Reaction product of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs. and Benzenesulfonic acid, 4-methyl- and sodium hydroxide

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

6 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):

25

Modified dose descriptor starting point:

NOAEC

Value:

149.9 mg/m³

Explanation for the modification of the dose descriptor starting point:

There is no reliable repeated dose inhalation data. For this substance it is unlikely that the toxicological profile is route dependent. Therefore the repeated dose oral data has been used. There are no exact absorption factors for oral and inhalative resorpiton available, therefore in conclusion it is expected that the absoption factors for both routes are 100 %. That means an additional AF for route-to-route is not required.

AF for dose response relationship:

1

Justification:

Starting point is a NOAEL

AF for differences in duration of exposure:

2

Justification:

Exposure duration (subchronic study)

AF for interspecies differences (allometric scaling):

1

Justification:

Not typically applied in the derivation of an inhalation DNEL.

AF for other interspecies differences:

2.5

Justification:

Default value

AF for intraspecies differences:

5

Justification:

worker

AF for the quality of the whole database:

1

Justification:

good qualitiy

AF for remaining uncertainties:

1

Justification:

No remaining uncertainties identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Most sensitive endpoint:

skin irritation/corrosion

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

85 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

Route of original study:

Oral

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

100

Modified dose descriptor starting point:

NOAEL

Value:

8 500 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

For long-term, worker, dermal exposures, the DNEL is derived using the oral NOAEL of the repeated dose study on LAS as the starting point. This oral NOAEL starting point value must then be corrected for route-to-route extrapolation for the dermal route. A study on LAS is used as starting point, therefore also the dermal absorption factor of LAS is used for calculating the dermal NOAEL. In this case it is more reasonable to use the LAS dermal factor and not the dermal absorption factor of hydrotropes because this study is the base of the calculation. Based on data from a dermal absorption study of a C12 LAS homologue in isolated human epidermis (Howes 1975) that indicated < 0.065% of the applied dose penetrated the skin in 48 hours, 1% dermal absorption is conservatively assumed. The dermal NOAEL is therefore 8500 mg/kg bw/day.

AF for dose response relationship:

1

Justification:

Starting point is a NOAEL

AF for differences in duration of exposure:

2

Justification:

eposure duration (subchronic to chronic)

AF for interspecies differences (allometric scaling):

4

Justification:

rat to human

AF for other interspecies differences:

2.5

Justification:

Default value

AF for intraspecies differences:

5

Justification:

worker

AF for the quality of the whole database:

1

Justification:

good quality

AF for remaining uncertainties:

1

Justification:

No remaining uncertainties identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Most sensitive endpoint:

skin irritation/corrosion

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

high hazard (no threshold derived)

Additional information - workers

There are no repeat dose studies with Marlon ARL, however, there are such studies for the major constituent (i.e., LAS). The acute toxicity of Marlon ARL and LAS are comparable, oral LD50s of 2240 and 1080 mg/kg respectively, and dermal LD50s of 2000 for each of the substances. LAS is therefore used as a read across substance, and the DNELs for long term exposure to workers and the general population are based on the highest NOAEL below the lowest LOAEL in repeated dose studies; 85 mg/kg bw/day (Yoneyama et al, 1976) in a 9-month exposure (systemic effects).

Yoneyama, M et al, 1976. Subacute toxicity of linear alkylbenzene sulfonate cited in IPCS. 1996. Environmental Health Criteria 169. LAS and related compounds. World Health Organization, Geneva, Switzerland.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

1.5 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):

50

Modified dose descriptor starting point:

NOAEC

Value:

79.3 mg/m³

Explanation for the modification of the dose descriptor starting point:

There is no reliable repeated dose inhalation data. For this substance it is unlikely that the toxicological profile is route dependent. Therefore the repeated dose oral data has been used. There are no exact absorption factors for oral and inhalative resorpiton available, therefore in conclusion it is expected that the absoption factors for both routes are 100 %. That means an additional AF for route-to-route is not required.

AF for dose response relationship:

1

Justification:

Starting point is a NOAEL

AF for differences in duration of exposure:

2

Justification:

Exposure duration (subchronic study)

AF for interspecies differences (allometric scaling):

1

Justification:

Not typically applied in the derivation of an inhalation DNEL.

AF for other interspecies differences:

2.5

Justification:

Default value

AF for intraspecies differences:

10

Justification:

worker

AF for the quality of the whole database:

1

Justification:

good quality

AF for remaining uncertainties:

1

Justification:

No remaining uncertainties identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Most sensitive endpoint:

skin irritation/corrosion

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:

42.5 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

200

Modified dose descriptor starting point:

NOAEL

Value:

8 500 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

For long-term, General Population, dermal exposures, the DNEL is derived using the oral NOAEL of the repeated dose study on LAS as the starting point. This oral NOAEL starting point value must then be corrected for route-to-route extrapolation for the dermal route. A study on LAS is used as starting point, therefore also the dermal absorption factor of LAS is used for calculating the dermal NOAEL. In this case it is more reasonable to use the LAS dermal factor and not the dermal absorption factor of hydrotropes because this study is the base of the calculation. Based on data from a dermal absorption study of a C12 LAS homologue in isolated human epidermis (Howes 1975) that indicated < 0.065% of the applied dose penetrated the skin in 48 hours, 1% dermal absorption is conservatively assumed. The dermal NOAEL is therefore 8500 mg/kg bw/day.

AF for dose response relationship:

1

Justification:

Starting point is a NOAEL

AF for differences in duration of exposure:

2

Justification:

Exposure duration (subchronic study)

AF for interspecies differences (allometric scaling):

4

Justification:

rat to human

AF for other interspecies differences:

2.5

Justification:

Default value

AF for intraspecies differences:

10

Justification:

general population

AF for the quality of the whole database:

1

Justification:

good quality

AF for remaining uncertainties:

1

Justification:

No remaining uncertainties identified

Acute/short term exposure

Hazard assessment conclusion:

no hazard identified

DNEL related information

Local effects

Long term exposure

Hazard assessment conclusion:

medium hazard (no threshold derived)

Most sensitive endpoint:

skin irritation/corrosion

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:

0.425 mg/kg bw/day

Most sensitive endpoint:

repeated dose toxicity

DNEL related information

DNEL derivation method:

ECHA REACH Guidance

Overall assessment factor (AF):

200

Modified dose descriptor starting point:

NOAEL

Value:

85 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

not route-to-route

AF for dose response relationship:

1

Justification:

Starting point is a NOAEL

AF for differences in duration of exposure:

2

Justification:

Exposure duration (subchronic study)

AF for interspecies differences (allometric scaling):

4

Justification:

rat to human

AF for other interspecies differences:

2.5

Justification:

Default value

AF for intraspecies differences:

10

Justification:

general population

AF for the quality of the whole database:

1

Justification:

good quality

AF for remaining uncertainties:

1

Justification:

No remaining uncertainties 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:

high hazard (no threshold derived)

Additional information - General Population

There are no repeat dose studies with Marlon ARL, however, there are such studies for the major constituent (i.e., LAS). The acute toxicity of Marlon ARL and LAS are comparable, oral LD50s of 2240 and 1080 mg/kg respectively, and dermal LD50s of 2000 for each of the substances. LAS is therefore used as a read across substance, and the DNELs for long term exposure to workers and the general population are based on the highest NOAEL below the lowest LOAEL in chronic studies; 85 mg/kg bw/day (Yoneyama et al, 1976) in a 9-month exposure (systemic effects).

Yoneyama, M et al, 1976. Subacute toxicity of linear alkylbenzene sulfonate cited in IPCS. 1996. Environmental Health Criteria 169. LAS and related compounds. World Health Organization, Geneva, Switzerland.