Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.994 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEC
Value:
419.632 mg/m³
AF for intraspecies differences:
5
Justification:
worker default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.967 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
60
Modified dose descriptor starting point:
NOAEL
Value:
238 mg/kg bw/day
AF for intraspecies differences:
5
Justification:
worker default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Toxicokinetics:

Fish were exposed for seven days in a flow-through system to a mixture of trichloro aniline. The fish showed no noticeable deviations from ordinary swimming or eating behaviour, either during exposure, or elimination. This study provides evidence that trichloro anilines can be acetylated by the guppy. The observed differences in biotransformation of the TCA isomers appears to be dependent upon the substitution pattern within the molecule. Substitution at both ortho-positions, such as in 246TCA, may give rise to steric hindrance, which may result in a substantial decrease of biotransformation rate. Elimination of chemicals by fish is, in general, inversely related to the compounds hydrophobicity. The elimination rate constant for 2,4,6, TCA determined in this study was slightly higher. The elimination rate constants of 2,4,6-trichloroaniline, the isomer with the highest BCF value, were equal to the calculated elimination rate constants indicating that biotransformation does not influence the elimination of these compounds. Biotransformation products for these compounds were not detected.

Acute Toxicity (Oral, Dermal, Inhalation):

Based upon the study results and available information, the substance 2,4,6-trichloroaniline (CAS No 634-93-5) is expected to show acute toxicity effect by the oral route for category IV as per CLP classification, while the dermal and inhalation route qualify and thus will not be considered for further classification.

Irritation effect (Skin & Eye):

On the basis of available information, the substance 2,4,6-trichloroaniline is likely to be irritating to skin but not in eyes of animals and is therefore the chemical is classified as "Irritating to skin" as per the CLP criteria.

Skin sensitization:

The chemical 2,4,6-trichloroaniline is likely to be "sensitizing" to the skin of guinea pig and mice as per the available experimental data and predicted data using QSAR. Thus, the chemical is classified as being "sensitizing"

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.725 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEC
Value:
206.957 mg/m³
AF for intraspecies differences:
10
Justification:
general population default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.983 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Value:
238 mg/kg bw/day
AF for intraspecies differences:
10
Justification:
General population default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.992 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Value:
119 mg/kg bw/day
AF for intraspecies differences:
10
Justification:
general population default
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

DNEL derivation

2,4,6-trichloroanilineexhibits acute toxicity by oral route of exposureand thus will be considered in acute toxic category for classification.

2,4,6-trichloroanilinewas found to be irritating to skin, thus leading to a conclusion that the target will be irritant to skin.  Available studies also indicate that the chemical does not exhibit genotoxicity and is not a reproductive toxin within the dose levels mentioned in the end points  

In the absence of local effects following short-term or long-term exposure, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for local exposure are therefore not calculated.   In the absence of acute systemic toxicity, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for acute systemic effects are therefore not calculated.  

A standard approach to deriving DNEL values would be to use the reproductive dose toxicity dataset and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the NOAEL of 476 mg/kg bw/d in oral category.