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Administrative data

Workers - 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:
other toxicological threshold
Value:
10 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: An approach for deliniation of generic cut-off values for local respiratory tract irritation
Dose descriptor:
other: 129 irritating or corrosive industrial chemical substances with an established TLV
AF for dose response relationship:
1
AF for differences in duration of exposure:
1
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
1
AF for intraspecies differences:
1
AF for the quality of the whole database:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - 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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

Although a DNEL, systemic is not required because the oral subacute toxicity study gives no evidence for systemic toxicity (NOAEL = 1000 mg/kg = limit dose) it was calculated to evaluate whether it might be suitable for protection against potential local irritation effects.

Worker

Inhalation - Systemic effects - Long-term

DNEL derivation method: ECHA REACH Guidance

Justification for route-to-route extrapolation:

For the given human exposure route there is not a dose descriptor for the same route in experimental animals. Oral data from the rat are used to decide on a corresponding air concentration for humans. Therefore a route-to-route extrapolation for systemic effects is necessary to derive the correct starting point. In the case of oral-to-inhalation the inclusion of a default factor of 2 is recommended according to ECHA Guidance (November 2012) R.8.4.2. According to Figure Figure R. 8-3 in the Guidance Document R.8 (ECHA, 2012) additional correction is needed for scaling issues:                                                                              Corrected inhalatory NOAEC = oral NOAEL * 0.5 * 1/0.38 kg/m³ * 6.7 m³/10 m³ = 881 mg/m³. The NOAEC was further adjusted for an exposure duration of 5 days a week instead of 7 days in the experimental situation ( 881 * 7/5 = 1233 mg/m³)

Dose descriptor starting point:NOAEC 1233 mg/m³

AF for dose response relationship:1 (The starting point for the DNEL calculation is a NOAEL according to ECHA Guidance (November 2012), R.8.4.3.1 the default assessment factor, as a standard procedure, is 1.

AF for difference in duration of exposure:6 (Difference in the experimental exposure duration (= subacute) and the duration of exposure for the population and scenario under consideration (= chronic) according to ECHA Guidance (November 2012) Chapter R. 8. Table R.8-5.)

AF for interspecies differences (allometric scaling): 1 Already covered by correction of the starting point (see justification for route to route extrapolation)

AF for other interspecies differences:2.5 (A factor 2.5 for remaining differences is suggested by the Guidance Document R.8 (ECHA, 2012))

AF for intraspecies differences:5 (According to ECHA Guidance (November 2012) Chapter R.8.4.3.1 the default AF to be applied for intraspecies differences in workers is 5.)

AF for quality of the whole database:1 According to ECHA Guidance (November 2012) R.8.4.3.1 the default AF to be applied for good/standard quality of the database, taking into account completeness, consistency and the standard information requirements, is 1.

Overall Assessment Factor:75

DNEL (Derived No Effect Level): 17 mg/m³ ( repeated dose toxicity (Oral))

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:
medium hazard (no threshold derived)
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:
medium hazard (no threshold derived)

Additional information - General Population