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:
10.858 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:
651.487 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:
6.158 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:
369.5 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 :

The REACH regulation mentions the following for toxicokinetics: Assessment of the toxicokinetic behaviour of the substance needs to be done to the extent that can be derived from the relevant available information. It is important to note that Iscotrizinol (USAN], Synonym (diethylhexyl butamido triazone) is an organic compound predominantly used in sunscreens to absorb UVA and UVB radiations.

Thus, the oral ingestion, distribution, metabolism and excretion of the chemical is unlikely. For dermal absorption, certain European studies conducted to review the dermal absorption potential indicate very low degree of percutaneous absorption when the radioactive form of the chemical was used on living human skin samples (ex-vivo).

Analysis of the other toxicity data in the review study conducted on Iscotrizinol led to the conclusion that the compound exhibited a sufficiently high margin of safety. Thus, the end point of toxico-kinetics was considered for waiver since it can be concluded that the bio-accumulation potential for this chemical is low considering the low dermal absortion and the very low likelihood of oral absorption of the test chemical.

Skin & eye irritation :

Available data indicates that the chemical Bis(2-ethylhexyl) 4,4’-{6-[4-tert-butylcarbamoyl)anilino]-1,3,5-triazine-2,4-diyldiimino}dibenzoate is not likely to have acute toxicity effects by the oral, inhlation and dermal route of exposure. Thus, the chemical is not classified for acute toxicity by any of the three routes of exposure.

Skin sensitizer :

The chemical bis(2-ethylhexyl) 4,4’-{6-[4-tert-butylcarbamoyl) anilino]-1,3,5-triazine-2,4-diyldiimino}dibenzoate is classified as Non-sensitizing based upon the maximization test conducted in rabbits.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.678 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:
321.304 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:
3.079 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:
369.5 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:
1.54 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:
184.75 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

(Bis(2-ethylhexyl) 4,4’-{6-[4-tert-butylcarbamoyl)anilino]-1,3,5-triazine-2,4-diyldiimino} dibenzoate) do not exhibit acute toxicity by inhalation, oral and dermal route of exposure and so will not be considered in acute toxic category for classification.

(Bis(2-ethylhexyl) 4,4’-{6-[4-tert-butylcarbamoyl)anilino]-1,3,5-triazine-2,4-diyldiimino} dibenzoate) was not found to be irritating to skin and eye, thus leading to a conclusion that the target will be non-irritant to skin as well as eye.  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 toxicity dataset and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the NOAEL of 739 mg/kg bw/d in oral category.

Categories Display