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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.6 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):
150
Modified dose descriptor starting point:
NOAEC
Value:
88 mg/m³
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to inhalation NOAEC: 50 mg/kg/day x [1/0.38 x 6.7/10 x 100/100] = 88 mg/m3
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for intraspecies differences:
5
AF for the quality of the whole database:
2
AF for remaining uncertainties:
2.5
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.8 mg/m³
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

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.3 mg/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):
600
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to dermal NOAEL: 50 mg/kg/day x (100/25) = 200 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for intraspecies differences:
5
AF for the quality of the whole database:
2
AF for remaining uncertainties:
2.5
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.9 mg/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

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

Justification for endpoint selection:

-

Acute toxicity (oral): Only one robust study summary available providing lowest dose descriptor relevant for this endpoint.

-

Acute toxicity (dermal): Waived on the basis of Corrosivity.

-

Acute toxicity (inhalation): Waived on the basis of Corrosivity.

-

Irritation / Corrosivity (skin): Robust study summary selected clearly demonstrated Corrosive for this endpoint.

-

Irritation / Corrosivity (eye): Waived on the basis of skin Corrosivity..

-

Sensitisation (skin): Waived on the basis of Corrosivity.

-

Repeated dose toxicity (oral): Only one robust study summary available providing lowest dose descriptor relevant for this endpoint.

-

Repeated dose toxicity (dermal (systemic effects): Waived on the basis of Corrosivity

-

Repeated dose toxicity (dermal (local effects): Waived on the basis of Corrosivity

-

Mutagenicity: Study selected is an in vivo study representative of the substance itself and metabolites (indirect action) and is clearly consistent with the weight of evidence for all in vivo and in vitro studies.

-

Carcinogenicity (oral): No study available.

-

Reproductive toxicity: effects on fertility (oral): Only one robust study summary available providing lowest dose descriptor relevant for this endpoint.

-

Reproductive toxicity: developmental toxicity (oral): Only one robust study summary available providing lowest dose descriptor relevant for this endpoint..

General Population - 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):
300
Modified dose descriptor starting point:
NOAEC
Value:
43 mg/m³
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to inhalation NOAEC: 50 mg/kg/day x (1/1.15) x (100/100) = 43 mg/m³
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for intraspecies differences:
10
AF for the quality of the whole database:
2
AF for remaining uncertainties:
2.5
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.42 mg/m³
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

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.2 mg/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):
1 200
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Convert oral NOAEL to dermal NOAEL: 50 mg/kg/day x (100/25) = 200 mg/kg bw/day
AF for dose response relationship:
2
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
AF for remaining uncertainties:
2.5
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.6 mg/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

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.04 mg/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):
1 200
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for intraspecies differences:
10
AF for the quality of the whole database:
2
AF for remaining uncertainties:
2.5
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.12 mg/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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

Justification for endpoint selection:

-

Acute toxicity (oral): Only one robust study summary available providing lowest dose descriptor relevant for this endpoint.

-

Acute toxicity (dermal): Waived on the basis of Corrosivity.

-

Acute toxicity (inhalation): Waived on the basis of Corrosivity.

-

Irritation / Corrosivity (skin): Robust study summary selected clearly demonstrated Corrosive for this endpoint.

-

Irritation / Corrosivity (eye): Waived on the basis of skin Corrosivity..

-

Sensitisation (skin): Waived on the basis of Corrosivity.

-

Repeated dose toxicity (oral): Only one robust study summary available providing lowest dose descriptor relevant for this endpoint.

-

Repeated dose toxicity (dermal (systemic effects): Waived on the basis of Corrosivity

-

Repeated dose toxicity (dermal (local effects): Waived on the basis of Corrosivity

-

Mutagenicity: Study selected is an in vivo study representative of the substance itself and metabolites (indirect action) and is clearly consistent with the weight of evidence for all in vivo and in vitro studies.

-

Carcinogenicity (oral): No study available.

-

Reproductive toxicity: effects on fertility (oral): Only one robust study summary available providing lowest dose descriptor relevant for this endpoint.

-

Reproductive toxicity: developmental toxicity (oral): Only one robust study summary available providing lowest dose descriptor relevant for this endpoint..