Registration Dossier
Registration Dossier
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EC number: 269-087-2 | CAS number: 68187-32-6
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.321 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 37.5
- Modified dose descriptor starting point:
- other: LOEL
- Value:
- 12.042 mg/m³
- AF for other interspecies differences:
- 2.5
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.282 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 37.5
- Modified dose descriptor starting point:
- other: LOEL
- Value:
- 10.564 mg/kg bw/day
- AF for other interspecies differences:
- 2.5
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- repeated dose toxicity
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - workers
Toxic kinetics:
Adsorption:
The absorption capacity of Sodium Cocoyl glutamate is low (as has been stated section 5.4.1 of the dossier), which is also supported by the fact that the bioaccumulation factor for the substance is much lower and so even after the exposure the absorption capability will be less in this case.
Distribution:
In case the substance, Sodium Cocoyl glutamate, is absorbed (though in small quantity) it will not be accumulated in the body. This is supported by the fact that the substance have not only low BCF value (as mentioned in section 5.3.1 of the same dossier) but also have a moderate level of Kow which will support the reasoning that though the substance will enter the body but will get distributed through the lipid in the body.
Excretion:
Further to this distribution after the absorption process, the excretion process through urine would be faster as the molecular weight of the substance, Sodium Cocoyl glutamate, is > 300 and this is a favourable value for excretion via the urine route.
Skin & eye irritation:
From the available data and using the weight of evidence approach by considering the information for other sources as well as read-across, it can be concluded that the chemical Sodium Cocoyl glutamate is unlikely to be irritating to the skin and eyes of humans.
Skin sensitizer:
According to the quantitative structure activity relationship model prediction, l-Glutamic acid, N-coco acyl derivs., monosodium salts was predicted as not sensitizing to Guinea Pig skin. The study report as well indicates non sensitizing effect and so considering the weight of evidences of the study report and estimation it can be concluded that the substance is non sensitizing to skin.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.08 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- other: LOEL
- Value:
- 5.991 mg/m³
- AF for other interspecies differences:
- 2.5
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.069 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- other: LOEL
- Value:
- 5.21 mg/kg bw/day
- AF for other interspecies differences:
- 2.5
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- repeated dose toxicity
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- repeated dose toxicity
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.563 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 75
- Modified dose descriptor starting point:
- other: LOEL
- Value:
- 21.127 mg/kg bw/day
- AF for other interspecies differences:
- 2.5
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - General Population
DNEL derivation
From the available data, it can be seen that the chemical Sodium Cocoyl glutamate is not likely to exhibit acute toxicity by the oral, dermal or inhalation route.From the available data and using the weight of evidence approach by considering the information for other sources as well as read-across, it can be concluded that the chemical Sodium Cocoyl glutamate is unlikely to be irritating to the skin and eyes of rabbit. Moreover the studies also indicate that the chemical does not exhibit genotoxicity and is not a reproductive and developmental toxin within the dose levels mentioned in the end points
In the absence of local effects following short-term or long-term exposure, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for local exposure are therefore not calculated.
In the absence of acute systemic toxicity, no dose-response data are available and a quantitative dose descriptor is not derived. DNEL values for acute systemic effects are therefore not calculated.
A standard approach to deriving DNEL values would be to use the repeated dose toxicity dataset and apply assessment factors as described in ECHA guidance documents. The critical endpoint is considered to be the LOEL of23.965mg/kg bw/d in inhalation category.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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