Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.225 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):
36
Modified dose descriptor starting point:
NOAEC
Explanation for the modification of the dose descriptor starting point:
No data for submission substance following inhalation exposure available
AF for dose response relationship:
1
Justification:
ECHA Guidance (reliable dose-response, POD is NOAEL)
AF for differences in duration of exposure:
6
Justification:
ECHA Guidance (extrapolation from subacute to chronic exposure)
AF for interspecies differences (allometric scaling):
1
Justification:
ECHA Guidance (inhalation route)
AF for other interspecies differences:
1
Justification:
ECHA Guidance (inhalation route)
AF for intraspecies differences:
3
Justification:
No differences in toxicity expected as test item consists of natural occuring constituents (amino acid and fatty acids)
AF for the quality of the whole database:
1
Justification:
Available data on systemic toxicity comparable and plausible.
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:
medium 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:
34.725 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):
72
Modified dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:
No data for submission substance following dermal exposure route available.
AF for dose response relationship:
1
Justification:
ECHA Guidance (reliable dose-response, POD is NOAEL)
AF for differences in duration of exposure:
6
Justification:
ECHA Guidance (subacute to chronic extrapolation)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA Guidance (rat to humans)
AF for other interspecies differences:
1
Justification:
Modified according to German Committee of Hazardous Substances (AGS) and ECETOC, no differences in toxicokinetics between species expected
AF for intraspecies differences:
3
Justification:
Modified according to German Committee of Hazardous Substances (AGS) and ECETOC, no differences in toxicokinetics between species expected
AF for the quality of the whole database:
1
Justification:
Available data considered sufficient for extrapolation purposes.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties expected as the test item consists of natural occuring constituents (amino acid and fatty acids) .
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)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

No studies on the EC substance [940-223-9] itself are available. A read-across approach using the very close structural analogue [938-147-6] Fatty acid chlorides, C8-14 (even numbered), reaction products with glycine (Public name: Sodium cocoyl glycinate (SCG)) as source substance was chosen. A respective justification of the read-across approach is provided separately under IUCLID chapter 13 (Assessment reports).

Taking the available data base of the source molecule, the NOAEL of 1000 mg/kg body weight per day is considered the most relevant starting point for the risk characterization of workers in occupational settings. However, to cover all eventualities, a more prudent approach by using the conservative NOAEL of 250 mg/kg body weight per day from the reproductive toxicity screening study is taken for respective DNEL derivations.

For the appropriateness of the assessment factors used for the derivation of DNELs regarding workers, the following aspects were considered and, when appropriate, adjustments were made to account for uncertainty and variablity:

- overall confidence in the data base:

The available data have been evaluated with regard to their reliability, relevance and completeness. Based hereupon no indications exist to assume limited reliability and/or relevance of the data base used.

- intra- and interspecies variation:

Corrections -when appropriate- have been made for potential intra- and interspecies differences between laboratory animals and humans using allometric scaling (4 for rats) and appropriate additional assessment factors.

- nature and severity of effects:

The observed effects in animals are primarily driven by the irritative nature, are considered portal of entry or `first site contact` effects, or can be attributed to other factors like the high sodium chloride content in the registered substance.

- dose-response relationship:

There is no reason to assume special concern. Up to the limit dose for evaluation systemic toxicity (1000 mg/kg body weight per day) no effects which are considered of biological relevance have occurred. Statistical significant and/or 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):

Route-to-route extrapolation using the NOAEL from repeated oral exposure data was carried out for assessing the dermal and inhalation route of exposure. Corrections for exposure duration have been considered by applying appropriate assessment factors. With regard to the oral-to-inhalation extrapolation, an additional default factor of 2 was included to account for worst case maximum absorption.

- other factors:

There are no other factors known that might require a particular margin of safety.

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The registered substance is exclusively used as cosmetic ingredient and consumer aspects are thus covered under separate guidelines.