Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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