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EC number: 418-310-3 | CAS number: 126050-54-2
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7 February 1989 to 2 March 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance with US EPA test guidelines in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Acute Exposure Oral Toxicity," Health Effects Test Guidelines, U. S. Environmental Protection Agency Office of Pesticide and Toxic Substances, pp. 22-31, October 1984.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test Material: HP-10 [Phosphorus acid, 2.2 methyiene bis-(4.6.di-t-butyl phenyl)2 ethyl hexyl ester]
Physical Description: White powder
Purity and Stability: Sponsor assumes responsibility for purity and stability determinations (including under test conditions).
Storage and Retention: The test material was stored at room temperature.
Any unused material will be discarded according to HLA Standard Operating Procedure.
Safety Precautions: Normal handling procedures were used according to HLA Standard Operating Procedure.
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD®(SD)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Young adult male and female albino rats of the Crl:CD®(SD)BR strain (approximately 8 weeks of age) were procured, separated by sex, maintained in group cages in temperature- and humidity-controlled quarters, provided continuous access to Rodent Chow® 5001, Purina Mills, Inc., and water and held for an acclimation period of at least 7 days. Animal husbandry and housing at HLA comply with standards outlined in the "Guide for the Care and Use of Laboratory Animals". If variations from the prescribed environmental conditions existed, they were documented and considered to have no effect on the study outcome. No contaminants were expected to have been present in the feed or water which would have interfered with or affected the results of the study.
All animals were chosen at random, treated, and maintained during the observation period as specified for the acclimation period and were identified by animal number and corresponding ear tag. Food and water were available ad libitum throughout the study, except for an overnight period just before test material administration when food, but not water, was withheld.
Reason for Species Selection: Historically, rats have been used as a representative of a rodent species and are preferred by various regulatory agencies.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- Preparation and Administration of Test Material: For the range-finding study, the test material was mixed with corn oil to a uniform suspension at a specific concentration for each dose level. For the definitive study, the test material was mixed with corn oil to a uniform suspension at a concentration of 500 mg/ml. An individual dose was calculated for each animal based upon its fasted body weight and administered at a dose volume of 10 ml/kg by gavage. Each test material mixture was stirred with a stir plate and magnetic stir bar during dosing to maintain a uniform suspension.
Reason for Route of Administration: This is the method for administering a known quantity of test substance and has been the route of choice historically. - Doses:
- Range-finding dose levels of 50, 100, 1,000, 2,500, and 5,000 mg/kg of body weight (one male and one female/dose level).
Based on the results of this range-finding study, in the definitive LD50 study animals were treated at a single level of 5,000 mg/kg of body weight. - No. of animals per sex per dose:
- Range finding study - one male/one female per dose level.
Definitive study - five males & five females. - Control animals:
- no
- Details on study design:
- Initially, five male and five female acclimated rats, weighing from 202 to 259 g, were used for five range-finding dose levels of 50, 100, 1000, 2500, and 5,000 mg/kg of body weight (one male and one female/dose level).
These range-finding animals were housed individually.
Based on the results of this range-finding study, five male and five female rats, weighing from 215 to 282 g, were used for the definitive LD50 study.
Animals were treated at a single level of 5,000 mg/kg of body weight. These definitive study animals were housed by sex in groups of five.
Observations: The range-finding study animals were observed for clinical signs and mortality at 1, 2, 4, 24, 48 and 72 hours after treatment. The definitive study animals were observed for clinical signs and mortality at 1, 2 and 4 hours after test material administration. These animals were observed daily thereafter for 14 days for clinical signs and twice daily for mortality.
All animals were weighed just before test material administration. Body weights of definitive study animals were taken again at 7 and 14 days.
Pathology: All range-finding study animals were sacrificed at termination and discarded. All definitive study animals, were sacrificed at termination, subjected to a gross necropsy examination and all abnormalities were recorded. After necropsy, animals were discarded and no tissues were saved. - Statistics:
- Statistical Methods: No statistical method was performed.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- Diarrhoea was observed in three of the five female animals on the day of dosing.
- Body weight:
- There was no significant effect on body weight gain.
- Gross pathology:
- No visible lesions were recorded at the time of necropsy.
Any other information on results incl. tables
Range-Finding Mortality Summary
Dose Level (mg/kg) |
Hours |
|||||||
0-4 |
24 |
48 |
72 |
|||||
Male |
Female |
Male |
Female |
Male |
Female |
Male |
Female |
|
50 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
100 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1000 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
2500 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
5000 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
DEFINITIVE STUDY
Sex |
Dose Level (mg/kg) |
Average Body Weights (g) |
Mortality (Number Dead/Number Dosed) |
||
Initial |
Day 7 |
Terminal |
|||
Male |
5000 |
266 |
343 |
377 |
0/5 |
Female |
5000 |
230 |
259 |
264 |
0/5 |
Clinical Signs (Number of Animals Affected)
Observation |
Hours |
Days |
|||||||||||||||
1.0 |
2.0 |
4.0 |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
13 |
14 |
|
Males (5000 mg/kg) |
|||||||||||||||||
Appeared normal |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
Females (5000 mg/kg) |
|||||||||||||||||
Appeared normal |
2 |
2 |
2 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
Diarrhoea |
3 |
3 |
3 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
PATHOLOGY
Animal Number |
Test Day |
|||
Sex |
Died |
Sacrificed |
Necropsy Comment |
|
Dose Level : 5000 mg/kg of Body Weight |
||||
C30518 |
M |
- |
14 |
No visible lesions |
C30520 |
M |
- |
14 |
No visible lesions |
C30517 |
M |
- |
14 |
No visible lesions |
C30516 |
M |
- |
14 |
No visible lesions |
C30547 |
M |
- |
14 |
No visible lesions |
C30321 |
F |
- |
14 |
No visible lesions |
C30322 |
F |
- |
14 |
No visible lesions |
C30323 |
F |
- |
14 |
No visible lesions |
C30324 |
F |
- |
14 |
No visible lesions |
C30325 |
F |
- |
14 |
No visible lesions |
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The estimated oral LD50 was determined to be >5,000 mg/kg of body weight for males, females and the combined sexes.
- Executive summary:
The acute oral toxicity of HP-10 was evaluated in male and female rats.
This study was conducted in accordance with the Environmental Protection Agency's Good Laboratory Practice Standards, 40 CFR 792 and"Acute Exposure Oral Toxicity," Health Effects Test Guidelines, U. S.Environmental Protection Agency Office of Pesticide and ToxicSubstances, pp. 22-31, October 1984.
The estimated oral LD50was determined to be >5,000 mg/kg of body weight for males, femalesandthe combined sexes. Diarrhoea was observed in three of the five female animals on the day of dosing. There was no significant effect on body weight gain. No visible lesions were recorded at the time of necropsy.
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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