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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.322 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:
75 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
66.118 mg/m³
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation is needed. Experimental rat oral NOAEL was converted into human inhalatory NOAEC considering: the "8h exposure rat standard Respiratory Volume" (0.38 m3/kg); the "rat oral absorption"/"human inhalatory absorption" ratio (50/100); the "8h human standard Respiratory Volume"/"8h worker  Respiratory volume" ratio (6.7 m3/10 m3).

AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is a NOAEL (as mentioned in ECHA Guidance R8 v2.1, november 2012).
AF for differences in duration of exposure:
1
Justification:
an AF for exposure duration is not necessary provided that the experimental exposure adequately covered the pregnancy of the species under investigation (as mentioned in ECETOC TR 110, 2010)
AF for interspecies differences (allometric scaling):
4
Justification:
An AS factor of 4 for rat as compared to humans is mentioned in ECHA Guidance R8 v2.1, november 2012.
AF for other interspecies differences:
2.5
Justification:
Default factor mentioned in ECHA Guidance R8 v2.1, november 2012
AF for intraspecies differences:
5
Justification:
As mentioned in ECHA Guidance R8 v2.1, november 2012: "For workers, as standard procedure for threshold effects a default assessment factor of 5 is to be used, based on the fact that this sub population does not cover the very young, the very old, and the very ill".
AF for the quality of the whole database:
1
Justification:
The starting study has been performed according to OECD TG 414 and GLP studies (Klimisch code 1)
AF for remaining uncertainties:
1
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:
1.5 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):
50
Dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation is not needed: on the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation (as mentioned in ECHA Guidance R8 v2.1, november 2012).

AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is a NOAEL (as mentioned in ECHA Guidance R8 v2.1, november 2012).
AF for differences in duration of exposure:
1
Justification:
an AF for exposure duration is not necessary provided that the experimental exposure adequately covered the pregnancy of the species under investigation (as mentioned in ECETOC TR 110, 2010). Interspecies extrapolation and other interspecies differences: 10 (as 4 * 2.5) – after allometric scaling for caloric demand a factor of 10 is proposed for the NOAEL obtained by prenatal toxicity studies (as mentioned in ECETOC TR 110, 2010)
AF for interspecies differences (allometric scaling):
4
Justification:
An AS factor of 4 for rat as compared to humans is mentioned in ECHA Guidance R8 v2.1, november 2012
AF for other interspecies differences:
2.5
Justification:
Default factor mentioned in ECHA Guidance R8 v2.1, november 2012
AF for intraspecies differences:
5
Justification:
As mentioned in ECHA Guidance R8 v2.1, november 2012: "For workers, as standard procedure for threshold effects a default assessment factor of 5 is to be used, based on the fact that this sub population does not cover the very young, the very old, and the very ill".
AF for the quality of the whole database:
1
Justification:
- The starting study has been performed according to OECD TG 414 and GLP (Klimisch code 1)
AF for remaining uncertainties:
1
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:
low 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:
0.326 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):
100
Dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
32.609 mg/m³
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation is needed. Experimental rat oral dev NOAEL was converted into human inhalation NOAEC considering: the "24h exposure rat standard Respiratory Volume" (1.15 m3/kg); the "rat oral absorption"/"human inhalatory absorption" ratio (50/100).

AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is a NOAEL (as mentioned in ECHA Guidance R8 v2.1, november 2012).
AF for differences in duration of exposure:
1
Justification:
an AF for exposure duration is not necessary provided that the experimental exposure adequately covered the pregnancy of the species under investigation (as mentioned in ECETOC TR 110, 2010, p62)
AF for interspecies differences (allometric scaling):
4
Justification:
An AS factor of 4 for rat as compared to humans is mentioned in ECHA Guidance R8 v2.1, november 2012.
AF for other interspecies differences:
2.5
Justification:
Default factor as mentioned in ECHA Guidance R8 v2.1, november 2012
AF for intraspecies differences:
10
Justification:
As mentioned in ECHA Guidance R8 v2.1, november 2012: "it is usually assumed that a default assessment factor of 10 is sufficient to protect the larger part of the population, including e.g. children and the elderly".
AF for the quality of the whole database:
1
Justification:
The starting study has been performed according to OECD TG 414 and GLP (Klimisch code 1)
AF for remaining uncertainties:
1
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:
0.75 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:
75 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation is not needed: on the assumption that, in general, dermal absorption will not be higher than oral absorption, no default factor (i.e. factor 1) should be introduced when performing oral-to-dermal extrapolation (as mentioned in ECHA Guidance R8 v2.1, november 2012).

AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is a NOAEL (as mentioned in ECHA Guidance R8 v2.1, november 2012).
AF for differences in duration of exposure:
1
Justification:
an AF for exposure duration is not necessary provided that the experimental exposure adequately covered the pregnancy of the species under investigation (as mentioned in ECETOC TR 110, 2010)
AF for interspecies differences (allometric scaling):
4
Justification:
An AS factor of 4 for rat as compared to humans is mentioned in ECHA Guidance R8 v2.1, november 2012.
AF for other interspecies differences:
2.5
Justification:
Default factor as mentioned in ECHA Guidance R8 v2.1, november 2012
AF for intraspecies differences:
10
Justification:
As mentioned in ECHA Guidance R8 v2.1, november 2012: "it is usually assumed that a default assessment factor of 10 is sufficient to protect the larger part of the population, including e.g. children and the elderly".
AF for the quality of the whole database:
1
Justification:
The starting study has been performed according to OECD TG 414 and GLP (Klimisch code 1)
AF for remaining uncertainties:
1
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:
0.75 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:
75 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Route to route extrapolation is not needed as the starting point is oral route. At more the oral absorption between animal and human is supposed identical.

AF for dose response relationship:
1
Justification:
Starting point for the DNEL calculation is a NOAEL (as mentioned in ECHA Guidance R8 v2.1, november 2012).
AF for differences in duration of exposure:
1
Justification:
an AF for exposure duration is not necessary provided that the experimental exposure adequately covered the pregnancy of the species under investigation (as mentioned in ECETOC TR 110, 2010)
AF for interspecies differences (allometric scaling):
4
Justification:
An AS factor of 4 for rat as compared to humans is mentioned in ECHA Guidance R8 v2.1, november 2012.
AF for other interspecies differences:
2.5
Justification:
Default factor as mentioned in ECHA Guidance R8 v2.1, november 2012
AF for intraspecies differences:
10
Justification:
As mentioned in ECHA Guidance R8 v2.1, november 2012: "it is usually assumed that a default assessment factor of 10 is sufficient to protect the larger part of the population, including e.g. children and the elderly".
AF for the quality of the whole database:
1
Justification:
The starting study has been performed according to OECD TG 414 and GLP (Klimisch code 1)
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population