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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
2.35 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):
37.5
Dose descriptor starting point:
LOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
88.105 mg/m³
Explanation for the modification of the dose descriptor starting point:

The NOAEL is taken from a 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test according to OECD TG 422

in rats. It is assumed that oral absorption of the substance is half that of inhalation absorption.

Inhalatory N(L)OAEC = oral N(L)OAEL*(1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh.)

= 100 * 2.63 * 0.67 * 0.5

= 88.105 mg/m3

AF for dose response relationship:
3
Justification:
As the dose descriptor is the LOAEL.
AF for differences in duration of exposure:
1
Justification:
To account for using PoD taken from a developmental study to calculate a chronic DNEL. Timescales are not applicable since developmental toxicity does not get worse with longer exposure but is relevant to a critical time window and the experimental exposure adequately covers the pregnancy of the species under investigation.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is usually not applied in the derivation of the inhalation DNEL.
AF for other interspecies differences:
2.5
Justification:
Default factor.
AF for intraspecies differences:
5
Justification:
To account for intraspecies differences in an occupational setting.
AF for the quality of the whole database:
1
Justification:
The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.35 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):
37.5
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:

As an acute toxicity hazard leading to classification and labelling of the substance has not been identified, the long-term DNEL is considered sufficient to ensure that effects from acute exposure to the substance do not occur.

Local effects

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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.67 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor starting point:
LOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The LOAEL is taken from a 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test according to OECD TG 422 in rats, resulting in a LOAEL of 100 mg/kg bw/day.

 

Dermal N(L)OAEL=oral (N(L)OAEL*( ABSoral/ABSdermal)

                = 100 x (1/1)

 

AF for dose response relationship:
3
Justification:
As the dose descriptor is the LOAEL.
AF for differences in duration of exposure:
1
Justification:
To account for using PoD taken from a developmental study to calculate a chronic DNEL. Timescales are not applicable since developmental toxicity does not get worse with longer exposure but is relevant to a critical time window and the experimental exposure adequately covers the pregnancy of the species under investigation.
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling to account for differences in allometry in using the rat as a test model.
AF for other interspecies differences:
2.5
Justification:
Default factor.
AF for intraspecies differences:
5
Justification:
To account for intraspecies differences in an occupational setting.
AF for the quality of the whole database:
1
Justification:
The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.67 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):
150
DNEL extrapolated from long term DNEL
Explanation for the modification of the dose descriptor starting point:

As an acute toxicity hazard leading to classification and labelling of the substance has been identified, the long-term DNEL is considered sufficient to ensure that effects from acute exposure to the substance do not occur.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.183 mg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
262.5
Dose descriptor:
LOAEC
Value:
480 000 mg/m³
AF for dose response relationship:
3
Justification:
As the dose descriptor is the LOAEL.
AF for differences in duration of exposure:
1
Justification:
To account for specific exposure condition considerations - this concerns situations when the experimental set up (animal or human) differs from actual human exposure conditions, by e.g. different parts of the body being exposed, differences in skin integrity caused by specific human activities, occlusion of the exposed skin and differences in exposure frequency between the animal/human study and actual human exposure situation.
AF for interspecies differences (allometric scaling):
7
Justification:
Allometric scaling to account for differences in allometry in using the mouse as a test model.
AF for other interspecies differences:
2.5
Justification:
Default factor.
AF for intraspecies differences:
5
Justification:
To account for intraspecies differences.
AF for the quality of the whole database:
1
Justification:
The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.183 mg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
262.5
Dose descriptor starting point:
LOAEC
Value:
480 000 mg/m³

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:
0.58 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):
75
Dose descriptor starting point:
LOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
43.45 mg/m³
Explanation for the modification of the dose descriptor starting point:

In the absence of a repeated dose toxicity study conducted via the inhalation route of exposure the use of a PoD using the oral route of exposure has been employed.

The NOAEL is taken from a 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test according to OECD TG 422 in rats. It is assumed that oral absorption of the substance is half that of inhalation absorption.

 

Inhalatory N(L)OAEC = oral N(L)OAEL*(1/1.15 m3/kg bw/d)*(ABSoral/ABSinh.)

= 100 * 0.869 * 0.5

= 43.45 mg/m3

AF for dose response relationship:
3
Justification:
As the dose descriptor is the LOAEL.
AF for differences in duration of exposure:
1
Justification:
To account for using PoD taken from a developmental study to calculate a chronic DNEL. Timescales are not applicable since developmental toxicity does not get worse with longer exposure but is relevant to a critical time window and the experimental exposure adequately covers the pregnancy of the species under investigation.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling is usually not applied in the derivation of the inhalation DNEL.
AF for other interspecies differences:
2.5
Justification:
Default factor.
AF for intraspecies differences:
10
Justification:
To account for intraspecies differences.
AF for the quality of the whole database:
1
Justification:
The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.58 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):
75
DNEL extrapolated from long term DNEL

Local effects

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

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.33 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):
300
Dose descriptor starting point:
LOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL is taken from a repeat dose toxicity study via the oral route of exposure.

 

Dermal N(L)OAEL=oral (N(L)OAEL*( ABSoral/ABSdermal)

= 100 * (1/1)

= 100 mg/kg bw/day

AF for dose response relationship:
3
Justification:
As the dose descriptor is the LOAEL.
AF for differences in duration of exposure:
1
Justification:
To account for using PoD taken from a developmental study to calculate a chronic DNEL. Timescales are not applicable since developmental toxicity does not get worse with longer exposure but is relevant to a critical time window and the experimental exposure adequately covers the pregnancy of the species under investigation.
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling to account for differences in allometry in using the rat as a test model.
AF for other interspecies differences:
2.5
Justification:
Default factor.
AF for intraspecies differences:
10
Justification:
To account for intraspecies differences.
AF for the quality of the whole database:
1
Justification:
The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.33 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):
300
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.14 mg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
525
Dose descriptor:
LOAEC
Value:
4 800 µg/m³
AF for dose response relationship:
3
Justification:
As the dose descriptor is the LOAEL, the assessment factor is 3.
AF for differences in duration of exposure:
1
Justification:
To account for specific exposure condition considerations - this concerns situations when the experimental set up (animal or human) differs from actual human exposure conditions, by e.g. different parts of the body being exposed, differences in skin integrity caused by specific human activities, occlusion of the exposed skin and differences in exposure frequency between the animal/human study and actual human exposure situation.
AF for interspecies differences (allometric scaling):
7
Justification:
Allometric scaling to account for differences in allometry in using the mouse as a test model.
AF for other interspecies differences:
2.5
Justification:
Default factor.
AF for intraspecies differences:
10
Justification:
To account for intraspecies differences in an occupational setting.
AF for the quality of the whole database:
1
Justification:
The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
AF for remaining uncertainties:
1
Justification:
The matrix is very similar to the matrix used to determine the EC3 and is not expected to increase the potential for induction of sensitisation.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.14 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
525
Dose descriptor starting point:
LOAEC
Value:
4 800 µg/m³

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.33 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):
300
Dose descriptor starting point:
LOAEL
Value:
100 mg/kg bw/day
AF for dose response relationship:
3
Justification:
As the dose descriptor is the LOAEL.
AF for differences in duration of exposure:
1
Justification:
To account for using PoD taken from a developmental study to calculate a chronic DNEL. Timescales are not applicable since developmental toxicity does not get worse with longer exposure but is relevant to a critical time window and the experimental exposure adequately covers the pregnancy of the species under investigation.
AF for interspecies differences (allometric scaling):
4
Justification:
Allometric scaling to account for differences in allometry in using the rat as a test model.
AF for other interspecies differences:
2.5
Justification:
Default factor.
AF for intraspecies differences:
10
Justification:
To account for intraspecies differences.
AF for the quality of the whole database:
1
Justification:
The database has a good quality, taking into account completeness, consistency and the standard information requirements, therefore the default factor of 1 applies.
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties identified therefore not applicable.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.33 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):
300
DNEL extrapolated from long term DNEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population