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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
39.2 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
90
Modified dose descriptor starting point:
NOAEC
Value:
3 526 mg/m³
Explanation for the modification of the dose descriptor starting point:
According to Guidance on information requirements and chemical safety assessment Chapter R.8. Figure R.8-3.
Justification:
Not applicable
AF for differences in duration of exposure:
10
Justification:
Expert judgement
Justification:
Chapter R.8. Table 8-4, page 32.
Justification:
Chapter R.8. Table 8-4, page 32.
AF for intraspecies differences:
3
Justification:
Chapter R.8. Table R,8-19, page 76-77.
AF for the quality of the whole database:
3
Justification:
Expert Judgement for lack of repeate-dose and developmental/repro. data.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
39.2 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
90
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
39.2 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
90
Dose descriptor:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
39.2 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
90
Dose descriptor starting point:
NOAEC

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.6 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
360
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
ECHA guidance Chapter R.8. Table R. 8-4. page 32.
AF for differences in duration of exposure:
10
Justification:
Expert Judgement
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA guidance Chapter R.8. Table 8-3, page 30.
Justification:
ECHA guidance Chapter R.8. Table R. 8-4, page 32.
AF for intraspecies differences:
3
Justification:
ECHA guidance Chapter R.8. Table 8-19, pages 76-77.
AF for the quality of the whole database:
3
Justification:
Expert Judgement due to lack of repeate-dose and developmental/repro. data.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.6 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
360
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.9 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
63
Dose descriptor:
other: LOAEL
Justification:
EC3 calculated as per REACH guidance Chapter R.8. Appendix R. 8-10, Skin Sensitization, page 128.
Justification:
Not applicable
AF for interspecies differences (allometric scaling):
7
Justification:
As per REACh guidance Chapter R.8. Table R. 8-3, page 30
AF for intraspecies differences:
3
Justification:
As per REACH guidance Chapter R.8. Table R. 8-19, pages 76-77.
Justification:
Mouse LLNA was conducted as per OECD guideline with GLP compliance, no AF required.
AF for remaining uncertainties:
3
Justification:
LOAEL to NOAEL as per REACH guidance Chapter R.8, Appendix R. 8-10, page 128 and Section R.8.4.3.1. page 36.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.9 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
63
Dose descriptor starting point:
other: LOAEL

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

DNELs for long-term inhalation and dermal exposures are judged to be protective for acute short-term effects. The DNEL derived for dermal local long-term sensitisation effects is judged to be protective for dermal local acute/short-term sensitisation effects.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.5 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Value:
3 526 mg/m³
Explanation for the modification of the dose descriptor starting point:
As per ECHA guidance Chapter R.8. Figure R.8-3, page 27.
AF for differences in duration of exposure:
10
Justification:
Expert Judgement
Justification:
Not required as per ECHA guidance Chapter R.8, Table R.8-4, page 32.
AF for intraspecies differences:
5
Justification:
As per ECHA guidance Chapter R.8, Table R.8-19, pages 76-77.
AF for the quality of the whole database:
3
Justification:
Expert judgement due to lack of repeated-dose and developmentl/repro. data.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.5 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor:
NOAEC
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:
3.3 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable
AF for differences in duration of exposure:
10
Justification:
Expert Judgement
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA guidance Chapter R.8. Table R.8-3. page 30.
AF for intraspecies differences:
5
Justification:
ECHA guidance Chapter R.8. Table R.8-19, pages 76-77.
AF for the quality of the whole database:
3
Justification:
Expert Judgement due to lack of repeated-dose and developomental/repro. data.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.3 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.76 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
105
Dose descriptor:
other: EC3
AF for dose response relationship:
3
Justification:
LOAEL to NOAEL as per ECHA guidance Chapter R.8. Appendix R.8-10, Skin Sensitisation and Section R.8.4.3.1. page 36.
Justification:
Not applicable
AF for interspecies differences (allometric scaling):
7
Justification:
ECHA guidance Chapter R.8 Table 8-3, page 30.
AF for intraspecies differences:
5
Justification:
ECHA guidance Chapter R.8. Table R.8-19, pages 76-77
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.76 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
105
Dose descriptor starting point:
other: LOAEL

General Population - Hazard via oral route

Systemic 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 for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

An inhalation DNEL for both short and long term expsoure of 23.5 mg/m3 is established. The systemic effects dermal DNEL is 3.3 mg/kg/day. A dermal local effects DNEL of 4.76 ug/cm2 is established to protect the General Population from skin sensitization.