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EC number: 931-558-1 | CAS number: 90583-11-2
- 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
- Nanomaterial photocatalytic activity
- 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 data are available for the target substance sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, ammonium salts (CAS 90583-11-2). Therefore, read-across from structural analogue substances has been applied.
Skin sensitisation (OECD 406, GPMT): not sensitising
Read-across from source substance sulfuric acid, mono-C12-16-alkyl esters, potassium salts (CAS 90583-12-3), supported by additional studies with a structural analogue substances.
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)
- Remarks:
- Summary of available data used for the endpoint assessment of the target substance.
- 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
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Source, key, 90583-12-3, 1988
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Source, key, 90583-12-3, 1988
- Group:
- positive control
- Remarks on result:
- other: no information on positive control in study Source, key, 90583-12-3, 1988
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
- Conclusions:
- In a guinea pig maximisation test (GPMT), no skin sensitisation was observed following occlusive epicutaneous challenge after induction treatments (intracutaneous injection and occlusive epicutaneous exposure).
- Executive summary:
The skin sensitisation potential of the target substance is estimated based on an adequate and reliable in vivo study of a structural analogue source substance. In a guinea pig maximisation test (GPMT), no skin sensitisation was observed following occlusive epicutaneous challenge after induction treatments (intracutaneous injection and occlusive epicutaneous exposure). As explained in the category justification, the differences in molecular structure between the target and the source substances are unlikely to lead to differences in the skin sensitisation potential.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There are no data on skin sensitisation available for the target substance sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, ammonium salts (CAS 90583-11-2). Therefore, this endpoint is covered by read-across from structurally related alkyl sulfates (AS). The possibility of a read-across from other alkyl sulfates in accordance with Regulation (EC) No. 1907/2006, Annex XI 1.5 “Grouping of substances and read-across approach” was assessed. In Annex XI 1.5 it is given that a read-across approach is possible for substances whose physico-chemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity. The AS reported within the AS category show structural similarity. The most important common structural feature of the category members is the presence of a predominantly linear aliphatic hydrocarbon chain with a polar sulfate group, neutralised with a counter ion. This structural feature confers the surfactant properties of the alkyl sulfates. The surfactant property of the members of the AS category in turn represents the predominant attribute in mediating effects on mammalian health. Therefore, the members of the AS category have similar physico-chemical, environmental and toxicological properties, validating the read-across approach within the category. The approach of grouping different AS for the evaluation of their effects on human health and the environment was also made by the OECD in the SIDS initial assessment profile [1] and by a voluntary industry programme carrying out Human and Environmental Risk Assessments (HERA [2]), further supporting the read-across approach between structurally related AS.
Ammonium sulfate is used to produce AS NH4 within the current AS category. There is a substantial data base on ammonium sulfate online available. Ammonium sulfate is not listed in Annex VI of Regulation (EC) No. 1272/2008 (CLP). In addition, the effects of ammonium sulfate on human health were assessed by the OECD in the SIDS initial assessment report [3]. Ammonium sulfate gives no rise to concern of adverse effects on human health. Therefore, a contribution of ammonium sulfate to the effects on human health is considered to be negligible when assessing human health effects of the target substance sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, ammonium salts (CAS 90583-11-2).
Skin sensitisation
Due to the fact that no data for the target substance are available, the results of a key study performed with the structural analogue substance sulfuric acid, mono-C12-16-alkyl esters, potassium salts (CAS 90583-12-3) are used to assess this endpoint. In addition, data obtained with the analogue substances coconut oil, sulfated, ammonium salt (CAS 90989-98-3) and sulfuric acid, palm kernel-oil mono-ester, ammonium salts (CAS 223705-48-4) are used as supportive information.
In a guinea pig maximisation test according to OECD Guideline 406 (BASF, 1988b), which is considered as key study, 20 Pirbright-Hartley guinea pigs were intradermal and epicutaneous induced at 0.1 and 2.5%, respectively, with the test substance sulfuric acid, mono-C12-16-alkyl esters, potassium salts (CAS 90583-12-3, analytical purity 30%). Challenge was performed at a concentration of 1%. The challenge and induction concentrations were based on a preliminary range-finding study. No skin reactions were observed upon challenge. Thus, the test item showed no significant sensitising potential within this study.
The skin sensitizing potential of sulfuric acid, palm kernel-oil mono-ester, ammonium salts (CAS 223705-48-4) was assessed in a Buehler test similar to OECD Guideline 406 (Stepan, 1990). Only limited data on the test item is available. 10 guinea pigs were topically induced 9 times over a period of 3 weeks with 0.1 % test substance and challenged with 0.1% test substance 2 weeks thereafter. 48 h after the first challenge a second challenge was performed with 0.1 % test item. Skin reactions were scored 24 and 48 h after challenge. The challenge and induction concentration was based on a preliminary range-finding study. No skin reactions were observed upon challenge. Thus, the test item showed no significant sensitising potential within this study.
Another supporting study was performed as Buehler test similar to OECD Guideline 406 with coconut oil, sulfated, ammonium salt (CAS 90989-98-3) on 10 guinea pigs. Only limited data on the test item is available (Stepan, 1991). Guinea pigs were topically induced 9 times over a period of 3 weeks with 0.1 % test substance and challenged with 0.1% test substance 2 weeks thereafter. 48 h after the first challenge a second challenge was performed with 0.1 % test item. Skin reactions were scored 24 and 48 h after challenge. The challenge and induction concentration was based on a preliminary range-finding study. No skin reactions were observed upon challenge. Thus, the test item showed no significant sensitising potential within this study.
Results of the above mentioned studies show that all three substances used for read across showed no skin sensitising properties. In addition, the structural related substance sodium lauryl sulfate is also recommended as an agent to induce local irritation in an OECD method to assess skin sensitising properties of chemicals (OECD guideline 406, Guinea Pig Maximisation Test). Therefore, there is a lot of experience with sodium lauryl sulfate in sensitising studies and no evidence occurred that it shows sensitising properties. Thus, skin sensitisation by members of the alkyl sulfates is generally unlikely.
[1] SIDS initial assessment profile, (2007); http://www.aciscience.org/docs/Alkyl_Sulfates_Final_SIAP.pdf
[2] (HERA Draft report, 2002); http://www.heraproject.com/files/3-HH-04-%20HERA%20AS%20HH%20web%20wd.pdf
[3] http://webnet.oecd.org/HPV/UI/SIDS_Details.aspx?Key=2c80d506-86bf-4719-be9b-d922022506ec&idx=0
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available data on skin sensitisation obtainded with structurally analogue substances do not meet the criteria for classification according to the CLP Regulation (EC) No. 1272/2008 and are, therefore, conclusive but not sufficient for classification. Based on read-across the target substance sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, ammonium salts (CAS 90583-11-2) is also not classified for skin sensitisation. No data available for respiratory sensitisation.
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