Registration Dossier
Registration Dossier
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EC number: 616-248-3 | CAS number: 75627-31-5
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Endpoint conclusion:
- no study available
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
There is no specific test data available on potential reproductive toxic effect of Nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5). However, in accordance with Annex XI(3) of the REACH regulation, such study are not required, based on no significant exposure. Exposure based modeling of the all the contributing scenarios in the manufacturing process, using the ECETOC TRA or the Advanced REACH Tool (ART) models, shows air levels that are well below the derived DNEL. There is no exposure to general population, since there is no consumer use and there is no release to the environment via water, air nor soil as all waste streams are incinerated, vapours from reaction vessels are condensed and all industrial surfaces are hardened and run-off is lead to waste. It is not considered justified on animal welfare grounds to perform additional animal toxicity studies with this substance. Waiving of this study will ensure that further animal testing is avoided.
Short description of key information:
There is no test data available on potential reproductive toxic effect of nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5). Based on no significant exposure, only industrial handling during manufacturing and no consumer use, it is not considered justified on animal welfare grounds to perform additional animal toxicity studies with this substance.
Justification for selection of Effect on fertility via oral route:
There is no specific test data available on potential reproductive toxic effect of Nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5). However, in accordance with Annex XI(3) of the REACH regulation, such study are not required, based on no significant exposure. Exposure based modeling of the all the contributing scenarios in the manufacturing process, using the ECETOC TRA or the Advanced REACH Tool (ART) models, shows air levels that are well below the derived DNEL. There is no exposure to general population, since there is no consumer use and there is no release to the environment via water, air nor soil as all waste streams are incinerated, vapours from reaction vessels are condensed and all industrial surfaces are hardened and run-off is lead to waste. It is not considered justified on animal welfare grounds to perform additional animal toxicity studies with this substance. Waiving of this study will ensure that further animal testing is avoided.
Justification for selection of Effect on fertility via inhalation route:
Inhalation is not expected to be a significant route of exposure since nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5) is produced within a ventilated factory with risk management measures in place to limit the exposure. Therefore it is not considered to be scientifically valid to conduct an inhalation study.
Justification for selection of Effect on fertility via dermal route:
Based on the physicochemical properties of nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5), it is considered very unlikely that dermal absorption would exceed oral absorption, so it is not considered relevant to conduct a dermal study
Effects on developmental toxicity
Description of key information
There is no specific test data available on potential reproductive toxic effect of nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5). The exposure from manufacturing is considered to be not significant. Exposure based modeling of the all the contributing scenarios in the manufacturing process, using the ECETOC TRA or the Advanced REACH Tool (ART) models, shows air levels that are well below the derived DNEL. There is no exposure to general population, since there is no consumer use and there is no release to the environment via water, air nor soil as all waste streams are incinerated, vapours from reaction vessels are condensed and all industrial surfaces are hardened and run-off is lead to waste.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via inhalation route
- Endpoint conclusion:
- no study available
Effect on developmental toxicity: via dermal route
- Endpoint conclusion:
- no study available
Additional information
Nonylphenol ethoxylate, sarcosine derivative (CAS No 75627-31-5), is manufactured in volumes between 100 - 1000 tonnes per year, butis only manufactured in closed chemical processes with no significant exposure and there are no registered uses within European Union as the total volume is exported from Europe.
The exposure from manufacturing is considered to be not significant. Exposure based modeling of the all the contributing scenarios in the manufacturing process, using the ECETOC TRA or theAdvanced REACH Tool (ART) models, shows air levels that are wellbelow the derived DNEL.There is no exposure to general population, since there is no consumer use and there is no release to the environment via water, air nor soil as all waste streams are incinerated, vapours from reaction vessels are condensed and all industrial surfaces are hardened and run-off is lead to waste.
Annex XI(3) of the REACH regulation describes substance-tailored exposure-driven testing which is considered applicable for this case, as the exposure is not significant, a DNEL value is available and the comparison between the derived DNEL and the exposure assessment shows that exposures are well below the DNEL.
The available OECD 407, 28 Day oral study in rats indicates a limited toxicity profile of the substance with a NOAEL of 1000 mg/kg bw. This study allows the determination of DNEL values for oral, inhalation and dermal exposure following the ECHA guidance document for deriving DNEL values. It is not considered justified on animal welfare grounds to perform additional animal toxicity studies with this substance. Waiving of this study will ensure that further animal testing is avoided.
Justification for selection of Effect on developmental toxicity: via oral route:
There is no specific test data available on potential developmental toxic effect of Nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5). However, in accordance with Annex XI(3) of the REACH regulation, such study are not required, based on no significant exposure. Exposure based modeling of the all the contributing scenarios in the manufacturing process, using the ECETOC TRA or the Advanced REACH Tool (ART) models, shows air levels that are well below the derived DNEL. There is no exposure to general population, since there is no consumer use and there is no release to the environment via water, air nor soil as all waste streams are incinerated, vapours from reaction vessels are condensed and all industrial surfaces are hardened and run-off is lead to waste. It is not considered justified on animal welfare grounds to perform additional animal toxicity studies with this substance. Waiving of this study will ensure that further animal testing is avoided.
Justification for selection of Effect on developmental toxicity: via inhalation route:
Inhalation is not expected to be a significant route of exposure since nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5) is produced within a ventilated factory with risk management measures in place to limit the exposure. Therefore it is not considered to be scientifically valid to conduct an inhalation study.
Justification for selection of Effect on developmental toxicity: via dermal route:
Based on the physicochemical properties of nonylphenol ethoxylate, sarcosine derivative (CAS no 75627-31-5), it is considered very unlikely that dermal absorption would exceed oral absorption, so it is not considered relevant to conduct a dermal study.
Justification for classification or non-classification
Additional information
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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