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EC number: 223-276-6 | CAS number: 3806-34-6
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26 August 1993 to 9 September 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-2 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.1100 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- O,O'-dioctadecylpentaerythritol bis(phosphite)
- EC Number:
- 223-276-6
- EC Name:
- O,O'-dioctadecylpentaerythritol bis(phosphite)
- Cas Number:
- 3806-34-6
- Molecular formula:
- C41H82O6P2
- IUPAC Name:
- 3,9-bis(octadecyloxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane
- Test material form:
- solid: flakes
- Details on test material:
- - Name of test material (as cited in study report): Distearyl pentaerythritol diphosphite
- Physical state: solid (white flakes)
- Storage condition of test material: away from heat and ignition sources in a dry place at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hazletown Research Products, Inc., Denver, Pennsylvania
- Age at study initiation: approximately 11 weeks
- Weight at study initiation: 2098 - 2240 g
- Housing: individually
- Diet: Purina® Certified Rabbit Chow® #5322 (ad libitum)
- Water: tap water (ad libitum)
- Acclimation period: 6 days (minimum)
ENVIRONMENTAL CONDITIONS
- Temperature: 65 - 72 °F
- Humidity: 60 - 82 %
- Photoperiod: 12 hours light / 12 hours dark
IN-LIFE DATES: From 26 August 1993 to 9 September 1993
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: on the day before dosing, hair from the back of the rabbits was removed using animals clippers. The animals were also shaved, to aid dermal observations, on study days 3, 7, 10 and 14.
- % coverage: 13 - 15 % of total body surface
- Type of wrap if used: doses were applied under gauze binders and secured with Dermiform® tape
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: no - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality and clinical signs were observed at approximately 1.0, 3.0 and 4.0 hours post-dose and on day 0 and twice daily thereafter for 14 days. Dermal observations were made 30-60 minutes after bandage removal and daily thereafter for 13 days. Bodyweights were recorded on study days 0, 7 and 14.
- Necropsy of survivors performed: yes (examination of major organ systems of the cranial, thoracic and abdominal cavities)
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No signs of toxicity were observed at this dose level.
- Mortality:
- None of the animals died during the study.
- Clinical signs:
- other: 2 females had a soft stool on day 1. 2 animals had their collars caught in their mouth during test material exposure and one of these animals had wet red material around the mouth. There were no other clinical findings.
- Gross pathology:
- Accessory splenic tissue, a common congenital abnormality in this strain of rabbit, was noted for 5 animals. No other gross necropsy findings were recorded.
- Other findings:
- The test material induced very slight to moderate erythema on all rabbits and very slight oedema on 8 rabbits. Desquamation was present on eight sites by day 7 and one site by day 14. There were no other dermal findings. Three sites had very slight erythema and/or desquamation at study termination on day 14.
Any other information on results incl. tables
Table 1: Bodyweights and Mortality
Day |
Males |
Females |
||
Bodyweight (g) (mean) |
Mortality |
Bodyweight (g) (mean) |
Mortality |
|
0 |
2170 |
0/5 |
2165 |
0/5 |
7 |
2505 |
0/5 |
2420 |
0/5 |
14 |
2739 |
0/5 |
2640 |
0/5 |
Table 2: Individual dermal observations
Day |
|||||||||||||||
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
||
16496 |
Erythema |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
SNR |
SNR |
1 |
Oedema |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Other findings |
- |
- |
- |
- |
- |
- |
d |
- |
- |
- |
- |
- |
|||
16498 |
Erythema |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
SNR |
1 |
1 |
SNR |
SNR |
SNR |
Oedema |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||
Other findings |
- |
- |
- |
- |
- |
d |
d |
- |
- |
- |
|||||
16503 |
Erythema |
3 |
1 |
1 |
1 |
1 |
1 |
0 |
0 |
SNR |
SNR |
SNR |
SNR |
SNR |
SNR |
Oedema |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||||
Other findings |
- |
- |
- |
d |
d |
d |
d |
d |
|||||||
16507 |
Erythema |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
Oedema |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Other findings |
- |
- |
- |
d |
d |
d |
d |
d |
- |
- |
- |
- |
- |
d |
|
16508 |
Erythema |
2 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
SNR |
SNR |
Oedema |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||
Other findings |
- |
- |
- |
d |
d |
d |
d |
d |
- |
- |
- |
- |
|||
16523 |
Erythema |
2 |
SNR |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
SNR |
SNR |
SNR |
SNR |
SNR |
Oedema |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||||
Other findings |
- |
- |
- |
- |
d |
d |
- |
- |
|||||||
16524 |
Erythema |
3 |
1 |
1 |
1 |
1 |
1 |
0 |
SNR |
SNR |
SNR |
SNR |
SNR |
SNR |
SNR |
Oedema |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
||||||||
Other findings |
- |
- |
- |
- |
- |
d |
d |
||||||||
16530 |
Erythema |
1 |
SNR |
1 |
1 |
1 |
1 |
0 |
0 |
0 |
SNR |
SNR |
SNR |
SNR |
SNR |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||||
Other findings |
- |
- |
- |
- |
- |
d |
d |
d |
|||||||
16533 |
Erythema |
1 |
SNR |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
SNR |
SNR |
SNR |
0 |
Oedema |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|||||
Other findings |
- |
- |
- |
- |
- |
- |
- |
- |
- |
d |
|||||
16536 |
Erythema |
1 |
SNR |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
1 |
SNR |
SNR |
SNR |
SNR |
Oedema |
1 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
||||||
Other findings |
- |
- |
- |
- |
- |
- |
- |
- |
- |
||||||
d = Desquamation SNR = Scored, not remarkable |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, there were no deaths, clinical signs of toxicity, remarkable bodyweight changes of test material related gross necropsy findings.The test material induced very slight to moderate erythema on all rabbits and very slight oedema on 8 rabbits. Nine sites had desquamation within 2 weeks after dosing. Dermal irritation decreased over the period with three rabbits having very slight erythema and/or desquamation at study termination on day 14. There was no sign of systemic toxicity among the rabbits. based on the data obtained, the acute dermal LD50 of the test material in the albino rabbit was determined to be in excess of 2000 mg/kg.
- Executive summary:
The acute dermal toxicity of the test material was determined in accordance with standardised guidelines OECD 402, US EPA OPP 81 -2 and US EPA OPPTS 798.1100. During the study rabbits were administered with a single dermal dose of test material which was held in place, under a semi-occlusive dressing, for a period of 24 hours. Following exposure to the test material, animals were observed for 14 days for mortality and clinical signs. All surviving animals were necropsied on day 14. Under the conditions of the study, there were no deaths, clinical signs of toxicity, remarkable bodyweight changes of test material related gross necropsy findings.The test material induced very slight to moderate erythema on all rabbits and very slight oedema on 8 rabbits. Nine sites had desquamation within 2 weeks after dosing. Dermal irritation decreased over the period with three rabbits having very slight erythema and/or desquamation at study termination on day 14. There was no sign of systemic toxicity among the rabbits. based on the data obtained, the LD50 of the test material was determined to be in excess of 2000 mg/kg.
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