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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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Not reported
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A non-GLP study performed to sound scientific principles with a sufficient level of detail to assess the quality of the submitted data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 972
- Report date:
- 1972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- Principles of method if other than guideline:
- Male and female Charles River albino rats (15 per sex per treatment group) were dosed with the test material in feed for 90 days at concentrations of 0 (control), 300, 1000 and 3000 ppm. Haematology, clinical chemistry and urinalysis were performed on the control and the high dose group on days 45 and 84. Animals were observed for signs of toxicity daily, and bodyweights were measured weekly. At the end of the 90 day period, all animals were necropsied and assessed for signs of systemic toxicity.
- GLP compliance:
- no
- Limit test:
- no
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: crystalline
- Details on test material:
- - Physical state: white crystalline material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Charles River
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., North Wilmington, Mass., USA
- Weight at study initiation: 98-99 g males; 115 g females
- Housing: individually
- Diet: standard rat ration (ad libitum)
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- DIET PREPARATION
- Rate of preparation of diet (frequency): weekly
- Mixing appropriate amounts with (Type of food): diet was prepared by blending the appropriate amount of test material with standard rat ration in a Hobart Mixer - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 300, 1000, 3000 ppm
Basis:
nominal in diet
- No. of animals per sex per dose:
- 15 males and 15 females per dose
- Control animals:
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations checked: abnormal reactions and deaths
BODY WEIGHT: Yes
- Time schedule for examinations: study day 1 and weekly thereafter
FOOD CONSUMPTION: Yes
- Food consumption data were collected for five rats of each sex in every group weekly during the study
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on study days 45 and 84
- Animals fasted: Yes
- How many animals: 10 animals per sex from the control and high dose group
- Parameters examined included: haematocrit value, erythrocyte count, haemoglobin concentration, total leukocyte count and differential leukocyte count
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: on study days 45 and 84
- Animals fasted: Yes
- How many animals: 10 animals per sex from the control and high dose group
- Parameters examined included: blood urea nitrogen concentration, serum alkaline phosphatase activity, serum glutamic-pyruvic transaminase activity and fasted blood glucose concentration
URINALYSIS: Yes
- Time schedule for collection of urine: on study days 45 and 84
- Metabolism cages used for collection of urine: No data
- How many animals: 10 animals per sex from the control and high dose group
- Parameters examined included: glucose concentration, albumin concentration, microscopic elements examination, pH and specific gravity - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
- Weights of the liver, kidneys, spleen, heart and brain of each rat were determined and recorded
HISTOPATHOLOGY: Yes
- The following tissues were stained with Haematoxylin-Eosin and subjected to microscopic examination: oesophagus, stomach (cardia, fundus, pylorus), small intestine (duodenum, jejunum, ileum), cecum, colon, liver, kidneys, spleen, pancreas, urinary bladder, pituitary gland, adrenal gland, testes, seminal vesicle, ovary, bone marrow, thyroid gland, parathyroid gland, salivary gland, prostate gland, heart, aorta, lung, lymph node (cervical, mesenteric), skeletal muscle, peripheral nerve, bone (femur), spinal cord, uterus, trachea, eye, optic nerve and brain (cerebrum, cerebellum and pons). - Statistics:
- Statistical analyses were conducted upon the absolute organ weights and their corresponding ratios to the weight of the body and brain. An Analysis of Variance was conducted first and any significant effects disclosed by that treatment were further studied by t-tests.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- six deaths occurred resulting from trauma incurred during blood collection; they were not considered to be treatment-related.
- Mortality:
- no mortality observed
- Description (incidence):
- six deaths occurred resulting from trauma incurred during blood collection; they were not considered to be treatment-related.
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- A single statistically significant difference in liver to bodyweight ratio was noted although it was not considered to be related to treatment with the test material
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY: Six deaths occurred during the study. All of these deaths resulted from trauma incurred during the collection of blood samples. These deaths occurred in the control as well as the test groups and were not attributed to the ingestion of the test material. There were no untoward behavioural reactions among any of the animals during the study
BODY WEIGHT AND WEIGHT GAIN: No significant differences were noted, in body weights and total weight gains, between test and control rats
FOOD CONSUMPTION: Food consumption was comparable between control and treatment rats
HAEMATOLOGY: No remarkable differences were observed between control and treatment rats
CLINICAL CHEMISTRY: No remarkable differences were observed between control and treatment rats
URINALYSIS: No remarkable differences were observed between control and treatment rats
ORGAN WEIGHTS: A significant difference in liver to bodyweight ratio was observed in rats treated at 3000 ppm, however, the difference was considered to be normal for a random population of albino rats. the lack of any consistent dietary or sex related response indicates that none of the intergroup differences were related to the ingestion of the test material
GROSS PATHOLOGY: No outstanding differences were noted between test and control rats upon gross pathological examination
HISTOPATHOLOGY: Lesions were observed in some animals, most frequently in the trachea and lungs, indicating chronic murine pneumonia. These findings were noted in control as well as treated animals and were therefore considered not to be related to treatment with the test material
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- > 3 000 ppm
- Based on:
- test mat.
- Remarks:
- in diet
- Sex:
- male/female
- Basis for effect level:
- other: No abnormalities observed in any of the parameters tested.
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Table 1: Bodyweight
Dietary level (ppm) |
Sex |
Bodyweight (g) Week: |
Total Average Weight Gain (g/rats) |
|||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
|||
Control |
M |
99 |
153 |
200 |
233 |
299 |
342 |
378 |
399 |
430 |
469 |
491 |
501 |
501 |
520 |
421 |
F |
115 |
151 |
176 |
179 |
215 |
228 |
235 |
252 |
261 |
275 |
263 |
286 |
286 |
295 |
180 |
|
300 |
M |
98 |
149 |
201 |
242 |
301 |
339 |
410 |
428 |
450 |
473 |
497 |
519 |
519 |
531 |
433 |
F |
115 |
146 |
173 |
177 |
207 |
222 |
250 |
257 |
264 |
276 |
279 |
288 |
288 |
296 |
181 |
|
1000 |
M |
98 |
140 |
194 |
225 |
289 |
321 |
386 |
414 |
439 |
466 |
483 |
504 |
504 |
523 |
425 |
F |
115 |
147 |
175 |
179 |
218 |
223 |
252 |
264 |
276 |
289 |
292 |
303 |
303 |
305 |
190 |
|
3000 |
M |
99 |
145 |
201 |
236 |
305 |
347 |
373 |
407 |
432 |
469 |
484 |
509 |
509 |
531 |
432 |
F |
115 |
146 |
175 |
177 |
215 |
227 |
245 |
256 |
268 |
283 |
292 |
295 |
295 |
313 |
198 |
Table 2: Food consumption
Dietary level (ppm) |
Sex |
Food Consumption (g/rat/seven days) Week: |
Total Food Consumption (g/rat) |
|||||||||||||
0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
|||
Control |
M |
163 |
78 |
159 |
171 |
208 |
216 |
234 |
216 |
216 |
229 |
167 |
192 |
189 |
187 |
2409 |
F |
107 |
83 |
137 |
137 |
150 |
157 |
156 |
136 |
136 |
146 |
171 |
132 |
128 |
161 |
1801 |
|
300 |
M |
158 |
96 |
143 |
164 |
191 |
194 |
209 |
184 |
184 |
225 |
151 |
198 |
175 |
212 |
2306 |
F |
114 |
71 |
127 |
126 |
131 |
139 |
128 |
124 |
124 |
140 |
99 |
162 |
113 |
138 |
1612 |
|
1000 |
M |
136 |
105 |
168 |
186 |
198 |
205 |
194 |
204 |
204 |
226 |
163 |
205 |
200 |
240 |
2430 |
F |
106 |
87 |
132 |
141 |
150 |
143 |
148 |
145 |
145 |
148 |
117 |
130 |
133 |
147 |
1727 |
|
3000 |
M |
193 |
105 |
175 |
190 |
211 |
206 |
191 |
195 |
195 |
229 |
194 |
200 |
195 |
222 |
2506 |
F |
117 |
88 |
133 |
138 |
142 |
137 |
154 |
122 |
122 |
151 |
105 |
133 |
127 |
145 |
1692 |
Table 3: Liver organ weight and ratio data (summary of mean values)
Dietary level (ppm) |
Organ Weight (g) |
Organ/bodyweight ratio (g/100 g) |
Organ/brain weight ratio (g/g) |
|||
Male |
Female |
Male |
Female |
Male |
Female |
|
Control |
17.847 |
9.722 |
3.4286 |
3.2918 |
8.8455 |
5.2663 |
300 |
17.975 |
10.121 |
3.3770 |
3.4170 |
9.4797 |
5.6009 |
1000 |
17.392 |
9.829 |
3.3231 |
3.2415 |
9.3762 |
5.5207 |
3000 |
15.769 |
10.006 |
3.0970* |
3.2714 |
8.1530 |
5.6215 |
* Statistically significant at the 95 % Confident level |
Applicant's summary and conclusion
- Conclusions:
- Following continued treatment with test material in the diet for a period of 90 days, no abnormalities were observed in any of the parameters tested. Under the conditions of the test, the no observed effect concentration for albino (Charles River) rats can therefore be concluded to be in excess of 3000 ppm when dosed in the diet.
- Executive summary:
The toxicity of the test material following repeated exposure, over a 90 day period, to rats was investigated following a procedure similar to that outlined in standard guideline OECD 408. During the study, groups of 15 male and 15 female rats were exposed to test material at dietary levels of 300, 1000 and 3000 ppm. Under the conditions of the study, no abnormalities were revealed in bodyweight gain, food consumption, survival or in the hematology, clinical chemistry, urinanalysis and pathology parameters investigated. The no observed effect concentration can therefore be concluded to be in excess of 3000 ppm.
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