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EC number: 812-497-9 | CAS number: 1893414-79-3
- 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
Under the present test conditions, the reada cross source substance Phosphoric acid, C8-10-branched and linear alkyl esters, compds. with diethanolamine revealed no sensitising properties in guinea pigs in a test model according to Magnusson and Kligman. The results of the source substance are considered relevant for human health endpoint skin sensitization and consecutive risk assessment of the target substance (see supporting document on justification of read across approach).
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
- Study period:
- 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Presented OECD 406 GPMT study was initially conducted for non-REACH related use for a structural analogue of the registered substance.
In order to avoid further vertebrate animal testing (i.e. conduct a new OECD 429 LLNA) this OECD 406 study is presented within a read across approach (structural analogue; one-to-one read-across).
The source GPMT study was conducted with Phosphoric acid, C8-10-branched and linear alkyl esters, compds. with diethanolamine. The read across source substance is considered a structural analogue by taking into account 1. physico-chemical properties (surface active properties, logKow, water solubility) and a similar chemical structure of the test item's anionic organic moiety (i.e. mono-, di- and pyrophosphoric acid esters of linear and branched fatty alcohols C8-10). The diethanolammonium cation is considered not of toxicological relevance regarding the endpoint skin sensitization due to the fact that this substance (diethanolamine) is not known as a skin sensitizer in animals and available information in humans suggests no such effects. The remaining uncertainties as well as the limitations of the presented GPMT study were considered acceptable to cover the endpoint with sufficient confidence. The results of the source substance are considered relevant for human health endpoint skin sensitization and consecutive risk assessment of sensitizing effects (see supporting document on justification of read across approach). - Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- - no results on positive control reported. - FCA mixture preapred with paraffin not water or saline. - Temperature range 20 - 25 °C. - minor methodical deviations due to pre-OECD 406 guidance release execution date of study
- Principles of method if other than guideline:
- Study according to Magnusson B. and Kligman A.M.
- GLP compliance:
- not specified
- Remarks:
- Statement on periodic checks by quality control unit attached to the study report.
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Presented GPMT study was initially conducted for non-REACH related use for a structural analogue of the registered substance.
In order to avoid further vertebrate animal testing (i.e. conduct a new OECD 429 LLNA) this OECD 406 study is presented within a read across approach (structural analogue; one-to-one read-across).
The source GPMT study was conducted with Phosphoric acid, C8-10-branched and linear alkyl esters, compds. with diethanolamine. The read across source substance is considered a structural analogue by taking into account 1. physico-chemical properties (surface active properties, logKow, water solubility) and a similar chemical structure of the test item's anionic organic moiety (i.e. mono-, di- and pyrophosphoric acid esters of linear and branched fatty alcohols C8-10 (source) and C14-15 (target). The diethanolammonium cation is considered not of toxicological relevance regarding the endpoint skin sensitization due to the fact that this substance (diethanolamine) is not known as a skin sensitizer in animals and available information in humans suggests no such effects. The remaining uncertainties as well as the limitations of the presented GPMT study were considered acceptable to cover the endpoint with sufficient confidence. The results of the source substance are considered relevant for human health endpoint skin sensitization and consecutive risk assessment of sensitizing effects (see supporting document on justification of read across approach). - Specific details on test material used for the study:
- Name: Phosphoric acid, C8-10-branched and linear alkyl esters, compds. with diethanolamine
CAS No.: 97467-95-3
Physical state: white solid at 20 °C - Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Species / Strain: Guinea pig / Pirbright white
Breeder: Winkelmann
Number of animals: 20
Sex: Female
Age (at start of administration): 29 days
Body weight (at start of administration): 330 – 480 g
Identification of animals: By cage label and coloured marks
Adaptation period: At least 5 days
Diet
Commercial diet Altromin served as food. This food was offered ad libitum. This diet contains an adequate amount of ascorbic acid as required by the OECD Testing Guideline 406.
Housing
The animals were kept in groups of 5 in MAKROLON cages at a room temperature of 20°C - 25 °C (maximum range) and a relative humidity of 45% - 75% (maximum range). Rooms were lit on a 12-hour light/12-hour dark cycle.
Granulated textured wood was used as bedding material in the cages. The cages were changed and cleaned twice a week.
Drinking water
Tap water (in drinking bottles) was offered ad libitum. - Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.1 mL of a 1 % dispersion of test item in paraffin DAB 8
- Day(s)/duration:
- 0 d
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.1 mL of test item mixture (mixture of FCA and test item in paraffin DAB 8; end concentration of test item 1% and 50 % FCA)
- Day(s)/duration:
- 0 d
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- intradermal
- Vehicle:
- paraffin oil
- Concentration / amount:
- 0.1 ml of Freund's complete adjuvant (FCA) diluted 1 : 1 paraffin DAB 8 (50 % FCA).
- Day(s)/duration:
- 0 d
- Adequacy of induction:
- other: adjuvant
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 20% concentration / 0.5 mL of the test preparation was spread over a wound plaster (Hansapor steril) and applied to the test area and held in contact by an occlusive dressing.
- Day(s)/duration:
- 7 d / 48 h
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- 2% concentration / 0.1 ml of the test preparation was spread over wound plaster (6 cm2) and applied to the test area and held in contact by an occlusive dressing
- Day(s)/duration:
- 21 d / 24 h; assessment of skin reaction after further 24h and 48h.
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20 test and 10 control animals were used.
- Details on study design:
- Preexperiments showed that 1 per cent respectively 20 per cent substance was minimal irritating (intracutaneous and epicutaneous) and 2 per cent substance was the maximal non-irritating dose (epicutaneous) on the skin of guinea pigs. Paraffine perliquid DAB 8 was always utilized as vehicle.
The body weight was analysed statistically using STUDENT's t-test (p ≤ 0.01). - Challenge controls:
- The vehicle control animals were treated in the same way as the animals of the test group, but received the vehicle paraffin DAB 8 instead of the test item and no injection of vehicle and FCA mixture.
- Positive control substance(s):
- not specified
- Remarks:
- not specified
- Positive control results:
- The vehicle control revealed no skin reactions.
Positive control: not specified - Key result
- Reading:
- other: positive control
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Key result
- Reading:
- other: negative control
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Behaviour remained unchanged during the course of the study.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- other: negative control
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- Behaviour remained unchanged during the course of the study.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2 mL of a 1% solution of the test item in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Behaviour remained unchanged during the course of the study.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 2 mL of a 1% solution of the test item in water
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- Behaviour remained unchanged during the course of the study.
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the present test conditions, Phosphoric acid, C8-10-branched and linear alkyl esters, compds. with diethanolamine revealed no sensitising properties in guinea pigs in a test model according to Magnusson and Kligman.
- Executive summary:
The purpose of this study was to determine the potential of the test item to produce skin sensitisation reactions in guinea pigs in a test model according to the Magnusson and Kligman method. A 1% solution of the test item in water chosen for the 1st (intracutaneous) induction stage revealed a moderate and confluent erythema 24 and 48 hours after administration in all 10 test item-treated animals. 2 mL of a 25% suspension of water/animal chosen for the 2nd (topical) induction revealed a moderate and confluent erythema 24 and 48 hours after administration in all 10 test item-treated animals. The challenge with 2 mL of a 1% solution of the test item/animal revealed no skin irritation in any animal and, thus, the test item had no sensitising properties. The vehicle control revealed no skin reactions. Animals of the same strain treated with alpha-hexyl cinnamic aldehyde in sesame oil exhibited a sensitising reaction in all animals in form of a moderate and confluent erythema (grade 2, 48 hours after start of exposure) and a discrete or patchy erythema (grade 1, 72 hours after start of exposure). The body weight gain of the animals treated with test item was within the range of the vehicle control during the experiment. Behaviour remained unchanged during the course of the study. Under the present test conditions, Phosphoric acid, C8-10-branched and linear alkyl esters, compds. with diethanolamine revealed no sensitising properties in guinea pigs in a test model according to Magnusson and Kligman.
Reference
Method
The test item was tested for its sensitization potential on the skin using a maximization method [according to Magnusson, B. and Kligman, A.M., J. Invest. Dermatol. 52, 268-276 (1969)]. In the test 36 guinea pigs from the strain: Pirbright white were used (2 x 3 animals for preexperiments, 20 substance animals and 10 control animals).
Preexperiment
Preexperiments showed that 1 per cent respectively 20 per cent substance was minimal irritating (intracutaneous and epicutaneous) and 2 per cent substance was the maximal non-irritating dose (epicutaneous) on the skin of guinea pigs.
Main experiment
Paraffine perliquid DAB 8 was always utilized as vehicle. After intracutanous and epicutanous (occlusive/48 h) application, using the minimal irritating concentration of the substance, the retreatment was performed by application (occlusive/24 h) of the maximum non-irritating concentration. According to the test results obtained, the substance test item can be regarded as a "very slightly sensitizer" for guinea pigs (not sufficient for classification).
None of the test animals died prematurely. No test item-related differences in body weight and body weight gain were noted between the test animals of the control group and the test animals treated with the test item.
Table 1: Main experiment - assessment of skin reactions
Animal / cage no. | hours after | |||||
intracutaneous induction | intracutaneous induction | epicutaneous induction | epicutaneous induction | 1st topical challenge | 2nd topical challenge | |
1 h | 24 h | 1 h | 24 h | 24 h | 48 h | |
1 / 1 | 1 | 2 | 1 | 0 | 0 | 0 |
2 / 1 | 1 | 1 | 1 | 1 | 0 | 0 |
3 / 1 | 1 | 2 | 1 | 1 | 0 | 0 |
1 / 2 | 1 | 1 | 1 | 1 | 0 | 0 |
2 / 2 | 1 | 1 | 1 | 1 | 1 | 1 |
3 / 2 | 1 | 1 | 1 | 1 | 0 | 0 |
1 / 3 | 1 | 1 | 1 | 1 | 1 | 0 |
2 / 3 | 1 | 2 | 1 | 1 | 1 | 1 |
3 / 3 | 1 | 2 | 1 | 1 | 0 | 0 |
1 / 4 | 1 | 1 | 1 | 1 | 0 | 1 |
2 / 4 | 1 | 1 | 0 | 1 | 1 | 0 |
3 / 4 | 1 | 2 | 1 | 1 | 0 | 0 |
1 / 5 | 1 | 2 | 1 | 1 | 0 | 0 |
2 / 5 | 1 | 2 | 1 | 1 | 0 | 0 |
3 / 5 | 1 | 2 | 1 | 1 | 0 | 0 |
1 / 6 | 1 | 1 | 2 | 1 | 0 | 0 |
2 / 6 | 1 | 2 | 1 | 1 | 0 | 0 |
3 / 6 | 1 | 2 | 1 | 1 | 0 | 0 |
1 / 7 | 1 | 1 | 0 | 1 | 0 | 0 |
2 / 7 | 1 | 1 | 1 | 1 | 0 | 0 |
Table 2: Control group - assessment of skin reactions
Animal / cage no. | hours after | |||||
intracutaneous induction | intracutaneous induction | epicutaneous induction | epicutaneous induction | 1st topical challenge | 2nd topical challenge | |
1 h | 24 h | 1 h | 24 h | 24 h | 48 h | |
1 / 8 | 1 | 1 | 0 | 0 | 0 | 0 |
2 / 8 | 0 | 1 | 0 | 0 | 0 | 0 |
3 / 8 | 0 | 1 | 0 | 0 | 0 | 0 |
1 / 9 | 0 | 1 | 0 | 0 | 0 | 0 |
2 / 9 | 1 | 1 | 0 | 0 | 1 | 0 |
3 / 9 | 0 | 0 | 0 | 0 | 0 | 0 |
1 / 10 | 0 | 0 | 0 | 0 | 0 | 0 |
2 / 10 | 0 | 0 | 0 | 0 | 0 | 0 |
1 / 11 | 0 | 0 | 0 | 0 | 0 | 0 |
2 / 11 | 1 | 0 | 0 | 0 | 0 | 0 |
Draize dermal irritation scoring system:
Skin reaction | Score |
no skin reaction | 0 |
very slight erythema | 1 |
well defined erythema | 2 |
moderate to severe erythema | 3 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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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