Registration Dossier

Administrative data

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
Dose descriptor starting point:
NOAEL
DNEL value:
85 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
149.9 mg/m³
AF for dose response relationship:
1
Justification:
no other uncertainties
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
Justification:
incorporated in the calculation of the corrected inhalation NOAEC
AF for other interspecies differences:
2.5
Justification:
toxicokinetic/toxicodynamic differences
AF for intraspecies differences:
5
Justification:
DNEL derived for workers
AF for the quality of the whole database:
1
Justification:
the database is complete
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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
Dose descriptor starting point:
NOAEL
DNEL value:
85 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
8 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

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.

AF for dose response relationship:
1
Justification:
no other uncertainties
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to humans
AF for other interspecies differences:
2.5
Justification:
toxicokinetic/toxicodynamic differences
AF for intraspecies differences:
5
Justification:
DNEL for workers
AF for the quality of the whole database:
1
Justification:
the data base is sufficient
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 but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

LAB Sulfonic Acids are used as intermediates in the production of LAS. In many, but not all, cases the intermediates are site limited,i.e., they remain on the production facility for use in the LAS production process. In some cases the intermediates are sold to outside LAS manufacturers. Transport to these off-site facilities is conducted following strict health and safety procedures and DOT requirements.

All processing of LAB and LAB sulfonic acids takes place in closed systems that significantly minimize worker exposure. Workers also wear standard personal protective equipment including safety goggles, face shields, safety shoes, impervious nitrile gloves, long sleeved clothing, and rubber boots. Workers may also employ cartridge-type respirators equipped with organic vapor cartridges and acid-resistant suits, for example, during steaming and washing. The closed production process and use of personal protective equipment effectively eliminates exposure to production workers. Un-ionized LAB Sulfonic Acid is not present after neutralization during manufacture of LAS detergent products. Consumer exposure to trace levels of LAB Sulfonic Acids from detergent use is possible.

Extensive engineering controls are in place to minimize releases to the environment. These controls include SO2/SO3monitoring devices, spill containment dikes for rail unloading, leak inspections, high level tank alarms, and auto shut off valves. Emissions controls include line cyclones, electrostatic precipitation and passing through caustic scrubbers and scrubbing demisters. Some process wastewater is deep well injected. These practices and controls effectively reduce LAB Sulfonic Acid releases to the environment to levels far below the allowable amounts, as shown by process stack monitoring.

Because LAB Sulfonic Acids are intermediates in the production of LAS, the derivation of DNELs is performed using the data for LAS where appropriate and the data for LAB Sulfonic Acids where available. LAS is used in light-duty liquid dishwashing compounds, heavy-duty liquid and powder laundry detergents, all-purpose cleaners and industrial cleaners. Industrial cleaning professionals and consumers may be exposed to small amounts of LAB Sulfonic Acid contained in these products. Given these uses, and as recommended in Chapter R.8 of the REACH guidance documents, long-term DNELs were derived for workers potentially exposed through the dermal  and inhalation routes of exposure and for consumers through the oral, dermal and inhalation routes of exposure. As noted in R.8, β€œfor most substances and exposure scenarios the DNELlong-term will be sufficient for controlling risks.”

Overall, LAB Sulfonic Acids show relatively low toxicity, with an acute oral LD50 of 1470 mg/kg and no effects observed in acute dermal testing. Undiluted LAB Sulfonic Acid is irritating to the skin and eyes and is classified under the CLP as category 1 skin corrosive, eye severely irritating. LAB Sulfonic Acid is not a skin sensitizer and is not mutagenic. Effects in long-term repeated dose studies conducted on LAS and lasting up to 9 months (subchronic studies) are related to enzymatic, body and organ weight reductions but not mortality. No significant reproductive or developmental effects were observed in long-term testing with LAS. The most appropriate NOAEL from the long-term oral repeated dose toxicity test (85 mg/kg based on decreases in enzymatic activity in the 145 mg/kg bw/d dose in the Yoneyama et al. 1976 study) is the value used as a starting point for deriving the DNELlong-term, oral ,the DNELlong-term, dermal, and the DNELlong-term, inhalation, as appropriate, for worker and consumer exposures. The NOAEL of 85 mg/kg is most appropriate because it is the highest NOAEL below the lowest LOAEL in long-term studies.

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
Dose descriptor starting point:
NOAEL
DNEL value:
85 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
73.9 mg/m³
AF for dose response relationship:
1
Justification:
no other uncertainties
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
Justification:
incorporated in the corrected inhalation NOAEC
AF for other interspecies differences:
2.5
Justification:
toxicokinetic/toxicodynamic differences
AF for intraspecies differences:
10
Justification:
DNEL for the general population
AF for the quality of the whole database:
1
Justification:
the data base is sufficient
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
DNEL value:
85 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
DNEL value:
8 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

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.

AF for dose response relationship:
1
Justification:
no other uncertainties
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to humans
AF for other interspecies differences:
2.5
Justification:
toxicokinetic/toxicodynamic differences
AF for intraspecies differences:
10
Justification:
DNEL for general population
AF for the quality of the whole database:
1
Justification:
the data base is sufficient
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
DNEL value:
85 mg/kg bw/day
AF for dose response relationship:
1
Justification:
no other uncertainties
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to humans
AF for other interspecies differences:
2.5
Justification:
toxicokinetic/toxicodynamic differences
AF for intraspecies differences:
10
Justification:
DNEL for general population
AF for the quality of the whole database:
1
Justification:
the data base is sufficient
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population