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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
NOAEC

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:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
NOAEL

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

For the purposes of determining a Derived No Effect Level, a conservative approach is taken in which, as a worst case, the 2-year NOAEL >200 mg/kg/ day is used to represent the toxicity of the whole substance for repeated dose systemic toxicity in all cases. In the absence of any findings indicative of reproductive or developmental effects for any of the substances tested, DNELs for these endpoints cannot be quantified. No short-term peak exposures to DTO are expected under normal conditions of use, so long-term DNELs are also protective for short-term exposures. The substance is not classified as skin irritant, eye irritant or sensitising.

The oral route is not considered for workers, since oral exposure will not occur during normal handling and use of DTO.

Table 5.16: Corrected dose descriptor(s) per endpoint and endpoint-specific DNEL(s)/DMEL(s) for workers

Endpoint

Route

Most relevant quantitative dose descriptor (appropriate unit)

Corrected dose descriptor (appropriate unit)

Overall AF applied

Endpoint-specific DNEL/DMEL

(appropriate unit)

Local

Systemic

Local

Systemic

Local

Systemic

Repeated dose toxicity sub-acute/ sub-chronic/ chronic

oral

NA

NOAEL >200 mg/kg/d

NA

NOAEL >50 mg/kg/d

NA

NA

NA

dermal

NA

No data

NA

NOAEL >50 mg/kg/d

5

NA

>10 mg/kg/d

inhalation

NA

No data

NA

NOAEC >177 mg/m3

5

NA

>35.3 mg/m3

Table 5.17: DN(M)ELs for workers

Exposure pattern

Route

Descriptors

DNEL

Most sensitive endpoint

Acute - systemic effects

Dermal

Not quantifiable

-

No effects

Inhalation

Not quantifiable

-

No effects

Oral

Not quantifiable

-

No effects

Acute - local effects

Dermal

Not quantifiable

 

No effects

Inhalation

Not quantifiable

-

No effects

Long-term - systemic effects

Dermal

DNEL

>10 mg/kg/d

Repeated-dose toxicity

Inhalation

DNEL

>35.3 mg/m3

Repeated-dose toxicity

Long-term – local effects

Dermal

Not quantifiable

-

No effects

Inhalation

Not quantifiable

-

No effects

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC

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:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL

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:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

For the purposes of determining a Derived No Effect Level, a conservative approach is taken in which, as a worst case, the 2-year NOAEL >200 mg/kg/ day is used to represent the toxicity of the whole substance for repeated dose systemic toxicity. In the absence of any findings indicative of reproductive or developmental effects, DNELs for these endpoints cannot be quantified.

 

No short-term peak exposures to DTO are expected under normal conditions of use, so long-term DNELs are also protective for short-term exposures.

 

DTO does not have any local irritant effects and is not a skin sensitiser.

DTO is not classified for acute toxicity, irritation, sensitisation, repeated-dose toxicity, carcinogenicity, mutagenicity, reproductive or developmental toxicity. Findings in repeated-dose dietary studies in rats were minor and related mainly to unpalatability of the test diet, rather than showing evidence of systemic toxicity. However, the available data have been used to determine indicative long-term DNEL values, as a worst-case.There were no effects for reproductive or developmental endpoints; therefore it is not possible to quantify DNELs for reproductive or developmental toxicity.

Table 5.18: DN(M)ELs for the general population

Exposure pattern

Route

Descriptors

DNEL/DMEL (appropriate unit)

Most sensitive endpoint

Acute - systemic effects

Dermal

Not quantifiable

-

No effects

Inhalation

Not quantifiable

-

No effects

Oral

Not quantifiable

-

No effects

Acute - local effects

Dermal

Not quantifiable

-

No effects

Inhalation

Not quantifiable

-

No effects

Long-term - systemic effects

dermal

DNEL

>5 mg/kg/d

Repeated-dose toxicity

Inhalation

DNEL

>8.7 mg/m3

Repeated-dose toxicity

oral

DNEL

>5 mg/kg/d

Repeated-dose toxicity

Long-term – local effects

Dermal (mg/cm2)

Not quantifiable

-

No effects

Inhalation (mg/m3)

Not quantifiable

-

No effects