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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.027 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor starting point:
NOAEC
Value:
3.97 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
1.99 mg/m³
Explanation for the modification of the dose descriptor starting point:

The calculation of the DNEL is based on an inhalation NOAEC observed in a repeated dose inhalation toxicity study (similar to OECD 412; 2000).
Conversion of an inhalatory rat NOAEC into a corrected inhalatory NOAEC in case of differences between experimental and human exposure condition has to be performed.
Corrected starting point for the inhalative route for workers:
= NOAEC(inhalation) * exposure condition rat / exposure condition human
= 3.97 mg/m³ * (6h/day / 8h/day) * (6.7 m³ (8h) /10 m³ (8h))
= 3.97 mg/m³ * 0.75 * 0.67 = 1.99 mg/m³


Thus, the corrected starting point for workers was 1.99 mg/m³ for inhalation.

Justification:
The dose descriptor starting point is based on a NOAEL.
Justification:
The DNEL is based on a subacute study.
Justification:
allometric scaling is not necessary for inhalation route
Justification:
Default value according to ECHA REACH Guidance
Justification:
Default value for workers according to ECHA REACH Guidance.
Justification:
Whole database is comprehensive and good quality
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.015 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor:
NOAEC
Value:
1.12 mg/m³
Justification:
The dose descriptor starting point is based on a NOAEL.
Justification:
The DNEL is based on a subacute study.
Justification:
Not required for local effects.
Justification:
Default value according to ECHA REACH Guidance.
Justification:
Default value for workers according to ECHA REACH Guidance.
Justification:
Whole database is comprehensive and good quality
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Justification:
The dose descriptor starting point is based on a NOAEL.
Justification:
The DNEL is based on a subacute study.
Justification:
The experimental animal was a rabbit.
Justification:
Default value according to ECHA REACH Guidance.
Justification:
Default value for workers according to ECHA REACH Guidance.
Justification:
Whole database is comprehensive and good quality
Justification:
No remaining 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:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity

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:
6.6 µg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor starting point:
NOAEC
Value:
3.97 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
0.99 mg/m³
Explanation for the modification of the dose descriptor starting point:

The calculation of the DNEL is based on an inhalation NOAEC observed in a repeated dose inhalation toxicity study (similar to OECD 412; 2000).
Conversion of an inhalatory rat NOAEC into a corrected inhalatory NOAEC in case of differences between experimental and human exposure condition has to be performed.
Corrected starting point for the inhalative route for the general population:
= NOAEC (inhalation) * exposure condition rat / exposure condition human
= 3.97 mg/m³ * (6h/day / 24h/day) 
= 3.97 mg/m³ * 0.25 = 0.99 mg/m³


Thus, the corrected starting point for workers was 0.99 mg/m³ for inhalation.

Justification:
The dose descriptor starting point is based on a NOAEL.
Justification:
The DNEL is based on a subacute study.
Justification:
AF for allometric scaling not required for inhalation route
Justification:
Default value according to ECHA REACH Guidance
Justification:
Default value for general population according to ECHA REACH Guidance.
Justification:
Whole database is comprehensive and of good quality
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.5 µg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor:
NOAEC
Value:
1.12 mg/m³
Justification:
The dose descriptor starting point is based on a NOAEL.
Justification:
The DNEL is based on a subacute study.
Justification:
No AF required for local effects.
Justification:
Default value according to ECHA REACH Guidance.
Justification:
Default value for general population according to ECHA REACH Guidance.
Justification:
Whole database is comprehensive and good quality.
Justification:
No remaining uncertainties.
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:
0.69 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Justification:
The dose descriptor starting point is based on a NOAEL.
Justification:
The DNEL is based on a subacute study.
Justification:
The experimental animal was a rabbit.
Justification:
Default value according to ECHA REACH Guidance.
Justification:
Default value for general population according to ECHA REACH Guidance.
Justification:
Whole database is comprehensive and good quality.
Justification:
No remaining 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:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
0.038 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:
NOAEL
Value:
7.6 mg/kg bw/day
Justification:
The dose descriptor starting point is based on a NOAEL.
Justification:
The DNEL is based on a subchronic study.
Justification:
The experimental animal was a rat.
Justification:
Default value according to ECHA REACH Guidance.
Justification:
Default value for general population according to ECHA REACH Guidance.
Justification:
Whole database is comprehensive and of good quality.
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population