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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:
35 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
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:
medium hazard (no threshold derived)

Additional information - workers

Worker

Acute exposure - systemic effects

It is not possible to derive a DNEL for acute effects based on the available data. There are no symptoms reported in the oral acute study at 3200 mg/kg bw. There is no risk to be expected from inhalative exposure since IRT showed no effects.

Acute exposure - local effects

Neopentylglycol is classified as "Risk of serious damage to eyes" (R41). A test was performed (as the guideline prescribes) with undiluted test substance. Therefore, this test does not provide dose-response data that could be used for the derivation of a DNEL.

It is not possible to derive a DNEL based on the available data. According to the REACH guidance on information requirements and chemical safety assessment, Part E: Risk Characterisation, a qualitative risk characterisation should be performed for this endpoint. In order to guarantee "adequately control of risks", it is necessary to stipulate risk management measures that prevent eye exposure.

Long-term exposure - systemic effects

The DNELs for inhalatory and dermal long term exposure are derived from a NOAEL of 1000 mg/kg bw obtained in an oral subchronic repeated dose toxicity study (OECD 408; BASF SE 2013).

Inhalation worker long term

Description

Value

Remark

Step 1) Relevant dose-descriptor

NOAEL: 1000 mg/kg bw (OECD 408; oral; rat)

No treatment-related, adverse findings were observed at clinical examinations, clinical pathology and pathology

Step 2) modification of the starting point

1/0.38

Route to route (8h exposure)

 

50/100

Absorption oral to inhal.

 

6.7 m³/10 m³

Correction to light work

Step 3) Assessment factors

 

 

Exposure duration

2

Subchronic to chronic

Interspecies

1

No interspecies extrapolation for inhal.

Intraspecies

5

Default assessment factor for worker; as proposed in the REACh Guidance

Remaining differences

2.5

Default assessment factor as proposed in the REACh Guidance

Dose response

1

 

Quality of database

1

 

DNEL

Value

For workers

1000 mg/kg x 0.5 x 0.67 / (0.38 x 2 x 1 x 5 x 2.5 x 1 x 1) =35 mg/m³

Dermal worker long-term

Description

Value

Remark

Step 1) Relevant dose-descriptor

NOAEL: 1000 mg/kg bw (OECD 408; oral; rat)

No treatment-related, adverse findings were observed at clinical examinations, clinical pathology and pathology

Step 2) modification of the starting point

 

 

 

1/1

Route to route

 

100/100

Absorption oral to dermal (standard)

Step 3) Assessment factors

 

 

Exposure duration

2

Subchronic to chronic

Interspecies

4

Allometric scaling from rat to human

Intraspecies

5

Default assessment factor for worker; as proposed in the REACh Guidance

Remaining differences

2.5

Default assessment factor as proposed in the REACh Guidance

Dose response

1

 

Quality of database

1

 

DNEL

Value

For workers

1000 mg/kg / (2 x 4 x 5 x 2.5 x 1 x 1) =10 mg/kg bw/d

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
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
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:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

Consumer

Acute exposure - systemic effects

It is not possible to derive a DNEL for acute effects based on the available data. There are no symptoms reported in the oral acute study at 3200 mg/kg bw. There is no risk to be expected from inhalative exposure since IRT showed no effects.

Acute exposure - local effects

Same considerations as for the worker.

Long term exposure - systemic effects

The DNELs for inhalatory and dermal long term exposure are derived from a NOAEL of 1000 mg/kg bw obtained in an oral subchronic repeated dose toxicity study (OECD 408; BASF SE 2013).

Inhalation consumer long term

Description

Value

Remark

Step 1) Relevant dose-descriptor

NOAEL: 1000 mg/kg bw (OECD 408; oral; rat)

No treatment-related, adverse findings were observed at clinical examinations, clinical pathology and pathology

Step 2) modification of the starting point

 

 

 

1/1.15

Route to route (24h exposure)

 

50/100

Absorption oral to inhal.

Step 3) Assessment factors

 

 

Exposure duration

2

Subchronic to chronic

Interspecies

1

No interspecies extrapolation for inhal.

Intraspecies

10

Default assessment factor for consumer as proposed in the REACh Guidance

Remaining differences

2.5

Default assessment factor as proposed in the REACh Guidance

Dose response

1

 

Quality of database

1

 

DNEL

Value

For consumer

1000 mg/kg x 0.5 / (1.15 x 2 x 1 x 10 x 2.5 x 1 x 1) =8.7 mg/m³

Dermal consumer long term

Description

Value

Remark

Step 1) Relevant dose-descriptor

NOAEL: 1000 mg/kg bw (OECD 408; oral; rat)

No treatment-related, adverse findings were observed at clinical examinations, clinical pathology and pathology

Step 2) modification of the starting point

 

 

 

1/1

Route to route

 

100/100

Absorption oral to dermal (standard)

Step 3) Assessment factors

 

 

Exposure duration

2

Subchronic to chronic

Interspecies

4

Allometric scaling from rat to human

Intraspecies

10

Default assessment factor for consumer as proposed in the REACh Guidance

Remaining differences

2.5

Default assessment factor as proposed in the REACh Guidance

Dose response

1

 

Quality of database

1

 

DNEL

Value

For consumer

1000 mg/kg / (2 x 4 x 10 x 2.5 x 1 x 1) =5 mg/kg bw/d

Oral consumer long term

Description

Value

Remark

Step 1) Relevant dose-descriptor

NOAEL: 1000 mg/kg bw (OECD 408; oral; rat)

No treatment-related, adverse findings were observed at clinical examinations, clinical pathology and pathology

Step 2) Assessment factors

 

 

Exposure duration

2

Subchronic to chronic

Interspecies

4

Allometric scaling from rat to human

Intraspecies

10

Default assessment factor for consumer as proposed in the REACh Guidance

Remaining differences

2.5

Default assessment factor as proposed in the REACh Guidance

Dose response

1

 

Quality of database

1

 

DNEL

Value

For consumer

1000 mg/kg / (2 x 4 x 10 x 2.5 x 1 x 1) =5 mg/kg bw/d