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EC number: 500-465-4 | CAS number: 160901-28-0 1 - 2.5 moles ethoxylated
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
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- Auto flammability
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- Additional physico-chemical properties of nanomaterials
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- Endpoint summary
- Stability
- Biodegradation
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- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
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- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Endpoint summary
Administrative data
Description of key information
skin sensitization (OECD 406): not sensitizing
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1992)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Test was done before LLNA as first-choice method for in-vivo testing was set into force.
- Species:
- guinea pig
- Strain:
- other: Crl: HA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: Approximately 6 weeks old
- Weight at study initiation: 396 - 492 g
- Housing: In groups
- Diet ad libitum: Altromin 3122 maintenance diet for guinea pigs
- Water ad libitum: tap water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: vaseline
- Concentration / amount:
- intradermal induction: 2.5%
epicutaneous induction: 1.5% - No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- epicutaneous challenge: 0.5%
- No. of animals per dose:
- test group 10 animals; negative and positive control group 5 animals each
- Details on study design:
- RANGE FINDING TESTS:
A range finding test was performed with 10 animals. The concentrations used in the main experiment based on the results of this test.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: a 2.5% concentration of the test item in physiological saline 0.9% NaCl
Injection 3: a 2.5% concentration of the test item formulated in a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Epicutaneous: 1.5% in vaseline
- Negative control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: 100% physiological saline 0.9% NaCl
Injection 3: a 50% (v/v) formulation of physiological saline 0.9% NaCl in a 1:1 (v/v) mixture FCA/physiological saline 0.9% NaCl
Epicutaneous: pure vaseline
- Positive control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: 2% mercaptobenzothiazole in cottonseed oil
Injection 3: a 50% (v/v) formulation of 2% mercaptobenzothiazole in a 1:1 (v/v) mixture FCA/physiological saline 0.9% NaCl
Epicutaneous: 25% mercaptobenzothiazole
- Site: shoulder (intradermal + epicutaneous)
- Frequency of applications: Intradermal Day 0, epicutaneous Day 7
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: day 20
- Exposure period: 24 hours
- Test groups: 0.5% of test item in vaseline
- Negative control group: vaseline
- Positive control group: 15% mercaptobenzothiazole
- Site: flank
- Evaluation (hr after challenge): 24 and 48 h after removal of challenge patch. - Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole
- Positive control results:
- The positive control substance induced positive reactions in 5/5 animals (100%).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 2%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 2%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- disregarded due to major methodological deficiencies
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- other: Methodological deficiencies.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- GPMT
- Deviations:
- yes
- Remarks:
- no positive or negative controls
- GLP compliance:
- no
- Remarks:
- Study was conducted prior to implementation of GLP.
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- male
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Intradermal induction: 5%
Epicutaneous induction: undiluted test material and pretreatment with SDS - No.:
- #1
- Route:
- other: epicutaneous; no additional data
- Vehicle:
- water
- Concentration / amount:
- Challenge: undiluted test material
- No. of animals per dose:
- 10
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- neat material
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- neat material
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Refer to the Category Approach Justification document provided in IUCLID6 Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Species:
- guinea pig
- Strain:
- other: Crl: HA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: Approximately 6 weeks old
- Weight at study initiation: 396 - 492 g
- Housing: In groups
- Diet ad libitum: Altromin 3122 maintenance diet for guinea pigs
- Water ad libitum: tap water
- Acclimation period: at least five days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: vaseline
- Concentration / amount:
- intradermal induction: 2.5%
epicutaneous induction: 1.5% - No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- epicutaneous challenge: 0.5%
- No. of animals per dose:
- test group 10 animals; negative and positive control group 5 animals each
- Details on study design:
- RANGE FINDING TESTS:
A range finding test was performed with 10 animals. The concentrations used in the main experiment based on the results of this test.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: a 2.5% concentration of the test item in physiological saline 0.9% NaCl
Injection 3: a 2.5% concentration of the test item formulated in a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Epicutaneous: 1.5% in vaseline
- Negative control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: 100% physiological saline 0.9% NaCl
Injection 3: a 50% (v/v) formulation of physiological saline 0.9% NaCl in a 1:1 (v/v) mixture FCA/physiological saline 0.9% NaCl
Epicutaneous: pure vaseline
- Positive control group:
Intradermal (3 pairs of injections):
Injection 1: a 1:1 mixture (v/v) FCA/physiological saline 0.9% NaCl
Injection 2: 2% mercaptobenzothiazole in cottonseed oil
Injection 3: a 50% (v/v) formulation of 2% mercaptobenzothiazole in a 1:1 (v/v) mixture FCA/physiological saline 0.9% NaCl
Epicutaneous: 25% mercaptobenzothiazole
- Site: shoulder (intradermal + epicutaneous)
- Frequency of applications: Intradermal Day 0, epicutaneous Day 7
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: day 20
- Exposure period: 24 hours
- Test groups: 0.5% of test item in vaseline
- Negative control group: vaseline
- Positive control group: 15% mercaptobenzothiazole
- Site: flank
- Evaluation (hr after challenge): 24 and 48 h after removal of challenge patch. - Positive control substance(s):
- yes
- Remarks:
- mercaptobenzothiazole
- Positive control results:
- The positive control substance induced positive reactions in 5/5 animals (100%).
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 2%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2.5%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 2%
- No. with + reactions:
- 5
- Total no. in group:
- 5
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- CLP: not classified
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No reliable data on sensitisation are available for AES (C9-11, 1-2.5 EO) Na (CAS 160901-28-0). Therefore this endpoint is covered by read-across to structurally related AES, i.e. AES (C8-10, 1-2.5 EO) Na. The AES reported within the category show similar structural, physico-chemical, environmental and toxicological properties. The approach of grouping different AES for the evaluation of their effects on human health and the environment was also made by the Danish EPA (2001) and HERA (2003), supporting the read-across approach between structurally related AES.
There is one study available addressing the skin sensitising properties of AES (C8-10, 1-2.5 EO) Na.
The skin sensitizing potential was assessed in a Guinea Pig Maximisation Test according to OECD Guideline 406 (Z&S, 2013). In this study 10 female guinea pigs were induced by intradermal and epicutaneous application of the test item at concentrations of 2.5% (intradermal induction) and 1.5% (epicutaneous induction). Challenge was performed with 0.5% test item. Vaseline was used as vehicle. The concentrations were chosen on basis of a preliminary range finding test. In the positive control group 5 of 5 animals (100%) showed a positive response at the 24 and 48 h reading. No positive response was observed in animals of the negative control and test item group at any observation time. Thus, the test item showed no sensitising potential within this study.
This lack of sensitising properties of AES is also supported by the evaluation of various AES reported in the HERA report (2003).
References:
Danish EPA - Environmental and Health Assessment of Substances in Household Detergents and Cosmetic Detergent Products (2001). Environmental Project No. 615, pp. 24-28
HERA (2003). Human & Environmental Risk Assessment on ingredients of European household cleaning products Alcohol Ethoxysulphates, Human Health Risk Assessment Draft, 2003. http: //www. heraproject. com.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.
Justification for classification or non-classification
The available data on skin sensitisation do not meet the criteria for classification according to Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.
No data available for respiratory sensitisation.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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