Registration Dossier

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.