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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
DNEL (Derived No Effect Level)
Value:
8.82 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
Modified dose descriptor starting point:
NOAEC
Value:
440.8 mg/m³
Explanation for the modification of the dose descriptor starting point:

The NOAEL for the systemic toxicity was 1000 mg/kg bw per day in the key study (OECD 422). Step 1) Relevant dose-descriptor: NOAEL, rat, systemic toxicity = 1000 mg/kg bw per day Step 2) Modification of starting point - Conversion into inhalation NOAEC (in mg/m³) by using an 8-hour respiratory volume for the rat: 0.38 m³/kg bw - Correction for activity driven differences of respiratory volumes in workers compared to workers in rest: 6.7 m³/10 m³ - Correction for inhalation to oral absorption: no factor is added. Justification: the test substance is expected to have a low volatility - No difference in oral and inhalation absorption is expected between rats and human. NOAEC corrected = 1000*1/0.38*6.7/10 = 1763.2 mg/m³



As the key study was performed with the registered substance at about 25%, the NOAEL value was corrected.=> NOAEC corrected for registered substance = 440.8 mg/m3

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
4
Justification:
subchronic (about 54 days) to chronic = 4
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
1
Justification:
Klimich 1, GLP study
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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The NOAEL for the systemic toxicity was 1000 mg/kg bw per day in the key study (OECD 422). Step 1) Relevant dose-descriptor: NOAEL, rat = 1000 mg/kg bw per day Step 2) Modification of starting point Correcting for dermal to oral absorption: factor of 1 is used. As no dermal penetration study is available, 100% absorption will be considered as a worst case. No difference in oral and dermal absorption is expected between rats and human. Corrected dermal NOAEL: 1000 mg/kg-day x 100%/100% = 1000 mg/kg-day.



As the key study was performed with the registered substance diluted at about 25%, the NOAEL value was corrected=> NOAEL corrected for dermal route for the registered substance = 250 mg/kg bw/d

AF for dose response relationship:
1
Justification:
NOAEL available
AF for differences in duration of exposure:
4
Justification:
subchronic (about 54 days) to chronic = 4
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
1
Justification:
GLP study, K1
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

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:
no hazard identified
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