Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Route of original study:
Dermal
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Route of original study:
Dermal
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

The substance is classified as Category 1A skin sensitizer and thus falls in the high hazard band according to the Guidance on information requirements and chemical safety assessment (Part E). Handling of such substances should be strictly contained and controlled in order to avoid dermal contact and inhalation exposure. Accordingly, no DNELs are derived for long-term and short-term exposure and a qualitative risk characterisation is performed.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEC
Value:
217 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
62.93 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

inhal NOAEC    =    oral NOAEL *   1 / (0.29 m3 / kg / d) 

oral NOAEL      =     inhal NOAEC * 0.29 m3 / kg / d

oral NOAEL      =     217 mg/m3   * 0.29 m3 / kg / d = 62.93 mg/kg/d

dermal NOAEL = oral NOAEL = 62.93 mg/kg/d       

[Reference: Chapter R.8: Characterisation of dose [concentration]-response for human health, pp20-21, ECHA Guidance Document, Version: 2.1, November 2012]

AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
interspecies differences, rat - human
AF for other interspecies differences:
2.5
Justification:
interspecies differences, correction of differences in metabolic rate (general)
AF for intraspecies differences:
10
Justification:
population group: general population
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

The substance is classified as Category 1A skin sensitizer and thus falls in the high hazard band according to the Guidance on information requirements and chemical safety assessment (Part E). However, the only use relevant for consumers is a service life application (Service life in rubber and plastic products (workers, consumers)) for which exposure is generally expected to be low. Accordingly, no DNELs are derived for long-term and short-term exposure and a qualitative risk characterisation is performed.