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EC number: 701-341-4 | 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
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Data from GPMT study was available and it demonstrated that the test material was a skin sensitizer. LLNA data on constituents was also provided in the dossier to provide additional information.
Test material
- Reference substance name:
- Phosphorous acid, diphenyl isodecyl ester
- Molecular formula:
- C22H31O3P
- IUPAC Name:
- Phosphorous acid, diphenyl isodecyl ester
- Reference substance name:
- Triphenyl phosphite
- EC Number:
- 202-908-4
- EC Name:
- Triphenyl phosphite
- Cas Number:
- 101-02-0
- Molecular formula:
- C18H15O3P
- IUPAC Name:
- triphenyl phosphite
- Reference substance name:
- Diisodecyl phenyl phosphite
- EC Number:
- 247-098-3
- EC Name:
- Diisodecyl phenyl phosphite
- Cas Number:
- 25550-98-5
- Molecular formula:
- C26H47O3P
- IUPAC Name:
- Reaction products of triphenyl phosphite and isodecanol (1:2)
- Reference substance name:
- Grouped, low level constituents (1) - see description
- Molecular formula:
- C21H29O3P and C23H33O3P
- IUPAC Name:
- Grouped, low level constituents (1) - see description
- Reference substance name:
- Grouped, low level constituents (2) - see description
- Molecular formula:
- N/A
- IUPAC Name:
- Grouped, low level constituents (2) - see description
- Reference substance name:
- Triisodecyl phosphite
- EC Number:
- 246-998-3
- EC Name:
- Triisodecyl phosphite
- Cas Number:
- 25448-25-3
- Molecular formula:
- C30H63O3P
- IUPAC Name:
- Phosphorus acid, triisodecyl ester
- Reference substance name:
- Grouped, low level constituents (3) - see description
- Molecular formula:
- N/A
- IUPAC Name:
- Grouped, low level constituents (3) - see description
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Constituent 6
Constituent 7
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- water
- Concentration / amount:
- Induction: 0.1 DPDP v/v (injection) and 25% v/v (dermal)
Challenge 1: 10% DPDP v/v
Challenge 2: 2% DPDP v/v
Challenge 3: 5% DPDP v/v
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- Induction: 0.1 DPDP v/v (injection) and 25% v/v (dermal)
Challenge 1: 10% DPDP v/v
Challenge 2: 2% DPDP v/v
Challenge 3: 5% DPDP v/v
- No. of animals per dose:
- 10
- Details on study design:
- Induction injections included both the use of Freund's adjuvant 50/50 in water and just the test material without adjuvant.
- Challenge controls:
- No controls
- Positive control substance(s):
- no
Results and discussion
- Positive control results:
- Dermal irritation was observed after induction at those sites injected with Freund's adjuvant and a mixture of DPDP with Freund's adjuvant. DPDP on its own did not cause irritation at the injection site
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10% v/v
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Erythema and slight oedema observed in positive responses.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10% v/v. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: Erythema and slight oedema observed in positive responses..
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10% v/v
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- Erythema scores stayed the same and oedema scores generally increased.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% v/v. No with. + reactions: 8.0. Total no. in groups: 10.0. Clinical observations: Erythema scores stayed the same and oedema scores generally increased..
- Reading:
- 1st reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 10% v/v
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Increase in erythema and oedema response in 4 of the 7 positive animals.
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10% v/v. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: Increase in erythema and oedema response in 4 of the 7 positive animals..
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 2% v/v
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- Erythema and slight oedema observed.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 2% v/v. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: Erythema and slight oedema observed..
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 2% v/v
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- Clinical responses generally lessened from 24 hours.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 2% v/v. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: Clinical responses generally lessened from 24 hours..
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 2% v/v
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- Responses continued to lessen from 24 and 48 hrs.
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 2% v/v. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: Responses continued to lessen from 24 and 48 hrs..
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5% v/v
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Clinical observations:
- General slight to moderate erythema and oedema.
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 24.0. Group: test group. Dose level: 5% v/v. No with. + reactions: 9.0. Total no. in groups: 10.0. Clinical observations: General slight to moderate erythema and oedema..
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5% v/v
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Some severe to moderate response in several animals.
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 5% v/v. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: Some severe to moderate response in several animals..
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 5% v/v
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Clinical observations:
- Response levels similar to those at 48 hrs.
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 72.0. Group: test group. Dose level: 5% v/v. No with. + reactions: 7.0. Total no. in groups: 10.0. Clinical observations: Response levels similar to those at 48 hrs..
Any other information on results incl. tables
The first challenge application showed a mix of responses from none to mild to moderate erythema and oedema. In an attempt to clarify whether the reactions from the first challenge were skin sensitisation or irritation, the study conducted subsequent challenges at lower concentrations. In the second challenge slight to well-defined dermal reactions occurred in 6 to 10 animals. In the third challenge well-defined to moderate in 5 animals, increasing to severe responses in several animals. Slight to moderate responses were seen in the other guinea pigs, except for one animal that showed no response.
Applicant's summary and conclusion
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Positive dermal reactions were seen in 6 to 9 guinea pigs during the series of challenges. The study authors noted that the responses were "not entirely typical" of reactions typically seen in a sensitisation study and might have been due to irritation. The report does not state that DPDP is definitively a skin sensitizer, but the results (in consideration of other data on phosphites) appear to be indicative of skin sensitisation.
- Executive summary:
Positive dermal reactions were seen in 6 to 9 guinea pigs during the series of challenges. The study authors noted that the responses were "not entirely typical" of reactions typically seen in a sensitisation study and might have been due to irritation. The report does not state that DPDP is definitively a skin sensitizer, but the results (in consideration of other data on phosphites) appear to be indicative of skin sensitisation. The substance is being classified as a skin sensitiser.
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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