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EC number: 242-768-1 | CAS number: 19035-79-1
- 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
The test item revealed no skin sensitizing properties in a Buehler test and an open epicutaneous study performed according to OECD guideline 406. Results of the animal studies are in line with results obtained from a patch test performed with human subjects.
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:
- 2005-03-15 until 2005-04-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- adopted 1996-07-30
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted 1992-07-17
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- The guinea pig test method described in OECD TG 406 provides suitable information for hazard identification.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg Germany
- Weight at study initiation: mean weight 381 g
- Housing: Individually in transparent macrolon cages (type IV) on soft wood granulate in on air-conditioned room. 3 or 2 animals per cage
- Diet: ssniff Ms-H (V 2233), ad libitum
- Water: tap water in plastic bottles, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 50 ± 20 %
- Photoperiod: 12 hours light / dark - Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- Induction (epicutaneous): 100 % (moistened)
Challange (epicutaneous): 100 % (moistened) - Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil
- Concentration / amount:
- Induction (epicutaneous): 100 % (moistened)
Challange (epicutaneous): 100 % (moistened) - No. of animals per dose:
- Experimental group: 20 females guinea pigs
Control group: 10 females guinea pigs - Details on study design:
- PRE-TEST:
A pre test was performed in order to determine the non-irritating concentrations of the test substance. No irritation signs (oedema or erythema) were observed with the 100 % (moistened) test substance.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: Day 1, Day 8 and Day 15 (6 hours each)
- Test group: treated with 100 % (moistened) test substance
- Control group: treated with the vehicle
- Site: flank
- Frequency of applications: once a week
- Concentrations: 100 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 29 days after epidermal induction exposure
- Exposure period: 6 hours
- Test group: single treatment
- Control group: single treatment
- Site: flank
- Concentrations: 100 %
- Evaluation (hr after challenge): 24, 48 hours - Positive control substance(s):
- yes
- Remarks:
- Alpha-hexylemnamaldhyde (50% in PEG-40)
- Positive control results:
- The validity of the test system is confirmed by periodically conducted positive control test using in the testing laboratory. The positive control results attached to the report showed the expected positive results.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the present study, none of the twenty animals of the treatment group showed a positive skin response after the challenge procedure. Thus, the percentage of animals reacting positive is below the threshold of 15 %. Based on the results of this study the test substance showed no evidence for sensitizing properties.
- Executive summary:
Skin sensitization testing of the test substance was performed in female guinea pigs in the BUEHLER method B.6 according to EU Method and OECD guideline 406. Dermal induction was performed using 100 % of the test substance moistened with 0.3 mL in sesame oil. The control group was exposed to sesame oil only during induction phase. Challenge treatment was carried out with 100 % of the test substance moistened with 0.3 mL in sesame oil. The validity of the test system was confirmed by a periodically conducted positive control test using Alpha-hexylcinnamaldehyde in a maximization test in the testing laboratory. Based on the results of this study the test substance showed no evidence for sensitizing properties.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitization testing of the test substance was performed in female guinea pigs in the BUEHLER method B.6 according to EU Method and OECD guideline 406. Dermal induction was performed using 100 % of the test substance moistened with 0.3 mL in sesame oil during the induction phase. The control group was exposed to sesame oil only during induction phase. Challenge treatment was carried out with 100 % of the test substance moistened with 0.3 mL in sesame oil. The validity of the test system was confirmed by a periodically conducted positive control test using Alpha-hexylcinnamaldehyde in a maximization test in the testing laboratory. Based on the results of this study the test substance showed no evidence for sensitizing properties. (Aventis, 2000)
The skin sensitisation study on guinea pigs was performed according to OECD guideline 406. For induction, 0.1 mL of the test substance was applied to the shaved flank of the test animals in concentrations of 10, 30, 50, and 70 % of the test substance diluted in water for three weeks (5 times per week). One week after the last induction the animals were challenged at the contralateral flank with 0.025 mL of a 50 % solution of the test substance. An additional 18 animals (control group) also received 0.025 mL of the test substance for challenge without previous induction. Observations for skin reactions were recorded approximately 24 hours after challenge application. Rechallenge was conducted 7 days after the first challenge phase. All animals remained healthy and gained weight during the study. One male died spontaneously on day 24 of the test, but this was not considered treatment related. Repeated applications of 10 % and 30 % concentrations of the test substance were well-tolerated on the guinea pig skin when application sites had been changed weekly, while higher concentrations (50 % and 70 %) caused moderate to strong skin irritation in 1/6 experimental animals of each of the two groups. Challenge tests with 10 %, 30 %, 50 % and 70 % concentrations of the test substance elicited no allergic sensitisation. (RCC, 1987)
The results of the animal studies were supported by the results of a repeated insult (occlusive) patch test procedure in human subjects with 6 % of the test substance (see section 7.10.4). The study showed that the test substance does not induce irritant or allergic contact dermatitis in human subjects.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the results obtained, potassium hexadecyl hydrogen phosphate was not classified and labelled for dermal sensitisation, according to Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) 2019/521.
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