Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide

Toxicological Summary

Workers - Hazard via inhalation route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

1.405 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):

75

Dose descriptor starting point:

NOAEL

Value:

59.8 mg/kg bw/day

Modified dose descriptor starting point:

NOAEC

Value:

105.4 mg/m³

Explanation for the modification of the dose descriptor starting point:

Good quality oral study available. While no siginificant inhalation exposure anticipated, it is possible to derive systemic NOAEC for this route using default assumptions and the oral data to extrapolate, as per ECHA guidance ("Guidance on information requirements and chemical safety assessment; Chapter R.8: Characterisation of dose [concentration]-response for human health.)

AF for dose response relationship:

1

Justification:

Adequate dosing and study information. No justification for deviating from the standard AF outlined in Ch R:8 based on the database.

AF for differences in duration of exposure:

6

Justification:

Sub-acute to chronic exposure

AF for interspecies differences (allometric scaling):

1

Justification:

No allometric scaling for inhalation route

AF for other interspecies differences:

2.5

Justification:

According to Chapter R.8-Dose [Concentration]-Response Regarding Human Health, an additional assessment factor of 2.5 should be applied for remaining differences between test species and human. In cases where differences are not related to basal metabolic rate, the assessment factor should be modified. In terms of dynamics, one might assume that animals and humans will respond in the same way (p. 33). Based on the physicochemical properties, absorption is believed to be limited to such a degree that metabolic differences are not relevant for remaining differences. for more details see systemic dermal DNELs.

AF for intraspecies differences:

5

Justification:

Standard default value for workers as indicated by the ECHA guidance document “Guidance on information requirements and chemical safety assessment; Chapter R.8: Characterisation of dose [concentration]-response for human health.

AF for the quality of the whole database:

1

Justification:

Reliable study, good quality database

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

Workers - Hazard via dermal route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.199 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):

300

Dose descriptor starting point:

NOAEL

Value:

59.8 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

59.8 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

As a conservative assumption the oral and dermal absorption is considered identical and therefore no modification to the dose descriptor is neccessary.

AF for dose response relationship:

1

Justification:

Default value in accordance with ECHA guidance- Chapter R.8

AF for differences in duration of exposure:

6

Justification:

DNEL is based on 28 days oral study

AF for interspecies differences (allometric scaling):

4

Justification:

DNEL is based on study conducted in rats

AF for other interspecies differences:

2.5

Justification:

Default value in accordance with ECHA guidance- Chapter R.8

AF for intraspecies differences:

5

Justification:

DNEL is calculated for workers

AF for the quality of the whole database:

1

Justification:

Default value in accordance with ECHA guidance- Chapter R.8

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:

no hazard identified

Additional information - workers

In accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8, Appendix R.8-8, DNELs for acute effects have not been derived as no acute adverse effects have been seen in any of the available studies. No inhalation data are available, inhalation DNELs for long term systemic exposure have been derived using extrapolation from the repeated dose oral study, it should however be noted that inhalation is not considered a relevant route of exposure given the physical-chemical properties of the material and its use pattern, both of which will mean exposure by the inhalation route will be negligible. A long-term dermal DNEL for systemic effects in workers of 0.33 mg/kg bw/day is proposed based on the repeated dose oral toxicity study in rats in which a NOAEL of 100 mg/kg bw/day was identified. This corrected to 59.8 mg/kg/day,as the sample used for toxicity testing contained 40.2% base oil.

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:

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:

no hazard identified

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

General Population - Hazard via oral route

Systemic effects

Long term exposure

Hazard assessment conclusion:

DNEL (Derived No Effect Level)

Value:

0.1 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):

600

Dose descriptor starting point:

NOAEL

Value:

59.8 mg/kg bw/day

Modified dose descriptor starting point:

NOAEL

Value:

59.8 mg/kg bw/day

Explanation for the modification of the dose descriptor starting point:

ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8, Appendix R.8-8 on Acute Toxicity states that a DNEL for acute toxicity is only necessary if "an acute toxicity hazard (leading to C&L) has been identified and there is a potential for high peak exposures". No acute toxicity hazard has been identified for the substance and, thus, no acute hazard classification is proposed. Consequently, in accordance with the ECHA guidance, an acute DN(M) EL is not required. Moreover, the physico-chemical properties of the substances confirm that there is negligible potential for inhalation of the substance.

AF for dose response relationship:

1

Justification:

Adequate dosing and study information. No justification for deviating from the standard AF outlined in Ch R:8 based on the database.

AF for differences in duration of exposure:

6

Justification:

Sub-acute to chronic exposure

AF for interspecies differences (allometric scaling):

4

Justification:

DNEL is based on study conducted in rats

AF for other interspecies differences:

2.5

Justification:

Default value in accordance with ECHA guidance- Chapter R.8

AF for intraspecies differences:

10

Justification:

DNEL is calculated for general population

AF for the quality of the whole database:

1

Justification:

Reliable study, good quality database

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

The registration material is only used in industrial settings, there are no consumer uses and therefore no potential for exposure to the general population. A long term oral DNEL has been calculated for the purposes of the man via the environment assessment in the chemical safety assessment. No long term inhalation DNEL has been calculated, as the physico-chemical properties of the registration substance (very low vapour pressure) mean that inhalation exposure to man via environment is not a relevant exposure route.