Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
58.77 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):
30
Modified dose descriptor starting point:
NOAEC
Value:
1 763.16 mg/m³
Explanation for the modification of the dose descriptor starting point:

No study on long term inhalation toxicity available.

AF for dose response relationship:
1
Justification:
reliable dose-response, point of departure (POD) is NOAEL (no adverse systemic effects observed)
AF for differences in duration of exposure:
6
Justification:
sub-aute (28-day repeated dose) to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
not necessary for inhalation
AF for other interspecies differences:
1
Justification:
no adverse systemic effects observed, ADME (see Chapter on "Toxicokinetics") suggests no significant interspecies differences
AF for intraspecies differences:
5
Justification:
default for worker
AF for the quality of the whole database:
1
Justification:
good quality data
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:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.33 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):
120
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No study on long term dermal toxicity available.

AF for dose response relationship:
1
Justification:
reliable dose-response, POD is NOAEL (no adverse systemic effects observed)
AF for differences in duration of exposure:
6
Justification:
sub-acute (28-day repeated dose) to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
the study was conducted with rats
AF for other interspecies differences:
1
Justification:
no adverse systemic effects observed, ADME (see Chapter on "Toxicokinetics") suggests no significant interspecies differences
AF for intraspecies differences:
5
Justification:
default for worker
AF for the quality of the whole database:
1
Justification:
good quality data
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

Important note:

Pursuant to ECHA decision CCH-D-2114394004-54-01/F (issued 22 March 2018) data on sub-acute and sub-chronic oral repeated dose toxicity according to OECD guideline 422 and OECD guideline 408, respectively, as well as data on prenatal developmental toxicity in rats according to OECD guideline 414 are currently being performed. Depending on the results of the prenatal developmental toxicity study in rats, a prenatal developmental toxicity study in a second species (oral route, rabbit) according to OECD guideline 414 will be considered. Since the results of the oral repeated dose toxicity studies and of the prenatal developmental toxicity study or any additional information relevant for the hazard assessment of Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts (CAS number: 61791-42-2) are not yet available, no changes regarding the endpoints repeated dose toxicity and toxicity to reproduction and developmental toxicity / teratogenicity are made. Based on the newly generated data, the hazard assessment with respect to toxicity after long-term exposure will be updated in due course.

Workers - Hazard via inhalation route

No route-specific acute and/or repeated inhalation toxicity studies are available for Sodium methyl cocoyl taurate and/or for the read-across substance Sodium methyl oleyl taurate. Route-to-route extrapolation is performed using the NOAEL of 1000 mg/kg bw/day from a 28-day oral toxicity study performed with the read-across substance Sodium methyl oleyl taurate, which was identified as key study for repeated dose toxicity. This NOAEL is used as starting point for the derivation of the worker DNEL "long-term inhalation exposure - systemic effects".

The corrected inhalatory NOAEC is obtained according to ECHA Guidance R.8 (ECHA, 2012) as 1763.16 mg/m³ (1000 mg/kg bw/day * (1/0.38 m³/kg bw/day) * (1/1) * 6.7 m³/ 10 m³). The assessment factors were chosen as described in ECHA Guidance R.8. Despite no systemic toxic relevant effects were noted and thus the point of departure (POD) used can be considered to be conservative, an assessment factor of 1 for dose-response is chosen. Since the assessment is based on the outcome of a 28 -day repeated dose toxicity study, time extrapolation to chronic exposure conditions generally have to be considered and the default factor of 6 (sub-acute to chronic) is used. With regard to interspecies differences, allometric scaling concerning oral-to-inhalation extrapolation is not appropriate and no assessment factor is applied. A factor of 1 for remaining interspecies differences is also supported, because toxicokinetic is considered to not differ between species. With regard to intraspecies variations, a default assessment factor of 5 was used to accommodate the variability in the human population. Since the available data on repeated dose toxicity are considered reliable and adequate, the quality of the data base is judged sufficient for evaluation and thus, an assessment factor of 1 is applied. Both, the target substance Sodium methyl cocoyl taurate and the read-across substance Sodium methyl oleyl taurate are chemically reaction products of fatty acid chlorides with sodium N-methyl taurinate and as such a close structural relationship exists. The only difference between both substances is seen in the origin of the fatty acid, which represents a C12-18-(even numbered, C18 unsaturated)-alkyl chain in the target molecule and a C18-(unsaturated)-alkyl chain in the source molecule.

The resulting overall assessment factor is 30 (6 x 5) resulting in a DNEL "long term inhalation exposure - systemic effects" of 58.77 mg/m³.

Workers - Hazard via dermal route

No route-specific repeated dermal toxicity data is available for Sodium methyl cocoyl taurate and/or the read-across substance Sodim methyl oleyl taurate. As default, route-to-route extrapolation is performed using the NOAEL of 1000 mg/kg bw/day from a 28-day oral toxicity study performed with the read-across substance Sodium methyl oleyl taurate, which was identified as key study for repeated dose toxicity. This NOAEL is used as starting point for the derivation of the worker DNEL "long term dermal exposure - systemic effects". The assessment factors were chosen based on the ECHA Guidance R.8 (ECHA, 2012). Despite no systemic toxic adverse effects were noted and thus the POD used can be considered to be conservative, assessment factors of 1 for dose-response and quality of data base seem to be appropriate. Since the assessment is based on the outcome of a 28-day repeated dose toxicity study, time extrapolation to chronic exposure conditions generally have to be considered and the default factor of 6 (sub-acute to chronic) is used. With regard to interspecies differences and to correct for differences in metabolic rate for the experimental animals, the default allometric scaling factor of 4 is chosen. A factor of 1 for remaining interspecies differences is also supported, because toxicokinetic is considered to not differ between species. With regard to intraspecies variations, a default assessment factor of 5 was used to accommodate the variability in the human population. The resulting overall assessment factor is 120 (6 x 4 x 5) leading to a DNEL "long-term dermal exposure - systemic effects" of 8.33 mg/kg body weight per day.

Additional information

No DNELs are derived for systemic toxicity and for local effects following acute exposure. It is 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 characterisation are not required under REACh. These uses are under the scope of Regulation (EC) No 1223/2009 on cosmetic products.