Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
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:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
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:
2.8 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
1
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.8 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
1
Dose descriptor starting point:
other: NOAEL

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

The available toxicological data on sec-alkane sulfonate-sodium salts SAS allow the derivation of DNELs taking chronic toxicity studies with oral and dermal route of exposure into account. Due to the physico-chemical properties as well as toxicological aspects the following critical DNELs have been identified:

- DNEL short-term, dermal, local

- DNEL long-term, dermal, systemic

- DNEL long-term, inhalation, systemic

- DNEL long-term, dermal, local

DNELs for acute systemic dermal as well as acute systemic inhalation effects were not assessed as actual peak exposure levels are not exceeding the long-term DNELs. Additionally, no DNEL was derived for local effects following short-term and long-term inhalation exposure since peak exposure levels can be excluded for sec-alkane sulfonates-sodium salts SAS due to its hygroscopic nature and the DNEL long-term inhalation for systemic effects will sufficiently protect also against local effects. For the conclusion about the appropriateness of the assessment factors used for the derivation of the remaining DNELs regarding workers, the following aspects were considered and adjustments were made to characterize for uncertainty and variability when considered appropriate:

- overall confidence in the data base:

The data taken into account have been evaluated with regard to their reliability, relevance and completeness. Based hereupon no indications exist to assume limited reliability and/or a special extent of uncertainty of the data base.

- intra- and interspecies variation:

Corrections are made for potential intra- and interspecies differences between laboratory animals and humans using allometric scaling when appropriate taking the toxicokinetic and/or toxicodynamic characteristics of sec-alkane sulfonate-sodium salts SAS into account. Since the critical effects are primarily driven by concentration dependent irritation/inflammation reactions, adjustments mainly confine to the inhalative route of exposure.

- duration and route of exposure:

Extrapolation factors of 1 covering route to route as well as duration were taken into account for the inhalation scenarios long-term inhalation systemic (route-to-route) since the underlying NO(A)EL is coming from a chronic toxicity study.

- nature and severity of effects:

The observed adverse effects in animals are primarily driven by the irritative nature of aqueous sec-alkane sulfonates-sodium salts SAS and characterized as portal of entry effects. No further kinetic considerations apply. However, an additional uncertainty factor to account for potential sensitivity differences in irritation of 2 has been taken into account for long-term systemic inhalation.

- dose-response relationship:

There is no reason to assume special concern. Dose-response relationship with regard to special target organ toxicity which has to be taken into account was not observed.

- differences in exposure (route, duration, frequency, and pattern):

The route-to-route extrapolation for inhalative exposure is based on a NOAEL derived from a chronic one-year oral toxicity study. The starting point for inhalation assessment includes a correction for the respiratory volume of workers under light activity. Allometric scaling was not performed for the oral to inhalation extrapolation. An additional assessment factor of 2 to account for route to route was not applied as no indication of significant differences in the absorption rate exists. Concerning the dermal route of exposure a conservative assessment factor of 2 is used to account for duration extrapolation although not supported by data from chronic dermal exposure of mice. No additional assessment factors are used.

- other factors:

In cases where an aqueous solution of sec-alkane sulfonate-sodium salts SAS 93% was used as test substance, a correction was made to account for 100% sec-alkane sulfonate-sodium salts SAS. To account for potential differences in sensory irritation an additional factor of 2 was used. There are no other factors known that might require a particular margin of safety.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
14
Modified dose descriptor starting point:
NOAEC
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:
3.57 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
56
Modified dose descriptor starting point:
NOAEL
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:
2.8 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
1
Dose descriptor:
other: NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.8 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
1
Dose descriptor starting point:
other: NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.1 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
28
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

DNEL derivations were confined to the dermal exposure route as predominant and to long-term systemic oral exposure due to potential occasional ingestion. All other routes are not assessed due to negligible exposure potential as well as the low amounts of sec-alkane sulfonate-sodium salts SAS used in consumer products. DNELs for the general population with regard to inhalation exposure needed not to be assessed given the very low exposure potential against sec-alkane sulfonate-sodium salts SAS in consumer products by inhalation due to the low weight fractions and contact times expected. However, following worst case scenarios a DNEL for long-term, systemic, inhalation effects was derived. For the conclusion about the appropriateness of the assessment factors used for the derivation of DNELs regarding the general population the same aspects as above are taken into account. However, a default assessment factor of 7 for the general population instead of 5 for worker (taken as overall intraspecies variability assessment factor) was used to account for additional variability in sensitivity due to biological factors such as age, gender and health status. No further modifications were necessary taken the nature of effects into account as well as the limited exposure conditions of the general public through dilute formulations only.