Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.42 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
DNEL value:
17 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
21 mg/m³
Explanation for the modification of the dose descriptor starting point:

- standard respiratory volume (rat) = 0.38 m³/kg/8h

- standard respiratory volume (human) = 6.7 m³/8h

- worker respiratory volume = 10 m³/8h

- absorption (oral, rat) = 50 % (default)

- absorption (inhalative, human) = 100 % (default)

--> modified dose descriptor (corrected inhalatory NOAEC) = oral NOAEL/0.38 x (50/100) x (6.7/10) x (7 exposure days/week; rat/5 exposure days/week; worker)

AF for dose response relationship:
1
Justification:
ECHA REACH Guidance (starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
4
Justification:
According to the ECHA REACH Guidance an assessment factor (AF) of 6 should be used as default value for a subacute study and a factor of 2 for a sub-chronic study. The NOAEL used for hazard assessment was determined from a repeated dose study (combined with reproduction/ developmental toxicity screening test) where the animals were treated continuously for a period of 66 days, which is twice as long as in a subacute study. Thus, an assessment factor of 4 (2x AF of a subacute study) is used to extrapolate from this study duration to a chronic study.
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling has to be applied in case of oral to inhalation route to route extrapolation.
AF for other interspecies differences:
2.5
Justification:
ECHA REACH Guidance
AF for intraspecies differences:
5
Justification:
ECHA REACH Guidance
AF for the quality of the whole database:
1
Justification:
ECHA REACH Guidance (good/standard quality of the database)
AF for remaining uncertainties:
1
Justification:
ECHA REACH Guidance
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)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Justification:
The quality of the whole data base is considered to be sufficient and uncritical.
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information
Explanation for the modification of the dose descriptor starting point:

There are no data on acute dermal toxicity available, because due to the corrosivity of the test substance a study does not need to be conducted (according to REACH Regulation No 1907/2006).

On the basis of the classification for acute toxicity (oral) cat. 3 and for corrosivity cat. 1C, a medium hazard is assessed in accordance to ECHA’s Guidance, part E, Table E.3-1.

The use of stringent risk management measures as outlined in the ECHA guidance document is required in order to prevent any contact with the test substance. This will also protect the worker from any systemic dermal effects.

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Explanation for the modification of the dose descriptor starting point:
No consumer uses were identified. The general population does not get in contact with the substance. Therefore, in accordance with the REACH legislation (regulation (EC) No 1907/2006, Annex I, 1.4.1), no DNEL has to be derived for the general population.
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population