Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
32.9 mg/m³
Most sensitive endpoint:
effect on fertility
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:
1 000 mg/kg bw/day
Value:
2 470 mg/m³
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
2
Justification:
ECHA Guidance, route-to-route extrapolation (oral to inhalation)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.3 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
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:
1 000 mg/kg bw/day
Value:
7 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Default (DNEL calculator)

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
6
Justification:
Default (DNEL calculator)
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
1
Justification:
Default (DNEL calculator)
AF for remaining uncertainties:
1
Justification:
No relevant effect observed
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
no DNEL required: short term exposure controlled by conditions for long-term

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

Workers - Hazard via inhalation route

No route-specific acute and/or repeated inhalation toxicity data is available for the registration substance and/or for the read-across source molecule. As default, route-to-route extrapolation is performed using the NOAEL of 1000 mg/kg body weight per day from a OECD 421 reproductive toxicity screening study performed on the read-across substance SMOT. A NOAEL value of 1000 mg/kg bw/d was determined in this study. This NOAEL value of is used as starting point for the derivation of the worker DNEL "long-term inhalation exposure - systemic effects". The DNEL calculator integrated within IUCLID 6 v3.15.1 was used to automatically calculate DNEL for workers potentially exposed to the substance via the inahalation route.

Workers - Hazard via dermal route

Data from studies with the dermal route of exposure are available for the read-across source molecule sodium methyl oleyl taurate. Based on the LD50 of greater 2000 mg/kg body weight revealed in an acute dermal toxicity study, no concern with respect to acute dermal exposure is deducible for the registration substance. However, no route-specific repeated dermal toxicity data is available for the submission substance and/or the read-across source molecule. As default, route-to-route extrapolation is performed using the NOAEL of 1000 mg/kg body weight per day from an OECD 421 reproductive toxicity screening study performed on the read-across substance SMOT, which was identified as key study for reproductive toxicity for the registered substance. This NOAEL is used as starting point for the derivation of the worker DNEL "long-term dermal exposure - systemic effects". The DNEL calculator integrated within IUCLID 6 v3.15.1 was used to automatically calculate DNEL for workers potentially exposed to the substance via the dermal route.

Additional information

No DNELs are derived for acute systemic toxicity and for local effects following acute exposure. Based on the result from an available acute dermal toxicity study for the read-across substance SMOT resulting in an LD50 value greater 2000 mg/kg body weight, it is concluded that no risk is deducible for this exposure condition. It is further concluded that short-term exposures are well-controlled by conditions for long-term exposure. Additionally, proper technical and personal risk management measures are in place to protect against local effects and ensure safe use conditions.

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:
no hazard 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:
no hazard identified

Additional information - General Population

With regard to consumer exposure, the registered substance is used only in cosmetic products. Therefore, derivation of DNELs, assessment of exposure and risk characterization are not required under REACH. Safety assessment of these uses fall under the scope of Regulation (EC) 1223/2009 on cosmetic products. Hence, no DNELs for consumer exposure via the oral, inhalation or dermal routes have been derived.