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EC number: 228-250-8 | CAS number: 6197-30-4
- 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: dermal
Administrative data
- Endpoint:
- sub-chronic toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Reference
- Endpoint:
- toxicity to reproduction
- Remarks:
- other: subchronic dermal toxicity study
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study.
- Reason / purpose for cross-reference:
- reference to same study
- Principles of method if other than guideline:
- Percutaneous 91 day subchronic toxicity study.
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- for details see chapter 7.5.2
- Route of administration:
- dermal
- Vehicle:
- other: Mixture of petrolatum and C12-15 alkylbenzoate (Finsolv TN) at differing ratios
- Details on exposure:
- for details see chapter 7.5.2
- Details on mating procedure:
- not applicable
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 91 days
- Frequency of treatment:
- 5 days per week, totally 65 applications
- Details on study schedule:
- for details see chapter 7.5.2
- Remarks:
- Doses / Concentrations:
130, 264, 534 mg/kg/day
Basis:
other: nominal per unit body weight - No. of animals per sex per dose:
- 5 males and 5 females per group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- for details see chapter 7.5.2
- Positive control:
- no
- Parental animals: Observations and examinations:
- for details see chapter 7.5.2
- Oestrous cyclicity (parental animals):
- not performed
- Sperm parameters (parental animals):
- Parameters examined :
epididymal sperm motility, concentration and morphology - Litter observations:
- not performed
- Postmortem examinations (parental animals):
- histopathological evaluations of testes and epididymides
for further details see chapter 7.5.2 - Postmortem examinations (offspring):
- not performed
- Statistics:
- for details see chapter 7.5.2
- Reproductive indices:
- not performed
- Offspring viability indices:
- not performed
- Reproductive effects observed:
- not specified
Regardless of sex or applied concentration, none of the Octocrylene-treated rabbits showed any evidence of macroscopic or histopathological abnormalities in any organs examined.
In male rabbits, morphological examination of epididymis and testicles showed no signs of Octocrylene-associated abnormalities.
OTHER EXAMINATIONS
Epididymal sperm concentrations were (mean ± SD ; n= 5; sperm/g caudal tissue):
311 ± 57 (control),
380 ± 211 (130 mg/kg/day)
467 ± 301 (264 mg/kg/day)
245 ± 58 (534 mg/kg/day).
Percentage sperm motility in these same groups was (mean ± SD; n= 5):
92 ± 4 (control)
91 ± 5 (130 mg/kg/day)
88 ± 8 (264 mg/kg/day)
86 ± 6 (534 mg/kg/day)
for further details see chapter 7.5.2
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Evaluation of Subchronic (13 Week), Reproductive, and in Vitro Genetic Toxicity Potential of 2-Ethylhexyl-2-cyano-3,3-diphenyl Acrylate (Octocrylene).
- Author:
- Odio RM et al.
- Year:
- 1 994
- Bibliographic source:
- Fund Appl Toxicol 22: 355-368.
- Reference Type:
- publication
- Title:
- Toxicological Profile of 2-ethylhexyl-2-cyano-3,3-diphenylacrylate (Octocrylene).
- Author:
- Odio MR et al
- Year:
- 1 992
- Bibliographic source:
- Toxicologist 12 (1): 96, abstract no 396.
Materials and methods
- Principles of method if other than guideline:
- Percutaneous 91 day subchronic toxicity study
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Octocrilene
- EC Number:
- 228-250-8
- EC Name:
- Octocrilene
- Cas Number:
- 6197-30-4
- Molecular formula:
- C24H27NO2
- IUPAC Name:
- 2-ethylhexyl 2-cyano-3,3-diphenylacrylate
- Details on test material:
- - Name of test material (as cited in study report): Octocrylene, supplier: BASF
No further data
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
male and female New Zealand White rabbits
- Source: Hazelton Research Products, Denver, PA
- Age at study initiation: no data
- Weight at study initiation: 2.0 to 2.3 kg
- Fasting period before study: no
- Housing: individually in suspended stain less-steel cages
- Diet: Purina No. 5325, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: no data
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- other: mixture of petrolatum and C12-15 alkylbenzoate (Finsolv TN) at differing ratios
- Details on exposure:
- TEST SITE
- Area of exposure: back
- % coverage: open
- Time intervals for shavings or clippings: as needed, no further details
REMOVAL OF TEST SUBSTANCE
- Washing (if done): daily with tepid water
- Time after start of exposure: 7 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg bw
- Concentration (if solution): 7.5, 15, 30 % (w/w)
- Constant volume or concentration used: yes
VEHICLE
mixture of petrolatum and C12-15 alkylbenzoate (Finsolv TN) at differing ratios
- Justification for use and choice of vehicle (if other than water): no data
- Amount(s) applied (volume or weight with unit): 2 ml/kg bw
- Lot/batch no. (if required): no data
- Purity: no data
USE OF RESTRAINERS FOR PREVENTING INGESTION: yes
To prevent ingestion a restraining collar was placed around the neck of each animal before application. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 91 days
- Frequency of treatment:
- 5 days per week, totally 65 applications
Doses / concentrations
- Remarks:
- Doses / Concentrations:
130, 264, 534 mg/kg/day
Basis:
nominal per unit body weight
- No. of animals per sex per dose:
- 5 males and 5 females per group
- Control animals:
- yes, concurrent vehicle
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
DERMAL IRRITATION (if dermal study): Yes
- Time schedule for examinations: daily
The skin at the site of compound application was examined in each animal for the presence of erythema, edema, desquamation, atonia, fissuring, eschar, and exfoliation.
BODY WEIGHT: Yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION: No data
FOOD EFFICIENCY: No
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: within 3 days after the last dose
- Anaesthetic used for blood collection: Yes (sodium pentobarbital)
- Animals fasted: No data
- How many animals: all animals
- Parameters examined:
erythrocyte count, leukocyte count, platelet count, differential leukocyte count, cell morphology, hematocrit, hemoglobin concentration, mean corpuscular volume, mean corpuscular hemoglobin concentration
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- Within 3 days after the last dose, animals were terminated by exsanguination under pentobarbital anesthesia.
GROSS PATHOLOGY: Yes
examination of external surfaces and all internal organs
determination of liver and kidney weight
HISTOPATHOLOGY: Yes
All internal organs and samples of the treated skin areas were preserved in 10 % neutral buffered formalin. Preserved tissues were trimmed, embedded in paraffin, sectioned, stained with hematoxylin and eosin, and examined microscopically. To evaluate Octocrylene effects on male reproductive status, histopathological evaluations of testicles and epididymis were conducted. In addition, epididymal sperm motility, concentration, and morphology were examined. - Statistics:
- Bartlett's Test
ANOVA
Dunnett's Test
Wilcoxon-Mann-Whitney test
analysis of covariance
Cochran-Armitage Test
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No clinical signs were observed, with exception of local findings at the application area (see below). All animals survived until scheduled sacrifice.
SKIN IRRITATION
Octocrylene-treated rabbits presented dose-dependent hindlimb alopecia and skin irritation at the site of compound application. Macroscopically, the predominant dermal effects were erythema and desquamation in all dose groups. Edema and fissuring were observed sporadically, but these events were not consistent or prevalent enough to merit further discussion. Eschar and exfoliation were not observed.
In terms of histopathological effects, Octocrylene-treated rabbits showed consistently greater incidence of skin abnormalities than control counterparts. In this instance, a dose-related pattern was less evident than that noted for macroscopical observations, but this could reflect the all-or-nothing nature of the observation, which did not incorporate a quantitative evaluation of severity.
BODY WEIGHT AND WEIGHT GAIN
In both sexes, mid- and high-dose treatments significantly depressed body weight gain relative to the corresponding controls. At the low dose, no significant body weight effect was noted in females (NOEL = 130 mg/kg bw), whereas in male animals, a statistically significant depression of body weight gain was still observed (NOEL not established). The ratio of final to initial weights shows a pattern similar to that noted for skin irritation effects. The magnitude of the irritant or body weight effects was generally comparable for males and females treated with 264 and 534 mg/kg/day Octocrylene. By contrast, both the weight and the irritation effects were of lesser magnitudes for males and females treated with the low dose of the compound
HAEMATOLOGY
Clinical hematology values were within historical control limits for this strain of rabbit.
ORGAN WEIGHTS
No significant effects in kidney weights of male or female rabbits at any of the Octocrylene doses tested.
GROSS PATHOLOGY and HISTOPATHOLOGY
Regardless of sex or applied concentration, none of the Octocrylene-treated rabbits showed any evidence of macroscopic or histopathological abnormalities in any organs examined.
In male rabbits, morphological examination of epididymis and testicles showed no signs of Octocrylene-associated abnormalities.
OTHER EXAMINATIONS
Epididymal sperm concentrations were (mean ± SD ; n= 5; sperm/g caudal tissue):
311 ± 57 (control),
380 ± 211 (130 mg/kg/day)
467 ± 301 (264 mg/kg/day)
245 ± 58 (534 mg/kg/day).
Percentage sperm motility in these same groups was (mean ± SD; n= 5):
92 ± 4 (control)
91 ± 5 (130 mg/kg/day)
88 ± 8 (264 mg/kg/day)
86 ± 6 (534 mg/kg/day)
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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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