Registration Dossier

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:
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:
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:
no hazard identified

Additional information - workers

As the substance is not considered to be toxic or harmful after oral and dermal exposure, acute (systemic) DNELs do not need to be derived. As the substance is not considered to be irritating to skin and eyes, acute (local) DNELs do not need to be derived.

Only signs of unspecific toxicity (effects on body weight gain) were observed at a dose higher than the limit dose in a 90-d study in rats. The test substance does not pose any specific risk following repeated oral exposure.

The results of the OECD 421 study (NOEL = 1000 mg/kg bw nominal) did not indicate adverse effects on reproductive organs or tissues and no concern exists in relation with reproductive toxicity. In addition, an OECD 415 (1-gen study) conducted with a structural analogue also did not indicate any adverse effects.

As the substance is not considered to be hazardous with respect to long-term effects, long term (systemic) DNELs do not need to be derived. As local effects were not observed in the repeated dose toxicity study, long term (local) DNELs do not need to be derived.

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:
no hazard identified

Additional information - General Population

The substance is not readily available to consumers, as there is very little potential for the substance to be released from the polymers once it has been consumed in the polymer manufacturing process. Therefore, DNELs for the general population do not need to be derived.