Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.14 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
225
Dose descriptor starting point:
LOAEL
Value:
25 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
30.86 mg/m³
Explanation for the modification of the dose descriptor starting point:

A LOAEL of 25 mg/kg bw/day was determined for the registered substance in an Extended One-Generation Reproductive Toxicity Study (EOGRTS) in rats (OECD TG 443, GLP).


This value was converted into the corrected inhalatory LOAEC taking into account the standard respiratory factor of 1/0.38 m³/kg/day, the absorption rates (based on ECHA Guidance R.8 the absorption rate of the starting route is by the factor of 2 lower than the one of the end-route in case of route to route extrapolation from oral to inhalation) and the standard respiratory volume in humans/ worker respiratory volume (6.7 m³ (8 h) / 10 m³ (8 h)) and the correction factor between human and experimental exposure conditions of workers (5 working days vs. 7 days continuous exposure) of 1.4.


 


LOAEC corrected = 25 mg/kg bw/day * 1/0.38 m³/kg/day * 0.5 * (6.7 m³/10 m³) * 1.4 = 30.86 mg/m³

AF for dose response relationship:
3
Justification:
LOAEC as starting point
AF for differences in duration of exposure:
6
Justification:
default for sub-acute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not applicable for inhalation
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default for workers
AF for the quality of the whole database:
1
Justification:
sufficient quality of the database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
3.43 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEL
Value:
1 030 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 030 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A NOAEL of >= 1030 mg/kg bw/day was determined for the registered substance in a dermal Combined Repeat Dose Rat Dermal Toxicity Study with a Reproduction/Developmental Toxicity Screening Test (OECD 422, GLP).


No modification of the starting point was necessary. Dermal absorption in rats and humans is assumed to be the same (worse case).

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default for rats
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default for workers
AF for the quality of the whole database:
1
Justification:
sufficient quality of the database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.86 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
NOAEL
Value:
1 030 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 030 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The acute DNEL can be set based on the long-term DNEL.


A NOAEL of >= 1030 mg/kg bw/day was determined for the registered substance in a dermal Combined Repeat Dose Rat Dermal Toxicity Study with a Reproduction/Developmental Toxicity Screening Test (OECD 422).


No modification of the starting point was necessary. Dermal absorption in rats and humans is assumed to be the same (worse case).

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
24.22 µg/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):
450
Dose descriptor starting point:
LOAEL
Value:
25 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
10.9 mg/m³
Explanation for the modification of the dose descriptor starting point:

A LOAEL of 25 mg/kg bw/day was determined for the registered substance in an Extended One-Generation Reproductive Toxicity Study (EOGRTS) in rats (OECD TG 443, GLP).


This value was converted into the corrected inhalatory LOAEC taking into account the standard respiratory factor of 1/1.15 m³/kg/day, the absorption rates (based on ECHA Guidance R.8 the absorption rate of the starting route is by the factor of 2 lower than the one of the end-route in case of route to route extrapolation from oral to inhalation).


 


LOAEC corrected = 25 mg/kg bw/day * 1/1.15 m³/kg/day * 0.5 = 10.9 mg/m³

AF for dose response relationship:
3
Justification:
LOAEL as starting point
AF for differences in duration of exposure:
6
Justification:
Default for sub-acute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not applicable for inhalation
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default for general population
AF for the quality of the whole database:
1
Justification:
sufficient quality of the database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
1.72 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
1 030 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 030 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A NOAEL of >= 1030 mg/kg bw/day was determined for the registered substance in a dermal Combined Repeat Dose Rat Dermal Toxicity Study with a Reproduction/Developmental Toxicity Screening Test (OECD 422, GLP).

No modification of the starting point was necessary. Dermal absorption in rats and humans is assumed to be the same (worse case).

AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
6
Justification:
Default subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default for rats
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default for workers
AF for the quality of the whole database:
1
Justification:
sufficient quality of the database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.44 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
NOAEL
Value:
1 030 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 030 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The acute DNEL can be set based on the long-term DNEL.

A NOAEL of >= 1030 mg/kg bw/day was determined for the registered substance in a dermal Combined Repeat Dose Rat Dermal Toxicity Study with a Reproduction/Developmental Toxicity Screening Test (OECD 422).

No modification of the starting point was necessary. Dermal absorption in rats and humans is assumed to be the same (worse case).

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13.89 µg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 800
Dose descriptor starting point:
LOAEL
Value:
25 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
25 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A LOAEL of 25 mg/kg bw/day was determined for the registered substance in an Extended One-Generation Reproductive Toxicity Study (EOGRTS) in rats (OECD TG 443, GLP). 


This value does not have to be corrected as the oral absorption rate of rats and humans are considered to be identical (100 % as worst-case assumption).

AF for dose response relationship:
3
Justification:
LOAEL as starting point
AF for differences in duration of exposure:
6
Justification:
default for sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default for rats
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
10
Justification:
Default for general population
AF for the quality of the whole database:
1
Justification:
sufficient quality of the database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
27.78 µg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
DNEL extrapolated from long term DNEL
Dose descriptor starting point:
LOAEL
Value:
25 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
25 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The acute DNEL can be set based on the long-term DNEL.


 


A LOAEL of 25 mg/kg bw/day was determined for the registered substance in an Extended One-Generation Reproductive Toxicity Study (EOGRTS) in rats (OECD TG 443, GLP). This value does not have to be corrected as the oral absorption rate of rats and humans are considered to be identical (100 % as worst-case assumption).

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population