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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:
other: Category specific approach
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:
Correction of NOAEL oral to inhaled: 1127*(1/0.38m3/kg)*(6.7m3/10m3)*1=1987 mg/m3
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1.5
Justification:
Exposure duration of the study does not have great impact on the NOAEL. A rat and dog 13 week, 26 week and 52 week studies have all NOAEL of around 1000 mg/kg bw. Time extrapolation for sub-chronic to chronic, has a default factor of 2. Given the evidence in two species, it is reasonable to deviate from the default factor of 2, and propose a specific LCA exposure duration factor of 1.5
AF for interspecies differences (allometric scaling):
1
Justification:
Oral to inhaled ECETOC default. Refer to Justification for interspecies difference
AF for other interspecies differences:
2
Justification:
Similar NOAELs indicate low variability between species. Dietary doses are adjusted for body weight differences during the study, hence allometry is implicit when comparing NOAELs from studies on two species. Since NOAELs in rat and dog studies are comparable, it is reasonable to assume that extrapolation to human will require a lower assessment factor. The default interspecies extrapolation factor for rat to human is 4, and 1.5 for dog. A specific LCA interspecies assessment factor of 2 is proposed.
AF for intraspecies differences:
3
Justification:
ECETOC default
AF for the quality of the whole database:
1
Justification:
Reliable studies
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short 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 extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
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: Category specific approach
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:
Oral NOAEL = corrected dermal NOAEL
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1.5
Justification:
Exposure duration of the study does not have great impact on the NOAEL. A rat and dog 13 week, 26 week and 52 week studies have all NOAEL of around 1000 mg/kg bw. Time extrapolation for sub-chronic to chronic, has a default factor of 2. Given the evidence in two species, it is reasonable to deviate from the default factor of 2, and propose a specific LCA exposure duration factor of 1.5
AF for interspecies differences (allometric scaling):
1
Justification:
Oral to dermal ECETOC default. Refer to Justification for interspecies difference
AF for other interspecies differences:
2
Justification:
Similar NOAELs indicate low variability between species. Dietary doses are adjusted for body weight differences during the study, hence allometry is implicit when comparing NOAELs from studies on two species. Since NOAELs in rat and dog studies are comparable, it is reasonable to assume that extrapolation to human will require a lower assessment factor. The default interspecies extrapolation factor for rat to human is 4, and 1.5 for dog. A specific LCA interspecies assessment factor of 2 is proposed.
AF for intraspecies differences:
3
Justification:
ECETOC default
AF for the quality of the whole database:
1
Justification:
Reliable studies
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short 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 extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
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:
low hazard (no threshold derived)

Additional information - workers

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, systemic effects, has been used instead. 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 deriving the Indicative Human No Effect Level (IHNEL) for LCA category. This study reported a NOAEL of 1127 mg/kg (bw).

In some cases the CAS and chemical identity stated refer to SDA nomenclature for this substance. in REACH substance identification it is necessary to be more specific as to the chain lengths present. Full details may be found in the CSR.

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: Category specific approach
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:
Correction of NOAEL oral to inhaled: 1127*(1/1.15m3/kg)*1=980 mg/m3
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1.5
Justification:
Exposure duration of the study does not have great impact on the NOAEL. A rat and dog 13 week, 26 week and 52 week studies have all NOAEL of around 1000 mg/kg bw. Time extrapolation for sub-chronic to chronic, has a default factor of 2. Given the evidence in two species, it is reasonable to deviate from the default factor of 2, and propose a specific LCA exposure duration factor of 1.5
AF for interspecies differences (allometric scaling):
1
Justification:
Oral to inhaled ECETOC default. Refer to Justification for interspecies difference
AF for other interspecies differences:
2
Justification:
Similar NOAELs indicate low variability between species. Dietary doses are adjusted for body weight differences during the study, hence allometry is implicit when comparing NOAELs from studies on two species. Since NOAELs in rat and dog studies are comparable, it is reasonable to assume that extrapolation to human will require a lower assessment factor. The default interspecies extrapolation factor for rat to human is 4, and 1.5 for dog. A specific LCA interspecies assessment factor of 2 is proposed.
AF for intraspecies differences:
5
Justification:
ECETOC default
AF for the quality of the whole database:
1
Justification:
Reliable studies
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short 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 extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
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: Category specific approach
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:
Oral NOAEL =corrected dermal NOAEL
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1.5
Justification:
Exposure duration of the study does not have great impact on the NOAEL. A rat and dog 13 week, 26 week and 52 week studies have all NOAEL of around 1000 mg/kg bw. Time extrapolation for sub-chronic to chronic, has a default factor of 2. Given the evidence in two species, it is reasonable to deviate from the default factor of 2, and propose a specific LCA exposure duration factor of 1.5
AF for interspecies differences (allometric scaling):
1
Justification:
Oral to dermal ECETOC default. Refer to Justification for interspecies difference
AF for other interspecies differences:
2
Justification:
Similar NOAELs indicate low variability between species. Dietary doses are adjusted for body weight differences during the study, hence allometry is implicit when comparing NOAELs from studies on two species. Since NOAELs in rat and dog studies are comparable, it is reasonable to assume that extrapolation to human will require a lower assessment factor. The default interspecies extrapolation factor for rat to human is 4, and 1.5 for dog. A specific LCA interspecies assessment factor of 2 is proposed.
AF for intraspecies differences:
5
Justification:
ECETOC default
AF for the quality of the whole database:
1
Justification:
Reliable studies
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Dermal
DNEL related information
DNEL extrapolated from long term DNEL

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
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: Category specific approach
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:
Oral NOAEL
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
1.5
Justification:
Exposure duration of the study does not have great impact on the NOAEL. A rat and dog 13 week, 26 week and 52 week studies have all NOAEL of around 1000 mg/kg bw. Time extrapolation for sub-chronic to chronic, has a default factor of 2. Given the evidence in two species, it is reasonable to deviate from the default factor of 2, and propose a specific LCA exposure duration factor of 1.5
AF for interspecies differences (allometric scaling):
1
Justification:
Oral to oral. Refer to Justification for interspecies difference
AF for other interspecies differences:
2
Justification:
Similar NOAELs indicate low variability between species. Dietary doses are adjusted for body weight differences during the study, hence allometry is implicit when comparing NOAELs from studies on two species. Since NOAELs in rat and dog studies are comparable, it is reasonable to assume that extrapolation to human will require a lower assessment factor. The default interspecies extrapolation factor for rat to human is 4, and 1.5 for dog. A specific LCA interspecies assessment factor of 2 is proposed.
AF for intraspecies differences:
5
Justification:
ECETOC default
AF for the quality of the whole database:
1
Justification:
Reliable studies
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short 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 extrapolated from long term DNEL

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

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 ¿systemic effects¿ has been used instead. 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 deriving the Indicative Human No Effect Level (IHNEL) for LCA category. This study reported a NOAEL of 1127 mg/kg (bw).

In some cases the CAS and chemical identity stated refer to SDA nomenclature for this substance. in REACH substance identification it is necessary to be more specific as to the chain lengths present. Full details may be found in the CSR.