Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
20 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
Value:
3 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
Not applicable.
AF for dose response relationship:
1
Justification:
A NOAEC has been chosen as a start of departure
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling used in derivation of inhalation DNEL based on inhalation study
AF for other interspecies differences:
2.5
Justification:
Default factor used for interspecies remaining differences
AF for intraspecies differences:
5
Justification:
Default factor used for worker
AF for the quality of the whole database:
1
Justification:
Appropriate completeness and adequacy of the database
AF for remaining uncertainties:
1
Justification:
Not applicable
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:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
no hazard identified

Additional information - workers

Anisole is classified STOT SE cat.3 H 3336: May cause drowsiness and dizziness. Based only on this classification no risk assessment is required (Guidance on information requirements and chemical safety assessment Part B: Haeard assessment). However based on the 29 day inhalation study performed in rats reversible non adverse effects with no histopathological findings were observed at the higher concentration. Therefore the higher concentration tested in this study was chosen as a No-Adverse-Effect-Concentration (NOAEC) and a systemic inhalation long term DNEL was set for workers. The narcotic effects appeared after inhalation exposure of Anisole will be protected by a quantitative risk assessment using this DNEL (Guidance on information requirements and chemical safety assessment Part E: Risk characterisation).

The EU H066 class (repeated exposure may cause skin dryness or cracking) is not a classification; therefore no risk assessment is mandatory (Guidance on information requirements and chemical safety assessment Part E: Risk characterisation).

However gloves with basic training are sufficient to protect from this type of effects.

 

For details on DNEL derivation, please see above.

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:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Anisole is used as solvent and intermediate and therefore this substance is never present in consumers’ products. Thus consumers are not exposed to Anisole. Furthermore, since the substance is biodegradable and not bioaccumulable exposure to humans via environment should be very low.

Taking into account these elements, since general population is not exposed to Anisole, no risk assessment in order to protect this kind of population is needed.