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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The starting point of 4.1 mg/kg bw/d from a mouse oral study is modified as follows:


Taking into account standard respiratory volume for the mouse (0.672 m3/kg bw);


Taking into account the extent of oral absorption (65%, measured) and inhalation absorption (100%, assumed);


Taking into account the standard human respiratory volume (6.7 m3/8 hours) and the worker respiratory volume (10 m3/8 hours);


The modified starting point (human inhalation LOAEC) is therefore:


4.1 * (1/0.672) * (65/100) * (6.7/10) = 2.66 mg/m3

Justification:
An AF of 3 is used as the starting point is a LOAEL
Justification:
An AF is not required as the starting point is derived from a study of chronic duration
Justification:
An AF is not required as allometric factors are already accounted for in derivation of the corrected starting point
Justification:
A default AF of 2.5 is used, according to REACH Guidance
Justification:
A default AF of 5 is used, according to REACH Guidance
Justification:
An AF is not required due to the availability of a high quality database
Justification:
An AF is not required due to the availability of a comprehensive database; there are 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:
0.34 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor starting point:
LOAEL
Value:
4.1 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
89 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting point of 4.1 mg/kg bw/d from an oral study in the mouse (LOAEL) is modified, taking into account the extent of oral absorption in the mouse (65%) and the extent of dermal absorption in humans (3%, worst case).


The modified starting point (human dermal LOAEL) is therefore 89 mg/kg bw/d.

Justification:
An AF of 3 is used as the starting point is a LOAEL.
Justification:
An AF is not required as the starting point is from a study of chronic duration
Justification:
An AF of 7 is used as the starting point is from a study in the mouse
Justification:
A default AF of 2.5 is used, according to REACH Guidance
Justification:
A default AF of 5 is used, according to REACH Guidance
Justification:
An AF is not required due to the availability of a high quality database
Justification:
An AF is not required due to the availability of a comprehensive database, with no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium 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:
0.018 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor starting point:
LOAEL
Value:
4.1 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
1.33 mg/m³
Explanation for the modification of the dose descriptor starting point:

The starting point (LOAEL) of 4.1 mg/kg bw/d from a mouse oral study is modified as follows:


Taking into account standard respiratory volume for the mouse (2.01 m3/kg bw);


Taking into account the extent of oral absorption (65%, measured) and inhalation absorption (100%, assumed);


The modified starting point (human inhalation LOAEC) is therefore:


4.1 * (1/2.01) * (65/100) = 1.33 mg/m3

Justification:
An AF of 3 is used as the starting point is a LOAEL
Justification:
An AF is not required as the starting point is derived from a study of chronic duration
Justification:
An AF is not required as allometric factors are accounted for in modification of the starting point
Justification:
A default factor of 2.5 is used, according to REACH Guidance
Justification:
A default factor of 10 is used, according to REACH Guidance
Justification:
An AF is not required based on the availability of a high quality database
Justification:
An AF is not required based on the availability of a comprehensive database with 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:
0.17 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor starting point:
LOAEL
Value:
4.1 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
89 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The starting point of 4.1 mg/kg bw/d from an oral study in the mouse (LOAEL) is modified, taking into account the extent of oral absorption in the mouse (65%) and the extent of dermal absorption in humans (3%, worst case).


The modified starting point (human dermal LOAEL) is therefore 89 mg/kg bw/d.

Justification:
An AF of 3 is used as the starting point is a LOAEL
Justification:
An AF is not required as the starting point is a LOAEL
Justification:
An AF of 7 is used as the starting point is a mouse study
Justification:
A default AF of 2.5 is used, according to REACH guidance
Justification:
A default AF of 10 is used, according to REACH guidance
Justification:
An AF is not required due to the availability of a high quality database
Justification:
An AF is not required due to the availability of a comprehensive database with no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

General Population - Hazard via oral route

Systemic effects

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

Modification of the starting point is not required; the starting point is derived from an oral study in the mouse, the extent of oral absorption in the mouse and in humans is assumed to be similar (65%).

Justification:
An AF of 3 is used as the starting point is a LOAEL
Justification:
An AF is not required as the starting point is from a study of chronic duration
Justification:
An AF of 7 is used as the starting point is derived from a mouse study
Justification:
A default AF of 2.5 is used, in accordance with REACH Guidance
Justification:
A default AF of 10 is used, in accordance with REACH Guidance
Justification:
An AF is not required due to the availability of a high quality database
Justification:
An AF is not required due to the availability of a comprehensive database with no remaining uncertainties
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