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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
49.4 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):
12.5
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
617.1 mg/m³
Explanation for the modification of the dose descriptor starting point:

Oral rat systemic NOAEL of 500 mg/kg bw derived for developmental toxicity in a study on rat according to OECD TG 414 served as the starting point for the DNEL derivation. The NOAEL was converted into inhalatory NOAEC by using the default respiratory volume for rats, assuming 50% absorption by oral route and 100% absorption by inhalation route (default procedure in case of oral-to-inhalation extrapolation). The NOAEC is additionally corrected by a factor of 1.4 to account for differences in exposure conditions (5 days/week for workers and 7 days for week for animals in the test).


corrected NOAEC = 500 mg/kg bw/d / 0.38 m3/kg bw * (6.7 m3/d / 10 m3/d) * 1.4 / (100% / 50%) = 617.1 mg/m3


The corresponding DNEL is calculated as follows:


DNEL = NOAEC(corrected)/overall AF = 617.1 mg/m3 / 12.5 = 49.4 mg/m3

AF for dose response relationship:
1
Justification:
default, NOAEL is used as starting point
AF for differences in duration of exposure:
1
Justification:
According to Ecetoc Guidance on Assessment Factors to Derive a DNEL (Technical Report No. 110)
AF for interspecies differences (allometric scaling):
1
Justification:
Already included in NOAEC calculation
AF for other interspecies differences:
2.5
Justification:
defult for remaining interspecies differences
AF for intraspecies differences:
5
Justification:
default value for workers
AF for the quality of the whole database:
1
Justification:
Guideline study under GLP
AF for remaining uncertainties:
1
Justification:
no uncertainties
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
42 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):
50
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
2 100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

It is assumed, that the dermal absorption will not be higher than the oral absorption (ECHA's Guidance R.8, v2.1, Nov 2012). Therefore, the NOAEL obtained via the oral route is regarded as a worst-case staring point to determine the dermal DNEL. This NOAEL is corrected by a factor of 1.4 to account for differences in exposure conditions (5 days/week for workers and 7 days for week for animals in the test) and by a factor of 3 taking into account that exposition occurs during working hours (8h for workers/24h for animal in the test).


DNEL = NOAEL(corrected)/overall AF = 2100 mg/kg bw/d / 50 = 42 mg/kg bw/d

AF for dose response relationship:
1
Justification:
default, starting point is a NOAEL
AF for differences in duration of exposure:
1
Justification:
according to Ecetoc Guidance on Assessment Factors to Derive a DNEL (Technical Report No. 110)
AF for interspecies differences (allometric scaling):
4
Justification:
default for rat to human
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:
Study according to guideline and in GLP
AF for remaining uncertainties:
1
Justification:
no uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

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):
25
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
217.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

Oral rat systemic NOAEL of 500 mg/kg bw derived for developmental toxicity in a study on rat according to OECD TG 414 served as the starting point for the DNEL derivation. The NOAEL was converted into inhalatory NOAEC by using the default respiratory volume for rats, assuming 50% absorption by oral route and 100% absorption by inhalation route (default procedure in case of oral-to-inhalation extrapolation). 


Corrected NOAEC = 500 mg/kg bw/d / 1.15 m3/kg bw  / (100% / 50%) = 217.4 mg/m3


The corresponding DNEL is calculated as follows:


DNEL = NOAEC(corrected)/overall AF = 217.4 mg/m3 / 25 = 8.7 mg/m3

AF for dose response relationship:
1
Justification:
default, NOAEL is used
AF for differences in duration of exposure:
1
Justification:
According to Ecetoc Guidance on Assessment Factors to Derive a DNEL (Technical Report No. 110)
AF for interspecies differences (allometric scaling):
1
Justification:
Already included in NOAEC calculation
AF for other interspecies differences:
2.5
Justification:
default for interspecies differences
AF for intraspecies differences:
10
Justification:
default value for consumer
AF for the quality of the whole database:
1
Justification:
guideline study in GLP
AF for remaining uncertainties:
1
Justification:
no uncertainties
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
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):
100
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

It is assumed, that the dermal absorption will not be higher than the oral absorption (ECHA's Guidance R.8, v2.1, Nov 2012). Therefore, the NOAEL obtained via the oral route is regarded as a worst-case staring point to determine the dermal DNEL. 


DNEL = NOAEL/overall AF = 500 mg/kg bw/d / 100 = 5.0 mg/kg bw/d

AF for dose response relationship:
1
Justification:
default. starting point is a NOAEL
AF for differences in duration of exposure:
1
Justification:
according to the Ecetoc Guidance on Assessment Factors to derive a DNEL (Technical Report N° 110)
AF for interspecies differences (allometric scaling):
4
Justification:
default for rat to human
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
10
Justification:
default for consumers
AF for the quality of the whole database:
1
Justification:
Study according to guidelines and in GLP
AF for remaining uncertainties:
1
Justification:
no uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity

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):
100
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

It is assumed, that the oral absorption in human will not be higher than the oral absorption in rats. Therefore, the NOAEL of 500 mg/kg bw obtained in a study according to OECD TG 414 via the oral route is regarded as a starting point to determine the oral DNEL.


DNEL = NOAEL/overall AF = 500 mg/kg bw/d / 100 =  5.0 mg/kg bw/d

AF for dose response relationship:
1
Justification:
default, starting point is a NOAEL
AF for differences in duration of exposure:
1
Justification:
according to Ecetoc Guidance on Assessment Factors to derive a DNEL (Technical Report N° 110)
AF for interspecies differences (allometric scaling):
4
Justification:
default for rat to human
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
10
Justification:
default for consumers
AF for the quality of the whole database:
1
Justification:
guideline study in GLP
AF for remaining uncertainties:
1
Justification:
no uncertainties
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population