Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.67 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
AF for interspecies differences (allometric scaling):
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for remaining uncertainties:
6
Justification:
Study duration extrapolation (from subacute to chronic studies)
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:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
AF for interspecies differences (allometric scaling):
4
Justification:
Default for rats
AF for other interspecies differences:
2.5
Justification:
Default for remaining interspecies variabilities
AF for intraspecies differences:
5
Justification:
Default factor for workers
AF for remaining uncertainties:
6
Justification:
Study duration extrapolation (from subacute to chronic studies)
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:
hazard unknown (no further information necessary)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown (no further information necessary)

Additional information - workers

The substance is not classified for human health.

The substance showed some evidence of mild dermal irritation in two skin irritation studies. However, a DNEL for acute/short-term local effects was not able to be derived from these studies.

The only DNELs derived are for long-term systemic effects for dermal and inhalation routes, which have been derived in order to assess risks from worker exposure.

The result used to derive these DNELs was the NOAEL result of 1000 mg/kg bw/day for systemic toxicity, obtained from the OECD 422 Oral (Gavage) Combined Repeat Dose Toxicity Study With Reproduction / Developmental Toxicity Screening Test in the Rat.

The corrected dose descriptor of 875.0 mg/m3for inhalation was calculated in accordance with the ECHA Guidance on information requirements and chemical safety assessment,Chapter R.8: Characterisation of dose [concentration]-response for human health.

The conversion of an oral rate NOAEL into a corrected inhalatory NOAEC to assess human inhalatory exposure was performed using the modification of starting point equation as given in Figure R. 8-3 (of the above guidance) for workers (in the case of 8 hour exposure/day). This corrected dose descriptor was based on worst case assumptions for absorption (i.e. the absorption percentage for the oral route is half that for the inhalation route). The inclusion of this factor means that 50% absorption was assumed for oral absorption and 100% absorption assumed for inhalation. This leads to the most conservative corrected dose descriptor.

Default parameters for rats and human (for 8 hour exposure) were used for the allometric scaling principle.

 

General Population - Hazard via inhalation 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

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:
no hazard identified
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:
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:
no hazard identified

Additional information - General Population

DNELs have not been derived for the general public as there will be no exposure to the general public/consumers.

The substance will only be used by industry and not by the public. Due to minimal release of the substance from industrial use, exposure to the general public is not anticipated.