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EC number: 915-316-2 | CAS number: -
- 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:
- from 31 May to 24 November 2011
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
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:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reaction mass of 1-phenyloctadecane-1,3-dione and phenylicosane-1,3-dione
- EC Number:
- 915-316-2
- Molecular formula:
- C50H80O4
- IUPAC Name:
- Reaction mass of 1-phenyloctadecane-1,3-dione and phenylicosane-1,3-dione
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 8 weeks
- Weight (mean) at study initiation: 361 g for males and 225 g for females
- Fasting period before study: No
- Housing: The animals were housed by five, from the same sex and group, in polycarbonate cages with stainless steel lids (Tecniplast 2000P, 2065 cm2, 61 cm x 43.5 cm x 21.5 cm). Autoclaved sawdust (SICSA, Alfortville, France) was placed in each cage. Cocoon was given as enrichment
- Diet (ad libitum): SSNIFF R/M-H pelleted diet, batch No. 9945009 (SSNIFF Spezialdiäten GmbH, Soest, Germany)
- Water (ad libitum): tap water (filtered with a 0.22 µm filter)
- Acclimation period: 8 days for males and 5 days for females
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2°C
- Humidity (%): 50 ± 20%
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12h/12h (7:00 - 19:00)
IN-LIFE DATES: From: 31 May to 14 June 2011 for males and from 03 June to 17 June 2011 for females
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
TEST SITE
- Area of exposure: back of the animals
- % coverage: 10% of the total body surface
- Type of wrap if used: The test item was placed on a gauze pad moistened with drinking water treated by reverse osmosis. The gauze pad was held in place with an aerated hypoallergic dressing for 24 hours.
REMOVAL OF TEST SUBSTANCE
- Washing (if done) :After removal of the dressing, any residual test item was removed using a dry cotton pad
- Time after start of exposure: 24 hours.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg body weight (the quantity of test item applied to each animal was adjusted according to the body weight recorded on the day of dose application).
- Concentration (if solution): not applicable
- Constant volume or concentration used: yes
- For solids, paste formed: no- Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals/sex/dose
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each animal was observed after treatment as follows at least once during the first 30 minutes, periodically during the first 4 hours, then once a day, at approximately same time, for the recording of clinical signs. From day 2, any local reactions at the treatment site were also noted. The body weight of each animal was recorded the day of allocation of the animals into groups then on the day of treatment and on days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities).
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No unscheduled deaths occurred during the study.
- Clinical signs:
- other: No clinical signs indicative of systemic toxicity were observed in any animals.
- Gross pathology:
- The few macroscopic findings noted at necropsy consisted of agenesis of the right kidney, testis and epididymis with compensatory enlargement of the left kidney in a single group 2 male (W24093). This developmental anomaly, occasionally recorded in the Sprague-Dawley rats, was unrelated to the test item administration.
- Other findings:
- Very slight erythema was noted in 2/5 females between days 2 and 6. Two other females showed well-defined erythema on days 2 and/or 3 followed by a very slight erythema between days 3 and 4 for one of them and between days 4 and 9 for the second one. For the fifth female, the erythema was moderate to severe between days 2 and 5. The intensity decrease to well-defined on day 6 and it was still noted on day 7. In addition, very slight to slight dryness was noted in 3/5 females between days 3 and 7. Scabs were also noted at the application site of 2/5 females between days 2 and 9.
Very slight erythema was noted on day 2 or 3 in 3/5 males and between days 2 and 4 in 2/5 males. In addition, scabs were noted at the application site for 2 males between days 5 and 6 and between days 3 and 5, respectively.
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 current study, the test item showed no signs of toxicity in female and male rats over a period of 14 days when applied dermally once at 2000 mg/kg bw. The LD50 can therefore be concluded to be greater than 2000 mg/kg bw. Based on this result the reaction mass of Stearoylbenzoylmethane and Palmitoylbenzoylmethane is not classified according to Annex VI of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).
- Executive summary:
RHODIASTAB 55 Phas been tested in an acute dermal toxicity study usingSprague‑Dawley rats, according to OECD guideline n° 402 and EU guideline n° B.3 in compliance with Good Laboratory Practice.
The test item was applied once under semi-occlusive conditions to the clipped back of the animals at a dose level of 2000 mg/kg for 24 h (5 males + 5 females per dose, 10% of the total body surface).
Clinical signs, mortality and body weight gain were checked for a period of up to 14 days after the single administration of Rhodiastab 55P. All animals were subjected to necropsy.
No mortality was recorded in both groups during the study. Body weight gain of the treated animals was not affected by treatment. Local reactions at the application sites consisted in erythema, scab and/or dryness observed in some animals during the first week of the observation period. Local reactions had totally reversed at the end of the observation period. At necropsy, no abnormalities were observed in any animal.
As the LD 50 is higher than 2000 mg/kg, the reaction mass of Stearoylbenzoylmethane and Palmitoylbenzoylmethane is not classified according to Annex VI of the Directive 67/548/CEE and according to EU Regulation 1272/2008 (CLP).
This acute dermal study is classified as acceptable. It satisfies the OECD 402 guideline requirements for an acute dermal study in the rat.
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