Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.84 mg/m³
Most sensitive endpoint:
effect on fertility
DNEL related information
Overall assessment factor (AF):
225
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.11 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
DNEL related information
Overall assessment factor (AF):
900
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

No DNEL is required for oral exposure of workers since no significant exposure occurs by this route for trained workers (who do not smoke, eat or drink when manipulating chemicals).

No DNELs are required for acute toxic effects, sensitization, irritation and mutagenic effects because the substance does not possess these properties and long-term DNELs are sufficient to cover systemic effects, as a worst-case. Furthermore most of these DNELs can not be calculated with the available qualitative or single-dose data.

No additional assessment factor for route-to-route extrapolation has been used when deriving dermal and inhalation DNELs from data obtained in oral studies. Indeed, the dermal absorption by oral route is considered to be at least as high as absorption by dermal and respiratory routes (2 routes by which absorption is expected to be virtually null). The oral route is therefore an extreme worst-case situation in terms of absorption and the DNELs derived from oral data can be considered as being very conservative.

For the long-term exposure, the dermal DNEL and inhalation DNEL are extrapolated from oral route according to the NOAEL = 1000 mg/kg bw/day obtained from the reproductive toxicity/fertility impairment.

For the inhalation route, NOAELextrapolated = NOAELoral/breathing volume of 0.38 m3/kg bw over 8 hours X 6.7 m3/10 m3 due to physical activity of workers.

For the dermal route, an assessment factor of 900 is applied and is justified as followed:

- interspecies, allometric scaling factor = 4

- interspecies, remaining differences= 2.5

- Exposure duration subacute (28 days) to chronic = 6 (the absence of increase in toxicity with longer treatment duration may be due to unreached toxic level).

- reliability of the dose-response data = 1 (NOAELs availables, no severe effect)

- quality of the complete endpoint-specific database = 3 for the effects on fertility (screening test, no pairing of animals).

For the inhalation route, an assessment factor of 225 is applied and is justified as followed:

- interspecies, allometric scaling factor = 1 (scaling included in corrected dose descriptor)

- interspecies, remaining differences= 2.5

- Exposure duration subacute (28 days) to chronic = 6 (the absence of increase in toxicity with longer treatment duration may be due to unreached toxic level).

- reliability of the dose-response data = 1 (NOAELs availables, no severe effect)

- quality of the complete endpoint-specific database = 3 for the effects on fertility (screening test, no pairing of animals).

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

No assessment and notably no DNEL is required for the general public, as the latter is only exposed to the substances via the use of final cosmetic products. Assessment of human health effects for such exposure is not required by REACH.