Octan-1-ol

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

176 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Dermal

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

10

Modified dose descriptor starting point:

NOAEC

Value:

1 763 mg/m³

Explanation for the modification of the dose descriptor starting point:

The following correction was made to the NOAEL (dermal): Correction respiratory volume rat (8 hour) 1/0.38 m³/kg bw/day, Correction for respiratory volume (worker): 6.7 m³/10 m³. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: dermal 1000*(1/0.38) *(6.7 m³/10 m³) = 1763 mg/m³.

AF for dose response relationship:

1

Justification:

Default (starting point is NOAEL)

AF for differences in duration of exposure:

2

Justification:

Default (sub-chronic to chronic)

AF for interspecies differences (allometric scaling):

1

Justification:

Default (dermal to inhalation)

AF for other interspecies differences:

1

Justification:

The mammalian alcohol dehydrogenase system is a group of pathways which catalyse the conversion of alcohols and aldehydes, which includes different forms of the enzymes which vary in substrate specificity. The alcohol dehydrogenases (ADHs) are divided into six classes, denoted by ADH1-ADH6. Five of the six classes of alcohol dehydrogenase have been identified in humans. One of the classes, ADH3, is the ancestral form of all mammalian ADHs, and has been traced in all living species investigated. The alcohol dehydrogenase system is considered to be able to detoxify a wide range of alcohols and aldehydes without the generation of toxic radicals (Höög, J-O et al., 2001). Therefore the metabolism of of all category members would be expected to follow the same pathway in rats and humans so an interspecies assessment factor to account for potential differences in metabolic pathway is not required and a value of 1 is appropriate. Reference: Höög, J-O, Hedberg, J. J., Strömberg, P., Svensson, S. (2001). Mammalian alcohol dehydrogenase - Functional and structural implications. Journal of Biomedical Science Volume 8, Issue 1, pp 71-76

AF for intraspecies differences:

5

Justification:

Default (worker)

AF for the quality of the whole database:

1

Justification:

Default (guideline study)

AF for remaining uncertainties:

1

Justification:

An assessment factor for remaining uncertainties is not required on the basis of the toxicological results: no adverse systemic effects were observed in any of the numerous reliable systemic toxicity studies that have been conducted for different endpoints for a wide range of alcohols with carbon chain lengths from C6 to C22; observations were consistent across the category. Furthermore, humans and test species are considered to respond to exposure to exogenous fatty alcohols in a similar way. Aliphatic alcohols show a chain-length dependent potential for gastro-intestinal and dermal absorption, with shorter chain aliphatic alcohols having a higher absorption potential than longer chain alcohols. Following inhalation exposure, absorption could occur for lower chain length alcohols, while little systemic exposure would be expected for the higher carbon number alcohols, from C9 upwards. Absorbed aliphatic alcohols potentially could be widely distributed within the body (OECD, 2006). As a result of the rapid and efficient metabolism, it is not anticipated that aliphatic alcohols would remain in the body for any significant length of time. Long chain (LC) fatty alcohols are synthesised within cells and are therefore found within organisms and occur naturally in the environment. Endogenous and exogenous LC alcohols are metabolised in catabolic (breakdown) and anabolic (synthesis) pathways. Cellular metabolism can cycle between LC alcohols and their corresponding acids. Alcohols are used as building blocks in the synthesis of lipids for energy storage. It is therefore concluded that, should systemic exposure occur to anthropogenic LC alcohols, mammals including test species and humans share common pathways for their metabolism and the products of metabolism are naturally-occurring metabolites. The LC aliphatic carboxylic acids are efficiently eliminated and aliphatic alcohols are therefore not expected to have a tissue retention or bioaccumulation potential (Bevan, 2001).

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

106 mg/m³

Most sensitive endpoint:

irritation (respiratory tract)

DNEL related information

DNEL derivation method:

other: The German national maximum exposure limit (AGW) for octan-1-ol is 106 mg/m³.

Overall assessment factor (AF):

1

Dose descriptor:

NOAEC

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:

DNEL (Derived No Effect Level)

Value:

50 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Dermal

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

40

Modified dose descriptor starting point:

NOAEL

Value:

2 000 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

No modification necessary, dermal rat to dermal human. 50% dermal uptake in intact human skin has been taken into account. Dermal absorption following exposure to intact skin in non-occlusive conditions (as expected following exposure) is expected to be similar in animals and humans. However, in the 90-day repeat dose study with fatty alcohol blend, desquamation was observed in all treated animals by day 6, other dermal effects included fissuring, exfoliation, eschar and clear exudate were also observed. These effects indicate that the normal barrier to absorption had broken down and absorption is therefore assumed to be 100%.  50% dermal absorption in humans is assumed (refer to Section 7.1 of the IUCLID dossier).

AF for dose response relationship:

1

Justification:

Default (starting point is NOAEL).

AF for differences in duration of exposure:

2

Justification:

Default (sub-chronic to chronic).

AF for interspecies differences (allometric scaling):

4

Justification:

Default (dermal to dermal).

AF for other interspecies differences:

1

Justification:

The mammalian alcohol dehydrogenase system is a group of pathways which catalyse the conversion of alcohols and aldehydes, which includes different forms of the enzymes which vary in substrate specificity. The alcohol dehydrogenases (ADHs) are divided into six classes, denoted by ADH1-ADH6. Five of the six classes of alcohol dehydrogenase have been identified in humans. One of the classes, ADH3, is the ancestral form of all mammalian ADHs, and has been traced in all living species investigated. The alcohol dehydrogenase system is considered to be able to detoxify a wide range of alcohols and aldehydes without the generation of toxic radicals (Höög, J-O et al., 2001). Therefore the metabolism of all category members would be expected to follow the same pathway in rats and humans so an interspecies assessment factor to account for potential differences in metabolic pathway is not required and a value of 1 is appropriate. Reference: Höög, J-O, Hedberg, J. J., Strömberg, P., Svensson, S. (2001). Mammalian alcohol dehydrogenase - Functional and structural implications. Journal of Biomedical Science Volume 8, Issue 1, pp 71-76

AF for intraspecies differences:

5

Justification:

Default (worker)

AF for the quality of the whole database:

1

Justification:

Default (guideline study)

AF for remaining uncertainties:

1

Justification:

An assessment factor for remaining uncertainties is not required on the basis of the toxicological results: no adverse systemic effects were observed in any of the numerous reliable systemic toxicity studies that have been conducted for different endpoints for a wide range of alcohols with carbon chain lengths from C6 to C22; observations were consistent across the category. Furthermore, humans and test species are considered to respond to exposure to exogenous fatty alcohols in a similar way. Aliphatic alcohols show a chain-length dependant potential for gastro-intestinal and dermal absorption, with shorter chain aliphatic alcohols having a higher absorption potential than longer chain alcohols. Following inhalation exposure, absorption could occur for lower chain length alcohols, while little systemic exposure would be expected for the higher carbon number alcohols, from C9 upwards. Absorbed aliphatic alcohols potentially could be widely distributed within the body (OECD, 2006). As a result of the rapid and efficient metabolism, it is not anticipated that aliphatic alcohols would remain in the body for any significant length of time. Long chain (LC) fatty alcohols are synthesised within cells and are therefore found within organisms and occur naturally in the environment. Endogenous and exogenous LC alcohols are metabolised in catabolic (breakdown) and anabolic (synthesis) pathways. Cellular metabolism can cycle between LC alcohols and their corresponding acids. Alcohols are used as building blocks in the synthesis of lipids for energy storage. It is therefore concluded that, should systemic exposure occur to anthropogenic LC alcohols, mammals including test species and humans share common pathways for their metabolism and the products of metabolism are naturally-occurring metabolites. The LC aliphatic carboxylic acids are efficiently eliminated and aliphatic alcohols are therefore not expected to have a tissue retention or bioaccumulation potential (Bevan, 2001).

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

190 µg/cm²

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

15

Dose descriptor:

other: LOAEL

AF for dose response relationship:

3

Justification:

Use of LOAEL. The LOAEL is the lowest tested level. The responses are very variable with no obvious dose response or duration response. Individual animals appear to have variable sensitivity and there are no consistent patterns.

AF for differences in duration of exposure:

1

Justification:

Local effect, so no correction for duration is applicable.

AF for interspecies differences (allometric scaling):

1

Justification:

Default (local effects).

AF for other interspecies differences:

1

Justification:

Default (local effects).

AF for intraspecies differences:

5

Justification:

Default (workers).

AF for the quality of the whole database:

1

Justification:

Default (guideline study).

AF for remaining uncertainties:

1

Justification:

Default (no remaining uncertainties).

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

low hazard (no threshold derived)

Additional information - workers

Discussion

In summary of the toxicological properties of octan-1-ol:

Acute toxicity tests of octan-1-ol do not indicate any potential hazard for acute, dermal or inhalation toxicity, and would not be classified for acute toxicity endpoint under DSD or Regulation 1272/2008 (CLP).

Octan-1-ol is classified as an eye irritant (Cat 2) but is not irritating to skin. Nor is it sensitising by skin contact.

Octan-1-ol is not classified for repeated dose toxicity effects (STOT-RE) or for reproductive toxicity.

In vitro and in vivo studies indicate that octan-1-ol is not genotoxic.

In summary, octan-1-ol is classified as an eye irritant under Regulation 1272/2008 (CLP).

On the basis of the toxicological results for octan-1-ol no adverse systemic effects were observed in any of the numerous systemic toxicity studies that have been conducted for the different endpoints. Nevertheless, systemic DNEL values have been derived for systemic effects based on the highest dose tested. The DNELs are therefore indicative only and are derived as a precautionary approach to enable quantitative risk assessment with overestimation in RMM.

There is some evidence that local dermal effects occur in test animals, although octan-1-ol does not require classification for dermal irritation in humans. DNEL values for dermal long term local effects have been derived.

The German regulatory authority imposes a statutory national workplace limit concentration of several analogous alcohols in air in industrial workplaces (AGW); the value set for octan-1-ol is 106 mg/m³.

Overall it would however be prudent to recommend the precautionary use of gloves. Studies indicate that octan-1-ol is irritating to eyes. However, a DNEL for this endpoint cannot be derived and therefore quantitative risk characterisation is not possible. Instead qualitative risk characterisation is required and risk management measures (such as the limitation of concentration in consumer formulations) to minimise any potential eye contact would be required.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

43.5 mg/m³

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Dermal

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

20

Modified dose descriptor starting point:

NOAEC

Value:

870 mg/m³

Explanation for the modification of the dose descriptor starting point:

The following correction was made to the NOAEL (dermal): Correction respiratory volume rat (8 hour) 1/1.15 m3/kg bw/day. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: dermal 1000*(1/1.15) = 870 mg/m3.

AF for dose response relationship:

1

Justification:

Default (starting point is NOAEL).

AF for differences in duration of exposure:

2

Justification:

Default (sub-chronic to chronic).

AF for interspecies differences (allometric scaling):

1

Justification:

Default (dermal to inhalation).

AF for other interspecies differences:

1

Justification:

The mammalian alcohol dehydrogenase system is a group of pathways which catalyse the conversion of alcohols and aldehydes, which includes different forms of the enzymes which vary in substrate specificity. The alcohol dehydrogenases (ADHs) are divided into six classes, denoted by ADH1-ADH6. Five of the six classes of alcohol dehydrogenase have been identified in humans. One of the classes, ADH3, is the ancestral form of all mammalian ADHs, and has been traced in all living species investigated. The alcohol dehydrogenase system is considered to be able to detoxify a wide range of alcohols and aldehydes without the generation of toxic radicals (Höög, J-O et al., 2001). Therefore the metabolism of all category members would be expected to follow the same pathway in rats and humans so an interspecies assessment factor to account for potential differences in metabolic pathway is not required and a value of 1 is appropriate. Reference: Höög, J-O, Hedberg, J. J., Strömberg, P., Svensson, S. (2001). Mammalian alcohol dehydrogenase - Functional and structural implications. Journal of Biomedical Science Volume 8, Issue 1, pp 71-76 .

AF for intraspecies differences:

10

Justification:

Default (general population).

AF for the quality of the whole database:

1

Justification:

Default (guideline study).

AF for remaining uncertainties:

1

Justification:

An assessment factor for remaining uncertainties is not required on the basis of the toxicological results: no adverse systemic effects were observed in any of the numerous reliable systemic toxicity studies that have been conducted for different endpoints for a wide range of alcohols with carbon chain lengths from C6 to C22; observations were consistent across the category. Furthermore, humans and test species are considered to respond to exposure to exogenous fatty alcohols in a similar way. Aliphatic alcohols show a chain-length dependant potential for gastro-intestinal and dermal absorption, with shorter chain aliphatic alcohols having a higher absorption potential than longer chain alcohols. Following inhalation exposure, absorption could occur for lower chain length alcohols, while little systemic exposure would be expected for the higher carbon number alcohols, from C9 upwards. Absorbed aliphatic alcohols potentially could be widely distributed within the body (OECD, 2006). As a result of the rapid and efficient metabolism, it is not anticipated that aliphatic alcohols would remain in the body for any significant length of time. Long chain (LC) fatty alcohols are synthesised within cells and are therefore found within organisms and occur naturally in the environment. Endogenous and exogenous LC alcohols are metabolised in catabolic (breakdown) and anabolic (synthesis) pathways. Cellular metabolism can cycle between LC alcohols and their corresponding acids. Alcohols are used as building blocks in the synthesis of lipids for energy storage. It is therefore concluded that, should systemic exposure occur to anthropogenic LC alcohols, mammals including test species and humans share common pathways for their metabolism and the products of metabolism are naturally-occurring metabolites. The LC aliphatic carboxylic acids are efficiently eliminated and aliphatic alcohols are therefore not expected to have a tissue retention or bioaccumulation potential (Bevan, 2001).

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:

DNEL (Derived No Effect Level)

Value:

25 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Dermal

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

80

Modified dose descriptor starting point:

NOAEL

Value:

2 000 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

No modification necessary, dermal rat to dermal human. 50% dermal uptake in intact human skin has been taken into account. Dermal absorption following exposure to intact skin in non-occlusive conditions (as expected following exposure) is expected to be similar in animals and humans. However, in the 90-day repeat dose study with fatty alcohol blend, desquamation was observed in all treated animals by day 6, other dermal effects included fissuring, exfoliation, eschar and clear exudate were also observed. These effects indicate that the normal barrier to absorption had broken down and absorption is therefore assumed to be 100%. 50% dermal absorption in humans is assumed (refer to Section 7.1 of the IUCLID dossier).

AF for dose response relationship:

1

Justification:

Default (starting point is NOAEL).

AF for differences in duration of exposure:

2

Justification:

Default (sub-chronic to chronic).

AF for interspecies differences (allometric scaling):

4

Justification:

Default (dermal to dermal).

AF for other interspecies differences:

1

Justification:

The mammalian alcohol dehydrogenase system is a group of pathways which catalyse the conversion of alcohols and aldehydes, which includes different forms of the enzymes which vary in substrate specificity. The alcohol dehydrogenases (ADHs) are divided into six classes, denoted by ADH1-ADH6. Five of the six classes of alcohol dehydrogenase have been identified in humans. One of the classes, ADH3, is the ancestral form of all mammalian ADHs, and has been traced in all living species investigated. The alcohol dehydrogenase system is considered to be able to detoxify a wide range of alcohols and aldehydes without the generation of toxic radicals (Höög, J-O et al., 2001). Therefore the metabolism of all category members would be expected to follow the same pathway in rats and humans so an interspecies assessment factor to account for potential differences in metabolic pathway is not required and a value of 1 is appropriate. Reference: Höög, J-O, Hedberg, J. J., Strömberg, P., Svensson, S. (2001). Mammalian alcohol dehydrogenase - Functional and structural implications. Journal of Biomedical Science Volume 8, Issue 1, pp 71-76

AF for intraspecies differences:

10

Justification:

Default (general population).

AF for the quality of the whole database:

1

Justification:

Default (guideline study).

AF for remaining uncertainties:

1

Justification:

An assessment factor for remaining uncertainties is not required on the basis of the toxicological results: no adverse systemic effects were observed in any of the numerous reliable systemic toxicity studies that have been conducted for different endpoints for a wide range of alcohols with carbon chain lengths from C6 to C22; observations were consistent across the category. Furthermore, humans and test species are considered to respond to exposure to exogenous fatty alcohols in a similar way. Aliphatic alcohols show a chain-length dependant potential for gastro-intestinal and dermal absorption, with shorter chain aliphatic alcohols having a higher absorption potential than longer chain alcohols. Following inhalation exposure, absorption could occur for lower chain length alcohols, while little systemic exposure would be expected for the higher carbon number alcohols, from C9 upwards. Absorbed aliphatic alcohols potentially could be widely distributed within the body (OECD, 2006). As a result of the rapid and efficient metabolism, it is not anticipated that aliphatic alcohols would remain in the body for any significant length of time. Long chain (LC) fatty alcohols are synthesised within cells and are therefore found within organisms and occur naturally in the environment. Endogenous and exogenous LC alcohols are metabolised in catabolic (breakdown) and anabolic (synthesis) pathways. Cellular metabolism can cycle between LC alcohols and their corresponding acids. Alcohols are used as building blocks in the synthesis of lipids for energy storage. It is therefore concluded that, should systemic exposure occur to anthropogenic LC alcohols, mammals including test species and humans share common pathways for their metabolism and the products of metabolism are naturally-occurring metabolites. The LC aliphatic carboxylic acids are efficiently eliminated and aliphatic alcohols are therefore not expected to have a tissue retention or bioaccumulation potential (Bevan, 2001).

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

67 µg/cm²

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

30

Dose descriptor:

other: LOAEL

AF for dose response relationship:

3

Justification:

Use of LOAEL. The LOAEL is the lowest tested level. The responses are very variable with no obvious dose response or duration response. Individual animals appear to have variable sensitivity and there are no consistent patterns.

AF for differences in duration of exposure:

1

Justification:

Local effect, so no correction for duration is applicable.

AF for interspecies differences (allometric scaling):

1

Justification:

Default (local effects).

AF for other interspecies differences:

1

Justification:

Default (local effects).

AF for intraspecies differences:

10

Justification:

Default (general population)

AF for the quality of the whole database:

1

Justification:

Default (guideline study).

AF for remaining uncertainties:

1

Justification:

Default (no remaining uncertainties).

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

12.5 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Dermal

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

80

Modified dose descriptor starting point:

NOAEL

Value:

1 000 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

No modification necessary.

AF for dose response relationship:

1

Justification:

Default (starting point is NOAEL).

AF for differences in duration of exposure:

2

Justification:

Default (sub-chronic to chronic).

AF for interspecies differences (allometric scaling):

4

Justification:

Default (dermal to oral).

AF for other interspecies differences:

1

Justification:

The mammalian alcohol dehydrogenase system is a group of pathways which catalyse the conversion of alcohols and aldehydes, which includes different forms of the enzymes which vary in substrate specificity. The alcohol dehydrogenases (ADHs) are divided into six classes, denoted by ADH1-ADH6. Five of the six classes of alcohol dehydrogenase have been identified in humans. One of the classes, ADH3, is the ancestral form of all mammalian ADHs, and has been traced in all living species investigated. The alcohol dehydrogenase system is considered to be able to detoxify a wide range of alcohols and aldehydes without the generation of toxic radicals (Höög, J-O et al., 2001). Therefore the metabolism of all category members would be expected to follow the same pathway in rats and humans so an interspecies assessment factor to account for potential differences in metabolic pathway is not required and a value of 1 is appropriate. Reference: Höög, J-O, Hedberg, J. J., Strömberg, P., Svensson, S. (2001). Mammalian alcohol dehydrogenase - Functional and structural implications. Journal of Biomedical Science Volume 8, Issue 1, pp 71-76 .

AF for intraspecies differences:

10

Justification:

Default (general population).

AF for the quality of the whole database:

1

Justification:

Default (guideline study).

AF for remaining uncertainties:

1

Justification:

An assessment factor for remaining uncertainties is not required on the basis of the toxicological results: no adverse systemic effects were observed in any of the numerous reliable systemic toxicity studies that have been conducted for different endpoints for a wide range of alcohols with carbon chain lengths from C6 to C22; observations were consistent across the category. Furthermore, humans and test species are considered to respond to exposure to exogenous fatty alcohols in a similar way. Aliphatic alcohols show a chain-length dependant potential for gastro-intestinal and dermal absorption, with shorter chain aliphatic alcohols having a higher absorption potential than longer chain alcohols. Following inhalation exposure, absorption could occur for lower chain length alcohols, while little systemic exposure would be expected for the higher carbon number alcohols, from C9 upwards. Absorbed aliphatic alcohols potentially could be widely distributed within the body (OECD, 2006). As a result of the rapid and efficient metabolism, it is not anticipated that aliphatic alcohols would remain in the body for any significant length of time. Long chain (LC) fatty alcohols are synthesised within cells and are therefore found within organisms and occur naturally in the environment. Endogenous and exogenous LC alcohols are metabolised in catabolic (breakdown) and anabolic (synthesis) pathways. Cellular metabolism can cycle between LC alcohols and their corresponding acids. Alcohols are used as building blocks in the synthesis of lipids for energy storage. It is therefore concluded that, should systemic exposure occur to anthropogenic LC alcohols, mammals including test species and humans share common pathways for their metabolism and the products of metabolism are naturally-occurring metabolites. The LC aliphatic carboxylic acids are efficiently eliminated and aliphatic alcohols are therefore not expected to have a tissue retention or bioaccumulation potential (Bevan, 2001).

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:

low hazard (no threshold derived)

Additional information - General Population

In summary of the toxicological properties of octan-1-ol:

Acute toxicity tests of octan-1-ol do not indicate any potential hazard for acute, dermal or inhalation toxicity, and would not be classified for acute toxicity endpoint under DSD or Regulation 1272/2008 (CLP).

Octan-1-ol is classified as an eye irritant (Cat 2) but is not irritating to skin. Nor is it sensitising by skin contact.

Octan-1-ol is not classified for repeated dose toxicity effects (STOT-RE) or for reproductive toxicity.

In vitro and in vivo studies indicate that octan-1-ol is not genotoxic.

In summary, octan-1-ol is classified as an eye irritant under Regulation 1272/2008 (CLP).

On the basis of the toxicological results for octan-1-ol no adverse systemic effects were observed in any of the numerous systemic toxicity studies that have been conducted for the different endpoints. Nevertheless, systemic DNEL values have been derived for systemic effects based on the highest dose tested. There is some evidence that local dermal effects occur in test animals, although octan-1-ol does not require classification for dermal irritation in humans. DNEL values for dermal long term local effects have been derived.

Overall it would however be prudent to recommend the precautionary use of gloves. Studies indicate that octan-1-ol is irritating to eyes. However, a DNEL for this endpoint cannot be derived and therefore quantitative risk characterisation is not possible. Instead qualitative risk characterisation is required and risk management measures (such as the limitation of concentration in consumer formulations) to minimise any potential eye contact would be required.