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EC number: 410-290-4 | CAS number: 80693-00-1 ADK STAB PEP-36
- 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:
- 30 September 1991 to 13 January 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study in accordance with internationally recognised guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane
- EC Number:
- 410-290-4
- EC Name:
- 3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane
- Cas Number:
- 80693-00-1
- Molecular formula:
- Hill formula: C35H54O6P2 CAS formula: C35H54O6P2
- IUPAC Name:
- 3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): ADK STAB PEP-36
- Physical state: White powder
- Purity: >99%
- Lot/batch No.: L-10181
- Expiration date of the lot/batch: 1 August 1992
- Storage condition of test material: At room temperature (approximately 20°C)
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: biological research laboratory
- Age at study initiation: 8 weeks (including acclimatisation)
- Weight at study initiation: pre-test 320 - 344 g, start of acclimatisation control and test group 302 - 371 g
- Housing: individually in Makrolon type-3 cages (size: 27 x 42 x 15 cm) with standard softwood bedding
- Diet: pelleted standard guinea pig breeding/maintenance diet, ad libitum
- Water: community tap water, ad libitum. Once weekly additional supply of ascorbic acid (1g/l) via drinking water
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3°C
- Humidity (%): 40-70
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12
IN-LIFE DATES: From: 7 October 1901 To: 31 October 1991
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: vaselinum album
- Concentration / amount:
- Pre-test:
1) Intradermal: 5, 3 and 1% in ethanol
2) Epidermal: 25, 15, 10, 5 % in vaselinum
Main test:
Intradermal: 5% in ethanol
Epidermal: 25% in vaselinum
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaselinum album
- Concentration / amount:
- Pre-test:
1) Intradermal: 5, 3 and 1% in ethanol
2) Epidermal: 25, 15, 10, 5 % in vaselinum
Main test:
Intradermal: 5% in ethanol
Epidermal: 25% in vaselinum
- No. of animals per dose:
- Number of animals in test group: 20
Number of animals in negative control group: 10 - Details on study design:
- RANGE FINDING TESTS:
To identify irritant concentrations for induction phase of main study and non-irritant concentration by topical route for challenge application.
Intradermal injection - 5, 3 and 1% in ethanol. Dermal reactions assessed after 24 hours. 5% test substance in ethanol was selected for intracutaneous induction in the main study.
Epidermal application - 25, 15, 10 and 5%. Assessed for erythema and oedema 24 hours and 48 hours after exposure. 25% test substance in ethanol was selected for the main study.
MAIN STUDY
A. INDUCTION EXPOSURE
Intradermal
- No. of exposures: 6 exposure sites (3 pairs) per animal
- Exposure period: 7 days
- Test groups:
i)) Freund's complete adjuvant 50:50 with physiological saline.
ii) The test article, diluted to 5% with ethanol
iii) The test article diluted to 5% by emulsion in a 50:50 mixture of Freund's complete adjuvant and physiological saline.
- Control group:
1) Freund's complete adjuvant 50:50 with physiological saline.
2) Ethanol.
3) Freund's complete adjuvant 50:50 with physiological saline.
- Site: scrapular region
- Frequency of applications: 1
- Duration: 7 days
- Concentrations: 5 % test substance in ethanol
Epidermal
On day 7 of the test and approximately 24 hours prior to the epidermal application the scapular area (approximately 6 x 8 cm) was clipped, shaved free of hair and the test areas were pre-treated with 10% Sodium-Lauryl-Sulfate (SLS) in petrolatum oil because no primary irritation concentration could be determined in the corresponding pre-test. The SLS was massaged into the skin with a glass rod without bandaging. This SLS-concentration enhances sensitization by provoking a mild inflammatory reaction.
On day 8 a 2 x 4 cm patch of filter paper was covered with a thin layer of the selected test article concentration (25% in vaselinum album) and placed over the injection sites of the test animals. The patch was covered by aluminum foil and firmly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The dressings were left
in place for approximately 48 hours. The epidermal application procedure described ensured intensive contact of the test article.
The guinea-pigs of the control group were treated as described above with the omission of test article (vaselinum album only).
Reaction sites were assessed for erythema and oedema 24 and 48 hours after removal of the dressing, using the numerical grading system according to Draize.
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: two weeks after epidermal exposure
- Exposure period: 24 hours
- Test groups:
i) non-irritant concentration of the test article (25% in vaselinum album
ii) vaselinum album only
- Control group: treated in the same way as the test groups described above.
- Site: 5 x 5 cm area on the left and right flank
- Concentrations: 25%
- Evaluation (hr after challenge): 24 and 48 hours
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Evidence of sensitisation of each challenge concentration:
A 25 % 0
A 0 % 0
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- From the results described above no allergenic potency of the test substance was concluded. The results were interpreted according to the rating of Magnusson and Kligman (1969).
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