Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
220 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):
9
Modified dose descriptor starting point:
NOAEC
Value:
1 987 mg/m³
Explanation for the modification of the dose descriptor starting point:
There is no repeated dose inhalation data. Therefore the repeated dose oral data has been used.
AF for dose response relationship:
1
Justification:
Starting point is a NOAEL
AF for differences in duration of exposure:
1.5
Justification:
See justification and comments
AF for interspecies differences (allometric scaling):
2
Justification:
See justification and comments
AF for other interspecies differences:
1
Justification:
See justification and comments
AF for intraspecies differences:
3
Justification:
Workers, ECETOC value - see justification and comments
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
other toxicological threshold
Value:
125 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: See justification and comments
Overall assessment factor (AF):
9
Modified dose descriptor starting point:
NOAEL
Value:
1 127 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
There is no repeated dose dermal data. Therefore the repeated dose oral data has been used.
AF for dose response relationship:
1
Justification:
Starting point is a NOAEL
AF for differences in duration of exposure:
1.5
Justification:
See justification and comments
AF for interspecies differences (allometric scaling):
2
Justification:
See justification and comments
AF for other interspecies differences:
1
Justification:
See justification and comments
AF for intraspecies differences:
3
Justification:
Workers, ECETOC value - see justification and comments
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
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
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Alcohols, C20-30 (even numbered), is a UVCB substance that comprises several linear long chain alcohols, predominantly tetracosan-1-ol (C24), hexacosan-1-ol (C26), and octacosan-1-ol (C28). Together, these substances make up approximately 70% of the composition of Alcohols, C20-30 (even numbered). Other constituents include, to a much lesser extent, secondary long chain alcohols and complex mixtures of long chain carboxylate esters. On this basis, study data, where available, for each of the long chain alcohol constituents has been evaluated and considered together; this is consistent with the Category approach applied for Long Chain Alcohols (LCA) under REACH. In a conservative approach the most sensitive study result from the constituents of the LCA category have been identified and used to address the endpoint in question.

Chronic and sub-chronic toxicity studies have shown that long chain alcohols (LCA) are of low toxicity. Furthermore, combined repeated-dose studies with developmental endpoints, as well as reproductive and developmental studies showed no effects at the highest dose tested.

 

Rather than having separate values for the three endpoints, one endpoint for systemic effects has been used. Since the NOAELs do not vary greatly across the category, one key study has been chosen as being representative of the whole category.

 

C6, Hexanol, has been chosen as the category representative because shorter chain molecules are usually regarded as more toxic when compared to structural analogues with longer carbon chain lengths. The 13-week repeat dose study on 1-hexanol by (Sc. Assoc. 1966) has been used as the key study for the LCA category. This study reported a NOAEL of 1127 mg/kg (bw).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
65 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: See justification and comments
Overall assessment factor (AF):
15
Modified dose descriptor starting point:
NOAEC
Value:
980 mg/m³
Explanation for the modification of the dose descriptor starting point:
There is no repeated dose inhalation data. Therefore the repeated dose oral data has been used.
AF for dose response relationship:
1
Justification:
Starting point is a NOAEL
AF for differences in duration of exposure:
1.5
Justification:
See justification and comments
AF for interspecies differences (allometric scaling):
2
Justification:
See justification and comments
AF for other interspecies differences:
1
Justification:
See justification and comments
AF for intraspecies differences:
5
Justification:
General population, ECETOC value - see justification and comments
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information
Overall assessment factor (AF):
15
Modified dose descriptor starting point:
NOAEC

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:
other toxicological threshold
Value:
75 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: See justification and comments
Overall assessment factor (AF):
15
Modified dose descriptor starting point:
NOAEL
Value:
1 127 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
There is no repeated dose dermal data. Therefore the repeated dose oral data has been used.
AF for dose response relationship:
1
Justification:
Starting point is a NOAEL
AF for differences in duration of exposure:
1.5
Justification:
See justification and comments
AF for interspecies differences (allometric scaling):
2
Justification:
See justification and comments
AF for other interspecies differences:
1
Justification:
See justification and comments
AF for intraspecies differences:
5
Justification:
General population, ECETOC value - see justification and comments
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
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
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
75 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: See justification and comments
Overall assessment factor (AF):
15
Modified dose descriptor starting point:
NOAEL
Value:
1 127 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable
AF for dose response relationship:
1
Justification:
Starting point is a NOAEL
AF for differences in duration of exposure:
1.5
Justification:
See justification and comments
AF for interspecies differences (allometric scaling):
2
Justification:
See justification and comments
AF for other interspecies differences:
1
Justification:
See justification and comments
AF for intraspecies differences:
5
Justification:
General population, ECETOC value - see justification and comments
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population