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EC number: 946-061-5 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
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- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- 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
- Terrestrial toxicity
- 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
No significant concern can be reliably derived for the registration substance with respect to the endpoint sensitisation.
Guinea pig maximisation test (study performed prior to adoption of LLNA guideline): Not sensitising (according to OECD guideline 406 / EU method B.6), Induction: intradermal with 0.5% test substance concentration, epidermal with 10% test substance concentration on day 7; Challenge: topical with 1% (highest non-irritating concentration) and 0.3% test substance concentration; no signs of erythema or oedema in any reading. Read-across:Polyoxyethylene(9) oleyl ether carboxylic acid
Guinea pig maximisation test (study performed prior to adoption of LLNA guideline): Not sensitising (according to OECD guideline 406 / EU method B.6), Induction: intradermal with 0.5% test substance concentration, epidermal with undiluted test substance concentration on day 7; Challenge: topical with 0.01% test substance concentration (highest non-irritating concentration); no signs of erythema or oedema in any reading. Read-across:Polyoxyethylene(4.5) lauryl miristyl ether carboxylic acid
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- REPORTING FORMAT FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar toxicological properties because
• they are manufactured from similar / identical precursors under similar conditions
• they share structural similarities with common functional groups:
o fatty alcohol ethoxylates with a terminating carboxylic acid group
o a linear alkyl moiety (differing slightly in length and degree of saturation)
o ethylene oxide chain (varying slightly in mean length)
Therefore, read-across from the existing sensitisation studies on the source substances is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation. - Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.01%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin reactions were evident in the control animals and animals of the test group
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- for Polyoxyethylene(4.5) lauryl miristyl ether carboxylic acid
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.01%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin reactions were evident in the control animals and animals of the test group
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- for Polyoxyethylene(4.5) lauryl miristyl ether carboxylic acid
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0,3% and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin reactions were evident in the control animals and animals of the test group
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- for Polyoxyethylene(9) oleyl ether carboxylic acid
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.3% and 1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no skin reactions were evident in the control animals and animals of the test group
- Remarks on result:
- no indication of skin sensitisation
- Remarks:
- for Polyoxyethylene(9) oleyl ether carboxylic acid
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the available data Polyoxyethylene(1 to 2.5) oleyl ether carboxylic acid is not be classified as sensitising to the skin according to regulation (EC) 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Data on sensitisation are not available for the target substance Polyoxyethylene(1 to 2.5) oleyl ether carboxylic acid. For the assessment of the skin sensitisation potential of Polyoxyethylene(1 to 2.5) oleyl ether carboxylic acid, results from the following studies are taken into consideration:
- an GMPT according to OECD guideline 406 with the source substance Polyoxyethylene(9) oleyl ether carboxylic acid
- an GPMT according to OECD guideline 406 with the source substance Polyoxyethylene(4.5) lauryl miristyl ether carboxylic acid
In a dermal sensitisation study according to OECD Guideline 406 (adopted 17th July 1992) with Polyoxyethylene(9) oleyl ether carboxylic acid (90% a.i.) in distilled water, young adult female Albino Hartley guinea pigs (10 in test group, 5 in control group) were tested using the method of Magnusson and Kligman. DNCB (2,4-dinitrochlorobenzene) and formaldehyde were used as historical positive control substances.
Based on the results of a preliminary study, the test substance concentrations selected for the main study were a 0.5% concentration (in 0.9% NaCl solution) for the intradermal induction and a 10% concentration (in distilled water) for the epidermal induction exposure. A 1 and 0.3% test substance concentration (in distilled water) was selected for the challenge phase.
Following a challenge exposure to a 1 and 0.3% test substance concentration, no skin reactions were evident in the control animals and all other experimental animals (24 and 48h readings). The sensitisation rate was 0%.
According to CLP, EU GHS (Regulation (EC) No 1272/2008), a response of at least 30% of the test animals of an adjuvant type guinea pig test method for skin sensitisation is considered as positive.
Polyoxyethylene(9) oleyl ether carboxylic acid is not a dermal sensitiser in this study.
In a dermal sensitisation study according to OECD Guideline 406 (adopted 17th July 1992) and EU method B.6 (1992) with Polyoxyethylene(4.5) lauryl miristyl ether carboxylic acid (90% a.i.) in hydroxypropyl-methylcellulose gel, young adult male Dunkin-Hartley guinea pigs (10 in test group, 5 in control group) were tested using the method of Magnusson and Kligman. Potassium dichromate was used as positive control.
Based on the results of a preliminary study, the test substance concentrations selected for the main study were a 0.5% concentration (in 0.9% NaCl solution) for the intradermal induction and a 100% concentration for the epidermal induction exposure. A 0.01% test substance concentration (in 0.8% aqueous hydroxypropyl-methylcellulose gel) was selected for the challenge phase.
After epidermal induction all animals of the experimental group showed signs of irritation. Following a challenge exposure to a 0.01% test substance concentration, no skin reactions were evident in the control animals and animals of the test group (24, 48 and 72 h readings). The sensitisation rate was 0%.
According to CLP, EU GHS (Regulation (EC) No 1272/2008), a response of at least 30% of the test animals of an adjuvant type guinea pig test method for skin sensitisation is considered as positive.
Polyoxyethylene(4.5) lauryl miristyl ether carboxylic acid is not a dermal sensitiser in this study.
Justification for read-across
Hypothesis for the analogue approach
This read-across is based on the hypothesis that source and target substances have similar toxicological properties because
· they are manufactured from similar / identical precursors under similar conditions
· they share structuralsimilarities with common functional groups:
o fatty alcohol ethoxylates with a terminating carboxylic acid group
o a linear alkyl moiety (differing slightly in length and degree of saturation)
o ethylene oxidechain (varying slightly in mean length)
Therefore, read-across from the existing sensitisation studies on the source substances is considered as an appropriate adaptation to the standard information requirements of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.
The justification of the proposed read-across approach is elaborated in the next chapters.
1. Substance Identities
The target and source substances are manufactured by the reaction of fatty alcohol ethoxylates with sodium chloroacetate under alkaline conditions. The main components can be described as fatty alcohol ethoxylate linked via ether bond to the acetic acid. The general structure of the alkyl polyglycol ether carboxylic acidis:
R-O-(CH2CH2O-)nCH2COOH
with R = linear alkyl chain, C12 – C18, C18:1
and n = 1 - 9
The target substance Polyoxyethylene(1 to 2.5) oleyl ether carboxylic acid contains mainly 9-octadecenyl chains (=C18 unsaturated) and a mean number of 2.5 EO units.
The source substances vary in thecarbon chain length of the alkyl chain as well as in the number of EO units:
The source substance Polyoxyethylene(9) oleyl ether carboxylic acid contains a 9-octadecenyl chain (=C18 unsaturated) and a mean number of 9 EO units.
The source substance Polyoxyethylene(4.5) lauryl miristyl ether carboxylic acid contains lauryl and myristyl chains (C12, C14, saturated) and a mean number of 4.5 EO units.
Table 1: Substance identities
Target substance
Source substances
Polyoxyethylene(1 to 2.5) oleyl ether carboxylic acid
Polyoxyethylene(9) oleyl ether carboxylic acid
Polyoxyethylene(4.5) lauryl miristyl ether carboxylic acid
CAS number
57635-48-0
57635-48-0
27306-90-7
Moles EO (mean)
2.5
9
4.5
Chain length distribution
C12: < 5%
C14: < 10%
C16: 2 - 25%
C18 1 - 15 %
C18:1(oleyl):60- 95%
C12: < 5%
C14: < 10%
C16: 2 - 25%
C18 1 - 15 %
C18:1(oleyl):60- 95%
C12: 70%
C14: 30%
Composition
Alkylethercarboxylic acid: 60-90%
Alkylethoxylate < 2.5 EO: 5-30%
Ester: 0-25%
n.a.
Fatty alcohol: 8%
Minor constituents
Alkylethercarboxylic acid: 30-80%
Alkylethoxylate <2.5EO: 5-40%
Esterification products ofAlkylethercarboxylic acidand Alkylethoxylate: 1-35%
Fatty alcohol: < 1%
Alkylethercarboxylic acid: 30-80%
Alkylethoxylate:0-40%
Esterification products of Alkylethercarboxylic acid and Alkylethoxylate: 1-35%
Fatty alcohol: < 1%
Alkylethercarboxylic acid: 30-80%
Alkylethoxylate: 0-40%
Esterification products of Alkylethercarboxylic acid and Alkylethoxylate: 1-35%
Fatty alcohol: < 10 %
2. Impurities
The target and source substances belong to the group of alkyl polyglycol ether carboxylic acid, which are manufactured from different fatty alcohol ethoxylates as raw material. Since the impurities in the fatty alcohol ethoxylates are considered to be comparable, the impurities of the registration substance and of other alkyl polyglycol ether carboxylic acid are expected to be comparable. A difference in irritation or sensitisation potential due to different impurity profiles is not likely.
3. Analogue approach justification
The read-across hypothesis is based on structural similarity of target and source substances. The respective reliable data (RL 1 or 2) are summarized in the data matrix; robust study summaries are included in the Technical Dossier in the respective sections.
The read-across from the source substances is justified:
a) Based on the information given in section 1, it can be concluded that the substances are similar in structure, since they are manufactured from similar or identical precursors under similar conditions and all contain the same functional groups. Thus a common mode of action can be assumed.
b) The content of minor constituents in all products are comparable and differ to an irrelevant amount.
c) The only deviations within this group of substances is a variety in their alkyl chain length as well as in the number of EO units, which is not expected to have a relevant impact on intrinsic toxic activity.
3.1. Structural similarity and functional groups (Table 1)
The general structure of the alkyl polyglycol ether carboxylic acidis:
R-O-(CH2CH2O-)nCH2COOH
with R = linear alkyl chain, C12 – C18, C18:1
and n = 1 - 9
target substance:
Polyoxyethylene(2.5) oleyl ether carboxylic acid: R = C18:1, n =2.5.
source substances:
Polyoxyethylene(9) oleyl ether carboxylic acid: R = C18:1, n =9
Polyoxyethylene(4.5) lauryl miristyl ether carboxylic acid: R = C12-14, n =4.5
3.2. Differences
Differences in chemical and other intrinsic properties of the target and source substances potentially arise from the following facts:
- Differences in C-chain length and unsaturated moieties:
The source substance Polyoxyethylene(4.5) lauryl miristyl ether carboxylic acid contains mainly shorter chain lengths (C12 - 14, saturated) compared to the target substance (mainly C18:1).
The presence of unsaturated C18 chains may be considered as a worst case with respect with respect to local effects (irritation, sensitisation) (HERA, 2002; Stillman, 1975; Aungst, 1989). As also data on skin irritation and sensitisation are available for the source substance Polyoxyethylene(9) oleyl ether carboxylic acid (containing C18:1 chains like the target substance), it is demonstrated based on experimental data, that the small difference in C-chain length and degree of unsaturation is not relevant for this read-across approach.
- Differences in number of EO units:
The degree of ethoxylation may influence the irritation potential: longer EO chains may exhibit a slightly lower irritation potential (HERA, 2009). However, the difference in number of EO units is rather small between the target and source substances (ranging from 2.5 to 9). Ethoxylation is generally not associated with sensitisation (HERA, 2009). Thus, difference in the number of EO units is of no concern for this endpoint.
The target and source substances belong to the group of alkyl polyglycol ether carboxylic acid, the structural difference being only different alkyl moieties and number of ethylene glycol units. Based on the incremental change in the chemical structures among the members, the read-across is justified with high confidence.
4. Data matrix
Polyoxyethylene(2.5) oleyl ether carboxylic acid
Source chemicals: Alkyl polyglycol ether carboxylic acid
Endpoints
Hazard profile/ Hazard assessment method
Hazard profile
Irritation
Skin
read-across
Not irritating
C12-14/4.5EO/27306-90-7
C12-14/2.5EO/NA Salt/33939-64-9
Oleyl/9EO/57635-48-0
C12-14/4.5EO Na Salt/33939-64-9
Eye
read-across
corrosive
C12-14/4.5EO/27306-90-7
Skin Sensitization
read-across
not sensitizing
Oleyl/9EO/57635-48-0
C12-14/4.5EO/27306-90-7
Schematic overview sensitisation
Target substance
Polyoxyethylene(9) oleyl ether carboxylic acid
Polyoxyethylene(1 to 2.5) oleyl ether carboxylic acid
Polyoxyethylene(4.5) lauryl miristyl ether carboxylic acid
Moles EO (mean)
9
2.5
4.5
Main alkyl chain
C18:1
C18:1
C12 / C14
Na salt / free acid
Acid
Acid
Acid
Based on interpolation from the results obtained with the source substances Polyoxyethylene(9) oleyl ether carboxylic acid and Polyoxyethylene(4.5) lauryl miristyl ether carboxylic acid, which were both not sensitizing, the target substance Polyoxyethylene(1 to 2.5) oleyl ether carboxylic acid is considered to be not sensitizing.
5. Quality of the experimental data of the analogues
The available data are adequate and sufficiently reliable to justify the read-across approach.
The studies were conducted according to OECD Guideline 406 (GPMT) and are reliable without restrictions (RL1).
The test materials used in the respective studies represent the source substance as described in the hypothesis in terms of substance identity and minor constituents.
Overall, the study results are adequate for the purpose of classification and labelling and risk assessment
6. References
Aungst, 1989. Structure/Effect Studies of Fatty Acid Isomers as Skin Penetration Enhancers and Skin Irritants. Pharmaceutical Research, March 1989, Volume 6, Issue 3, pp 244-247
HERA, 2002: Fatty Acid Salts – Human Health Risk Assessment; http://www.heraproject.com/files/5-HH-04-HERA%20Fatty%20acid%20salts%20HH%20web%20wd.pdf
HERA, 2009: Alcohol Ethoxylates; http://www.heraproject.com/files/34-F-09%20HERA%20AE%20Report%20Version%202%20-%203%20Sept%2009.pdf
Stillman et al., 1975. Relative irritancy of free fatty acids of different chain length. Contact Dermatitis. 1975;1(2):65-9.
Conclusion skin sensitisation
There is no data gap for skin sensitisation. Although no human data are available for Polyoxyethylene(1 to 2.5) oleyl ether carboxylic acid, there is no reason to believe that results obtained in guinea pigs would not be applicable to humans.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
There is no information available for respiratory sensitisation. Therefore, there is a data gap in this respect. However, the data gap cannot be fulfilled with experimental data, since there is no internationally accepted animal model for respiratory sensitisation. In case human data for respiratory sensitisation emerges, this will be taken into account.
Justification for classification or non-classification
Based on relevant, reliable and adequate data, Polyoxyethylene(1 to 2.5) oleyl ether carboxylic aciddoes not have to be classified and labelled according to the CLP Regulation (EC) No 1272/2008 with respect to skin 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.
