Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
49.3 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Value:
1 230 mg/m³
Explanation for the modification of the dose descriptor starting point:

No inhalatory study available - Oral read across study used for route to route extrapolation

AF for dose response relationship:
1
Justification:
Corrected NOEC
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic default
AF for interspecies differences (allometric scaling):
1
Justification:
Route-route concentration, no allometric scaling required
AF for other interspecies differences:
2.5
Justification:
Default for interspecies variability - remaining differences in case of no other specific susceptibility differences info available.
AF for intraspecies differences:
5
Justification:
Assessment factor for workers
AF for the quality of the whole database:
1
Justification:
Data available on target substance
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:
14 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Value:
1 400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No dermal study available - Oral read across study used for route to route extrapolation

AF for dose response relationship:
1
Justification:
Corrected NOEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic default
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for study animal rats.
AF for other interspecies differences:
2.5
Justification:
Default for interspecies variability - remaining differences in case of no other specific susceptibility differences info available.
AF for intraspecies differences:
5
Justification:
Worker default
AF for the quality of the whole database:
1
Justification:
Data available on target substance
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

Long-term systemic inhalatory NOEC calculated based on the oral repeat dose NOAEL value as described in the guidance R.8 example B.3. The above factors were used to calculate a DNEL of 49.3 mg/m³.

Long-term systemic dermal NOEL calculated based on the oral repeat dose NOAEL value as described in Guidance R.8 . The above factors were used to calculate a DNEL of 14 mg/kg bw/day.

The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long-term DNELs are considered sufficient to ensure acute effects do not occur.

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:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Value:
435 mg/m³
Explanation for the modification of the dose descriptor starting point:

No inhalatory study available - Oral read across study used for route to route extrapolation

AF for dose response relationship:
1
Justification:
Corrected NOEC
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic default
AF for interspecies differences (allometric scaling):
1
Justification:
Route-route concentration - No allometric scaling required
AF for other interspecies differences:
2.5
Justification:
Default for interspecies variability - remaining differences in case of no other specific susceptibility differences info available.
AF for intraspecies differences:
10
Justification:
General population default
AF for the quality of the whole database:
1
Justification:
Data available on target substance
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The material is not classified for acute systemic effects, therefore derivation of acute DNEL is not required. Long-term DNELs are considered sufficient to ensure acute effects do not occur.

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:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No dermal study available - Oral read across study used for route to route extrapolation

AF for dose response relationship:
1
Justification:
Corrected NOEC
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default for study animal rats.
AF for other interspecies differences:
2.5
Justification:
Default for interspecies variability - remaining differences in case of no other specific susceptibility differences info available.
AF for intraspecies differences:
10
Justification:
Default value for general population
AF for the quality of the whole database:
1
Justification:
Data available on target susbtance
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:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route to route extrapolation necessary as is oral study.

AF for dose response relationship:
1
Justification:
Default for NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for study animal rats.
AF for other interspecies differences:
2.5
Justification:
Default for interspecies variability - remaining differences in case of no other specific susceptibility differences info available.
AF for intraspecies differences:
10
Justification:
General population default
AF for the quality of the whole database:
1
Justification:
Data available on target substance
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

Long-term systemic inhalatory NOEC calculated based on the oral repeat dose NOAEL value as described in guidance R.8. The above factors were used to calculate a DNEL of 8.7 mg/m3.

Long-term systemic dermal NOEL calculated based on the oral repeat dose NOAEL value as described in guidance R.8. The above factors were used to calculate a DNEL of 5 mg/kg bw/day.

Long-term systemic oral NOEL provided by a developmental toxicity / teratogenicity study on the test substance was used to calculate the DNEL using the above assessment factors. The DNEL was 5 mg/kg bw/day.

No local effects were observed and therefore no DNEL derived.

The material is not classified for acute systemic effects, therefore derivation of acute DNELs is not required. Long-term DNELs are considered sufficient to ensure effects do not occur.