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:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
hazard unknown (no further information necessary)
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

2-Tetradecyloctadecan-1-ol has a very low vapour pressure, so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur.

According to data of the structural analogues the oral and dermal LD50 of 2 -tetradcyloctadecan-1 -ol is > 2000 mg/kg bodyweight. Therefore the substance is practically nontoxic after short-term exposure and a DNEL after short-time exposure must not to be derived. There was no evidence of toxicity after oral gavage administration of up to 1 ml/kg bw/d of the structural analogue 2 -octyldodecan-1 -ol for at least 90 consecutive days to rats. Based on these results, the NOAEL was considered to be at least 1000 mg/kg bw/d. Therefore no hazard is expected and no DNEL has to be derived for longterm systemic effects.

As the substabce is not irritant to the skin and eyes no local DNELs were 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:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
hazard unknown (no further information necessary)
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

2-Tetradecyloctadecan-1-ol has a very low vapour pressure, so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur.

According to data of the structural analogues the oral and dermal LD50 of 2 -tetradcyloctadecan-1 -ol is > 2000 mg/kg bodyweight. Therefore the substance is practically nontoxic after short-term exposure and a DNEL after short-time exposure must not to be derived. There was no evidence of toxicity after oral gavage administration of up to 1 ml/kg bw/d of the structural analogue 2 -octyldodecan-1 -ol for at least 90 consecutive days to rats. Based on these results, the NOAEL was considered to be at least 1000 mg/kg bw/d. Therefore no hazard is expected and no DNEL has to be derived for longterm systemic effects.

As the substabce is not irritant to the skin and eyes no local DNELs were derived.