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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14.6 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
24
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
350 mg/m³
Explanation for the modification of the dose descriptor starting point:

The relevant endpoint is the NOAEL of 100 mg/kg bw/d from the 90-day oral rat study with TMP; no treatment-related adverse effects were seen at this dose level.

Following the default assumption that inhalation absorption is twice oral absorption, an equivalent inhalation NOAEL of 50 mg/kg bw/d is derived. This is equivalent to 350 mg/m3(assuming 70 kg bodyweight and a breathing rate of 1.25 m3/h, 8h/day).

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:
4.2 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
24
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The relevant endpoint is the NOAEL of 100 mg/kg bw/d from the 90-day oral rat study with TMP; no treatment-related adverse effects were seen at this dose level.

Following the default (worst case) assumption that dermal absorption will not exceed oral absorption, an equivalent dermal NOAEL of 100 mg/kg bw/d is derived.

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:
low hazard (no threshold derived)

Additional information - workers

Identity of the substance and approach to meeting the data requirements

The substance Polyol TD consists of three components:

CTF (5 -ethyl-1,3 -dioxane-5 -methanol)

DMP (2-ethylpropane-1,3-diol)

TMP (propylidynetrimethanol)

The relevant toxicological data requirements are met by a combination of data for Polyol TD and data for the individual components. The components DMP and TMP are considered to be sufficiently similar for read-across to be appropriate. Therefore, for each relevant data requirement, data are provided for Polyol TD or DMP/TMP and CTF.

DNEL derivation:

Based on the available data, the substance is of low acute toxicity, is not a skin irritant or sensitiser and is not mutagenic, a developmental or reproductive toxin. Classification is proposed for eye irritation (Cat.2, H319) based on data for the component CTF.

The relevant NOAEL for DNEL derivation is the NOAEL of 100 mg/kg bw/d from a 90-day oral repeated dose study with the Polyol TD component TMP in rats. No treatment-related adverse effects were seen at this dose level.

TMP is driving classification of the substance Polyol TD and therefore, the NOAEL from a subchronic oral repeated dose toxicity study with TMP was used for DNEL calculation. This can be considered as a conservative approach.

This assumption and any implications for the derivation of the DNEL values will be re-assessed when the results from the 90-day repeated dose and prenatal developmental toxicity studies are available.

Local effects

DNEL values for local effects are not derived. The substance is not a skin irritant or sensitiser but is an eye irritant. However, relevant dose-response data are not available and a quantitative dose descriptor cannot be determined. Exposure should be avoided by the use of appropriate protective equipment.

Systemic effects

The substance is of low systemic toxicity. No acute toxicity hazard resulting in classification has been identified, therefore a DNEL for acute systemic effects is not proposed.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
175 mg/m³
Explanation for the modification of the dose descriptor starting point:

The relevant endpoint is the NOAEL of 100 mg/kg bw/d from the 90-day oral rat study with TMP; no treatment-related adverse effects were seen at this dose level.

Following the default assumption that inhalation absorption is twice oral absorption, an equivalent inhalation NOAEL of 50 mg/kg bw/d is derived. This is equivalent to 175 mg/m3 (assuming 70 kg bodyweight and a breathing rate of 20 m3/day).

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:
2.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The relevant endpoint is the NOAEL of 100 mg/kg bw/d from the 90-day oral rat study with TMP; no treatment-related adverse effects were seen at this dose level.

Following the default (worst case) assumption that dermal absorption will not exceed oral absorption, an equivalent dermal NOAEL of 100 mg/kg bw/d is derived.

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:
2.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The relevant endpoint is the NOAEL of 100 mg/kg bw/d from the 90-day oral rat study with TMP; no treatment-related adverse effects were seen at this dose level.

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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

Identity of the substance and approach to meeting the data requirements

The substance Polyol TD consists of three components:

CTF (5 -ethyl-1,3 -dioxane-5 -methanol)

DMP (2-ethylpropane-1,3-diol)

TMP (propylidynetrimethanol)

The relevant toxicological data requirements are met by a combination of data for Polyol TD and data for the individual components. The components DMP and TMP are considered to be sufficiently similar for read-across to be appropriate. Therefore, for each relevant data requirement, data are provided for Polyol TD or DMP/TMP and CTF.

DNEL derivation:

Based on the available data, the substance is of low acute toxicity, is not a skin irritant or sensitiser and is not mutagenic, a developmental or reproductive toxin. Classification is proposed for eye irritation (Cat.2, H319) based on data for the component CTF.

The relevant NOAEL for DNEL derivation is the NOAEL of 100 mg/kg bw/d from a 90-day oral repeated dose study with the Polyol TD component TMP in rats. No treatment-related adverse effects were seen at this dose level.

TMP is driving classification of the substance Polyol TD and therefore, the NOAEL from a subchronic oral repeated dose toxicity study with TMP was used for DNEL calculation. This can be considered as a conservative approach.

This assumption and any implications for the derivation of the DNEL values will be re-assessed when the results from the 90-day repeated dose and prenatal developmental toxicity studies are available.

Local effects

DNEL values for local effects are not derived. The substance is not a skin irritant or sensitiser but is an eye irritant. However, relevant dose-response data are not available and a quantitative dose descriptor cannot be determined. Exposure should be avoided by the use of appropriate protective equipment.

Systemic effects

The substance is of low systemic toxicity. No acute toxicity hazard resulting in classification has been identified, therefore a DNEL for acute systemic effects is not proposed.

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