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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
5.14 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:
NOAEL
Value:
62.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
385.69 mg/m³
Explanation for the modification of the dose descriptor starting point:

Calculation was mainly performed via default assumptions given by the DNEL calculator except one additional factor. As indicated by ECHAs guideline R.8, “Default absorption values have been proposed for the different routes of exposure…, but substance-specific data on absorption via the different routes are to be preferred. Such information may for instance be generated based on considerations of the chemical structure“. This approach was followed in the section toxicokinetics. However, this approach is, without explicit testing data on toxicokinetics, tainted with some uncertainties, despite the fact that the deduction of absorption rates was performed scientifically reasonably. So out of precautionary reasons the approach as proposed under R.8.4.2 will be followed as if no route-specific information on the starting route was available, i.e. to include a default factor of 2 (i.e. the absorption percentage for the starting route is half that of the end route). So the present default assessment factor is overridden here out of precautionary reasons, and in consequence the resulting NOAEC (modified dose descriptor starting point) is half as high as it would be when calculated via DNEL calculator.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties. According to the Guidance on Assessment Factors to Derive a DNEL, Technical Report No. 110, Assessment factors for Quality of whole database, i.a. Completeness and consistency of available data, Reliability of alternative data (e.g. read-across) must be regarded, the value should be set as ≥ 1. Due to the high similarity of both substances, i.e. the registered substance and the substance tested in an OECD 421 study which serves as the basis for DNEL derivation, there are no remaining uncertainties left and the value of the AF can be set as 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:
1.46 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:
NOAEL
Value:
62.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
438 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

No long-term study on dermal toxicity is available and required, so only oral toxicity data can be used. The oral route was chosen as it is better suited to assess overall systemic effects. Further, as outlined in detail in subchapter „Toxicokinetics“, dermal absorption is very low compared to the oral route, so testing may have not allowed an assessment of the actual hazard properly and was so omitted due to animal welfare, as testing by the oral route allowed a better assessment. Therefore a route-to-route extrapolation from an oral repeated dose study, as a worst case, is justified.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties. According to the Guidance on Assessment Factors to Derive a DNEL, Technical Report No. 110, Assessment factors for Quality of whole database, i.a. Completeness and consistency of available data, Reliability of alternative data (e.g. read-across) must be regarded, the value should be set as ≥ 1. Due to the high similarity of both substances, i.e. the registered substance and the substance tested in an OECD 421 study which serves as the basis for DNEL derivation, there are no remaining uncertainties left and the value of the AF can be set as 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:
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:
0.91 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):
150
Dose descriptor starting point:
NOAEL
Value:
62.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
135.87 mg/m³
Explanation for the modification of the dose descriptor starting point:

Calculation was mainly performed via default assumptions given by the DNEL calculator except one additional factor. As indicated by ECHAs guideline R.8, “Default absorption values have been proposed for the different routes of exposure…, but substance-specific data on absorption via the different routes are to be preferred. Such information may for instance be generated based on considerations of the chemical structure“. This approach was followed in the section toxicokinetics. However, this approach is, without explicit testing data on toxicokinetics, tainted with some uncertainties, despite the fact that the deduction of absorption rates was performed scientifically reasonably. So out of precautionary reasons the approach as proposed under R.8.4.2 will be followed as if no route-specific information on the starting route was available, i.e. to include a default factor of 2 (i.e. the absorption percentage for the starting route is half that of the end route). So the present default assessment factor is overridden here out of precautionary reasons, and in consequence the resulting NOAEC (modified dose descriptor starting point) is half as high as it would be when calculated via DNEL calculator.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties. According to the Guidance on Assessment Factors to Derive a DNEL, Technical Report No. 110, Assessment factors for Quality of whole database, i.a. Completeness and consistency of available data, Reliability of alternative data (e.g. read-across) must be regarded, the value should be set as ≥ 1. Due to the high similarity of both substances, i.e. the registered substance and the substance tested in an OECD 421 study which serves as the basis for DNEL derivation, there are no remaining uncertainties left and the value of the AF can be set as 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:
0.521 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):
600
Dose descriptor starting point:
NOAEL
Value:
62.5 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
313 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

No long-term study on dermal toxicity is available and required, so only oral toxicity data can be used. The oral route was chosen as it is better suited to assess overall systemic effects. Further, as outlined in detail in subchapter „Toxicokinetics“, dermal absorption is very low compared to the oral route, so testing may have not allowed an assessment of the actual hazard properly and was so omitted due to animal welfare, as testing by the oral route allowed a better assessment. Therefore a route-to-route extrapolation from an oral repeated dose study, as a worst case, is justified.

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties. According to the Guidance on Assessment Factors to Derive a DNEL, Technical Report No. 110, Assessment factors for Quality of whole database, i.a. Completeness and consistency of available data, Reliability of alternative data (e.g. read-across) must be regarded, the value should be set as ≥ 1. Due to the high similarity of both substances, i.e. the registered substance and the substance tested in an OECD 421 study which serves as the basis for DNEL derivation, there are no remaining uncertainties left and the value of the AF can be set as 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:
0.104 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):
600
Dose descriptor starting point:
NOAEL
Value:
62.5 mg/kg bw/day
Value:
62.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
There are no remaining uncertainties. According to the Guidance on Assessment Factors to Derive a DNEL, Technical Report No. 110, Assessment factors for Quality of whole database, i.a. Completeness and consistency of available data, Reliability of alternative data (e.g. read-across) must be regarded, the value should be set as ≥ 1. Due to the high similarity of both substances, i.e. the registered substance and the substance tested in an OECD 421 study which serves as the basis for DNEL derivation, there are no remaining uncertainties left and the value of the AF can be set as 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:
no hazard identified

Additional information - General Population