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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
42.74 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
37.5
Modified dose descriptor starting point:
LOAEC
Value:
1 602.9 mg/m³
Explanation for the modification of the dose descriptor starting point:
LOAECcorr = LOAELoral*(1/0.38 m³/kg bw/day)*(ABSoral-rat/ABSinh-human)*(6.7 m³ (8h)/10 m³ (8h)) = 909.1 mg/kg bw/day*(1/0.38 m³/kg bw/day)*(1/1)*0.67 = 1602.9 mg/m³. Due to metabolic considerations (enzymatic ester hydrolysis), it is assumed that oral absorption rate is 100% of that of inhalation absorption (see Toxicokinetics). ABSoral-rat=oral absorption rate in rats, ABSinh-human=inhalation absorption rate in humans.
AF for dose response relationship:
3
Justification:
DNEL is based on a LOAEL
AF for differences in duration of exposure:
1
Justification:
The factor for exposure duration is not necessary in this case as the observed effects on the male reproductive system are sufficiently taken into account by the subchronic study covering the duration of spermatogenesis.
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
5
Justification:
Default AF for workers
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
60.61 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
LOAEL
Value:
9 091 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
LOAELcorr = LOAELoral*(ABSoral-rat/ABSdermal-human) = (909.1 mg/kg bw/day)*(1/0.1) = 9091 mg/kg bw/day. It is assumed that the dermal absorption rate is 10% of that of the oral absorption according to ECHA CSA Guidance Chapter R.7c Figure R.7.12-5. ABSoral-rat=oral absorption rate in rats, ABSdermal-human=dermal absorption rate in humans.
AF for dose response relationship:
3
Justification:
DNEL is based on a LOAEL
AF for differences in duration of exposure:
1
Justification:
The factor for exposure duration is not necessary in this case as the observed effects on the male reproductive system are sufficiently taken into account by the subchronic study covering the duration of spermatogenesis.
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for rats
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
5
Justification:
Default AF for workers
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

SUBSTANCE-TAILORED EXPOSURE DRIVEN TESTING

In accordance with Annex XI, Section 3 of Regulation (EC) 1907/2006, testing in accordance with Sections 8.7 of Annex VIII and/or section 8.6 and 8.7 of Annex IX was omitted, based on the exposure scenario(s) developed in the Chemical Safety Report, meeting the criteria set out in Annex XI Section 3.2(a).

In particular, in accordance with Annex XI Section 3.2 (a)(ii), the manufacturer or importer shall demonstrate and document that following condition is also fulfilled:

“a DNEL or a PNEC can be derived from results of available test data for the substance concerned taking full account of the increased uncertainty resulting from the omission of the information requirement, and that DNEL or PNEC is relevant and appropriate both to the information requirement to be omitted and for risk assessment purposes”

As required under Regulation (EC) 1907/2006, Annex XI, 3.2 (a)(ii), the appropriate DNELs were derived using the available data, and applied to derive Risk Characterisation Ratios (RCRs).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10.54 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
LOAEC
Value:
790.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
LOAECcorr = LOAELoral*(1/1.15 m³/kg bw/day)*(ABSoral-rat/ABSinh-human) = 909.1 mg/kg bw/day*(1/1.15 m³/kg bw/day)*(1/1) = 790.5 mg/m³. Due to metabolic considerations (enzymatic ester hydrolysis), it is assumed that oral absorption rate is 100% of that of inhalation absorption (see Toxicokinetics). ABSoral-rat=oral absorption rate in rats, ABSinh-human=inhalation absorption rate in humans.
AF for dose response relationship:
3
Justification:
DNEL is based on a LOAEL
AF for differences in duration of exposure:
1
Justification:
The factor for exposure duration is not necessary in this case as the observed effects on the male reproductive system are sufficiently taken into account by the subchronic study covering the duration of spermatogenesis
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
10
Justification:
Default AF for general population
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
30.3 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
LOAEL
Value:
9 091 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
LOAELcorr = LOAELoral*(ABSoral-rat/ABSdermal-human) = (909.1 mg/kg bw/day)*(1/0.1) = 9091 mg/kg bw/day. It is assumed that the dermal absorption rate is 10% of that of the oral absorption according to ECHA CSA Guidance Chapter R.7c Figure R.7.12-5. ABSoral-rat=oral absorption rate in rats, ABSdermal-human=dermal absorption rate in humans.
AF for dose response relationship:
3
Justification:
DNEL is based on a LOAEL
AF for differences in duration of exposure:
1
Justification:
The factor for exposure duration is not necessary in this case as the observed effects on the male reproductive system are sufficiently taken into account by the subchronic study covering the duration of spermatogenesis.
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for rats
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
10
Justification:
Default AF for general population
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
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:
3.03 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
LOAEL
Value:
909.1 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No route-to-route extrapolation is required.
AF for dose response relationship:
3
Justification:
DNEL is based on a LOAEL
AF for differences in duration of exposure:
1
Justification:
The factor for exposure duration is not necessary in this case as the observed effects on the male reproductive system are sufficiently taken into account by the subchronic study covering the duration of spermatogenesis.
AF for interspecies differences (allometric scaling):
4
Justification:
Default AF for rats
AF for other interspecies differences:
2.5
Justification:
Default AF
AF for intraspecies differences:
10
Justification:
Default AF for general polulation
AF for the quality of the whole database:
1
Justification:
DNEL is based on a high-quality study
AF for remaining uncertainties:
1
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

SUBSTANCE-TAILORED EXPOSURE DRIVEN TESTING

In accordance with Annex XI, Section 3 of Regulation (EC) 1907/2006, testing in accordance with Sections 8.7 of Annex VIII and/or section 8.6 and 8.7 of Annex IX was omitted, based on the exposure scenario(s) developed in the Chemical Safety Report, meeting the criteria set out in Annex XI Section 3.2(a).

In particular, in accordance with Annex XI Section 3.2 (a)(ii), the manufacturer or importer shall demonstrate and document that following condition is also fulfilled:

“a DNEL or a PNEC can be derived from results of available test data for the substance concerned taking full account of the increased uncertainty resulting from the omission of the information requirement, and that DNEL or PNEC is relevant and appropriate both to the information requirement to be omitted and for risk assessment purposes”

As required under Regulation (EC) 1907/2006, Annex XI, 3.2 (a)(ii), the appropriate DNELs were derived using the available data, and applied to derive Risk Characterisation Ratios (RCRs).