ca. 1 320 mg/kg bw
95% CL:
95
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 795 mg/kg bw
95% CL:
95

The LD50s and confidence intervals were calculated by the method of Thomson and Weil (Weil, 1952).

The effects of short-term exposure to alpha-TNT (up to 4 weeks) appear to be almost totally reversible. At the end of a 4 week period, the body weights of rats at the high dose level were still slightly lower (not significantly) than those of controls, and there were lingerinig signs of overcompensation to the anemia in females receiving 0.25% alpha-TNT. Thus at 0.05% alpha-TNT, liver-to-blood weight ratio in females remained altered (in an apparently dose-related manner) at the end of the recovery period. At 0.25% alpha-TNT, the digns of residual toxicity were clearer. At the end od the 4 week cerovery period, the body weights of females remained significantly depressed, they still had signs of anemia, and their spleens and livers remained enlarged. After the recovery period, the testes and kidney weights of males were lower than those of controls, and there was slightl granulocytosis in the males. these factors-the cumulative nature of alpha-TNT toxicity and more long-lasting effects after longer exposure periods for some parameters - are design considerations for longer term studies to assess hazards to humans.

Interpretation of results:
Category 4 based on GHS criteria
Conclusions:
Harmful if swallowed. According to Regulation (EC) No. 1272/2008 (EU CLP).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
795 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records
Reference
Endpoint:
acute toxicity: inhalation
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Species:
rat
Strain:
Crj: CD(SD)
Sex:
male/female
Route of administration:
inhalation: aerosol
Type of inhalation exposure:
nose only
Vehicle:
air
Analytical verification of test atmosphere concentrations:
no
Remarks:
The carrier air into the exposure chamber and the extraction from it was monitored visually using calibrated flow meters and recorded at approximately 30 minute intervals throughout the exposure period.
Duration of exposure:
4 h
Concentrations:
The target concentration of 1.0 mg/L was selected based on the known oral toxicity (LD50) of 2,4,6-Trinitrotoluene.
No. of animals per sex per dose:
5 males, 5 females
Control animals:
no
Key result
Sex:
male/female
Dose descriptor:
LC50
Effect level:
> 1.01 mg/L air
Based on:
test mat.
Exp. duration:
4 h
Mortality:
There was no mortality observed during the study period.
Clinical signs:
other: Slow respiration, salivation and red liquid apparent in restraint tube were noted in all animals during the 4 hour exposure. Subdued behaviour, laboured respiration, rolling gait, piloerection, unkempt coat, and red staining, abdomen were noted post expos
Body weight:
All animals’ body weight profile was satisfactory throughout the study period
Gross pathology:
No necropsy findings were noted in any animal

The following parameters and end points were evaluated in this study: clinical signs, body weights, body weight changes, and gross necropsy findings.

In conclusion, following a single 4 hour inhalation exposure to 2,4,6-Trinitrotoluene via snout only method no mortality or overt toxicity was observed during exposure or post exposure observation period. The LC50 is considered to be in excess of 1.01 mg/L.

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, following a single 4 hour inhalation exposure to 2,4,6-Trinitrotoluene via snout only method no mortality or overt toxicity was observed during exposure or post exposure observation period. The LC50 is considered to be in excess of 1.01 mg/L.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LC50
Value:
1.01 mg/m³

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because inhalation of the substance is likely
Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

According to classification criteria Regulation (EC) No. 1272/2008 (EU CLP) and LD50 values, the substance is toxic if swallowed.

According to classification criteria Regulation (EC) No. 1272/2008 (EU CLP) and LC50 values, the substance is harmful if inhaled. However, taking into consideration harmonised classification and the possible exposure to human the substance can still be classfied as toxic if inhaled.