Registration Dossier
Registration Dossier
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EC number: 204-781-0 | CAS number: 126-30-7
Toxicological Summary
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 |
|
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