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EC number: 252-813-7 | CAS number: 35948-25-5
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP study, pre-dates OECD guidelines and has limitations in design and reporting.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1976
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:
- yes
- Remarks:
- No FOB
- GLP compliance:
- no
- Remarks:
- Pre-dates GLP
- Limit test:
- no
Test material
- Reference substance name:
- HCA
- IUPAC Name:
- HCA
- Reference substance name:
- 9, 10-dihydro-9-oxa-10-phosphaphenanthrene-10-oxide, or 3,4,5,6-dibenzo-1, 2-oxaphosphane-2-oxide
- IUPAC Name:
- 9, 10-dihydro-9-oxa-10-phosphaphenanthrene-10-oxide, or 3,4,5,6-dibenzo-1, 2-oxaphosphane-2-oxide
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): HCA
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approx. 6 week old
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 5
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- The substance was added to the feed which consisted of wheat flour, fish meal, soybean cake, salt, trace minerals, vitamins, thertiary calcium phosphate, soynean oil and corn starch. Full details in the attached report
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 16 weeks
- Frequency of treatment:
- Continuous in feed
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 159, 399, 1023 mg/kg bw/day (males); 0 177, 445, 1094 mg/kg bw/day (females)
Basis:
actual ingested
- Remarks:
- Doses / Concentrations:
0, 0.24, 0.6 and 1.5%
Basis:
nominal in diet
- No. of animals per sex per dose:
- 20
- Control animals:
- yes, plain diet
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: fortnightly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: termination
- Anaesthetic used for blood collection: No data - animals decapitated
- Animals fasted: No data
- How many animals: 10/sex/group
- Parameters examined: red and white cells counts, hemoglobin, hematocrit and differential white cell count.
CLINICAL CHEMISTRY: Yes / No / No data
- Time schedule for collection of blood: termination
- Animals fasted: No data
- How many animals: 10/sex/group
- Parameters examined: GOT, GPT, Al-P, protein, albumin and urea-nitrogen.
URINALYSIS: Yes
- Time schedule for collection of urine: termination
- Metabolism cages used for collection of urine: No data
- Animals fasted: No data
- Parameters examined: Urine protein, sugar and Ph were determined by using urorubstick test paper.
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- Pathological examinations were performed in the heart, liver, kidney, spleen, lung, pancrea, seminal vesicle, ovarine, marrow, stomach, small intestine, large intestine and cecum.
- Statistics:
- Evaluation of the body weight increase, feed intake, organ weight, the morophohematological test and the biochemical test were made by making statistical treatment of the data in conformity with the randomized block design. The number of the dead animals as well as the results of the pathological test were evaluated by performed the X2-test.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- effects observed, treatment-related
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- 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:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Details on results:
- Females in the 1.5% HCA group had a lower food utilisation efficiency.
There were no other effects considered to be related to treatment with HCA
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 023 - 1 094 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: No significant adverse effects at highest dose tested
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Mortality: 2 female animals in the control died at 13 and 16 weeks respectively, 1 male in the group exposed to 0.24% of HCA in the feed died at 8 weeks, 3 males exposied to 0.6% of HCA in the feed died; 1 after 14 weeks and 2 after 15 weeks. 1 female exposed to 1.5% of HCA in the feed died at 8 weeks while one male died at 15 weeks.
Body weight: The animals body weight increased across the test period in line with expectations.
Food consumption: There were no differences between the groups in food consumption.
Food utilisation: The feed requirement ratio was significantly increased in females in group 4 i.e. lower food utilisation efficieny. This is shown in Table 4 of the attached report.
Organ weights: There were no treatment related effects. The weight of the spleen of female animals in the group 3 was lower than that in the controls.
Gross pathology: The anatomic findings revealed that no lesion caused by the administration of HCA was observed as shown in Table 7 of the attached report.
Haematology: The results, as shown in Table 8 of the attached report, showed no significant difference between the groups.
Urinalysis: The result revealed, as shown in Table 9 of the attached report, no significant difference between the groups.
Biochemical test: As shown in Table 10 of the attached report, the biochemical test revealed no abnormality caused by the administration of HCA. Histopathology:
1) Liver: Pimelosis of the liver and nest like cellular infiltration in the periportal region were observed in several cases, but as they appeared equaly in all groups, they were not considered to have been caused by the administration of HCA.
2) Kidney: Nephritis was observed in all groups (1, 1, 3,2 in groups 1, 2, 3, 4 respectively). However, considering the fact that nephritis in the control group was more severe than in the treated groups, they were not considered to have been caused by the administration of HCA.
3) Heart, lung: One animal with endopericarditis was observed, which was, however, considered to have been caused by pneumonia.
4) Pancreas: Several cases of vacuole were observed, but they were considered to have been produced after the animals’ death.
5) Seminal vesicle and ovary: Abnormality was observed in the seminal vesicle of one male animal of the group 2, but no other abnormality was observed.
6) No significant abnormality was observed in the spleen, marrow stomach, small intestine, large intestine and caecum.
From these results it was concluded that no abnormality caused by HCA was observed pathologically.
Applicant's summary and conclusion
- Conclusions:
- In the rat, dietary intake of 0.24, 0.6 or 1.5% HCA (159, 399 or 1023 mg/kg bw/day in males; 177, 445 or 1094 mg/kg bw/day in females) for 16 weeks showed no evidence of specific target organ toxicity.
- Executive summary:
Groups of 20 rats/sex/group were administered HCA in the diet at 0, 0.24.0.6 or 1.5% for 16 weeks. Body weight and food consumption were measured fortnightly. At termination samples were collected from 10/sex/group for blood and urine clinical chemistry, haematology, organ weight measurement and histopathology.
There were no treatment related effects apart from lower food utilisation efficiency in females at 1.5%. In the absence of any effects on body weight this is considered to be of no toxicological significance.
A dose of 1023 (males) or 1094 (females) mg HCA/kg bw/day for 16 weeks showed no evidence of specific target organ toxicity and was a No Adverse Effect Level (NOAEL).
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