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EC number: 456-880-5 | CAS number: 439685-79-7
- 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:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 September - 04 December 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
- Principles of method if other than guideline:
- In this GLP study, a group of 10 guinea pigs (5/sex) applied with the test material (0.05 mL), once daily for 14 days and each animal was observed for mortality, clinical signs, body weight change and irritation scores.
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material: Mexoryl SBB
- Physical state: slightly yellowish liquid
- Lot/batch No.: 0137810
- Date of receipt: 29 August 2008
- Storage condition of test material: Stored at room temperature
- Expiry date: June 2009
Constituent 1
Test animals
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, L'Arbresle, France
- Age at study initiation: 1-2 months
- Weight at study initiation: Males: 355 ± 13 g; females: 363 ± 16 g
- Housing: Housed individually in polycarbonate cages
- Diet: 106 pelleted diet (UAR, Epinay-sur-Orge, France), ad libitum
- Water: Drinking water filtered by a FG Millipore membrane (0.22 μm), ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 50 ± 20 %
- Air changes: Approximately 12 cycles/h of filtered, non-recycled air
- Photoperiod: 12 h dark / 12 h light
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- TEST SITE
- Area of exposure: Right and left flanks; 2 cm X 2 cm
- Time intervals for shavings or clipplings: Application sites were clipped and shaved on Days -1 (a day before the first treatment), 4, 8, 11 and 14, at least 6 h after treatment (4 h during week-end).
- Undiluted test material was applied once daily to the shaved area of left flank of each animal and the test site was not covered by a dressing. Right flank received applications of purified water under the same experimental conditions.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): No rinsing was performed.
TEST MATERIAL
- Amount(s) applied (volume with unit): 0.05 mL
- Constant volume used: Yes
USE OF RESTRAINERS FOR PREVENTING INGESTION: No - Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Not applicable
- Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- Once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Undiluted (0.05 mL)
Basis:
other: per application site (2 cm X 2 cm)
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- None
- Positive control:
- No
Examinations
- Observations and examinations performed and frequency:
- CLINICAL OBSERVATIONS & MORTALITY: Yes
- Time schedule: Daily
BODY WEIGHT: Yes
- Time schedule for examinations: Days -1, 1, 8 and 15
DERMAL IRRITATION (if dermal study): Yes
- Cutaneous reactions were evaluated on both flanks of each animal daily before treatment and on Day 15 according to OECD Guideline 404.
- Daily Irritation Indices (DI) were calculated for both flanks by adding up the obtained values for erythema and edema in all the animals and dividing this total by the number of animals.
- Weekly Mean Irritation Indices (WI) were obtained by calculating the weekly average of the daily indices. - Sacrifice and pathology:
- GROSS PATHOLOGY: No; all the animals were sacrificed by an intraperitoneal injection of sodium pentobarbital and no macroscopic post-mortem examination was performed.
HISTOPATHOLOGY: No; skin samples from both flanks of all animals were fixed in 10 % buffered formalin and no histological examination was performed. - Other examinations:
- None
- Statistics:
- None
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- no effects observed
- Description (incidence and severity):
- minimal skin irritation
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
- No mortality and no clinical signs of toxicity were recorded during the study.
BODY WEIGHT AND WEIGHT GAIN
- Body weight gains of treated animals were similar to expected values for animals of this strain and age.
CUTANEOUS TOLERANCE
- A very slight erythema was observed on Day 3, on the left flank (treated with the test item) of 1/5 females.
- In almost all the animals, a beige coloration of the skin was observed on the left flank (treated with the test item), from Days 3 or 4 until the end of the observation period (Day 15).
- No cutaneous reactions were observed on the control right flank (purified water).
- Maximum Weekly Mean Irritation Index: 0.014 (Week 1) for the flank treated with the test item and 0.00 for the control flank (purified water)
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 100 other: %
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no treatment-related effects on clinical signs; mortality; body weight and cutaneous reactions
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the No Observed Adverse Effect Level (NOAEL) of Mexoryl SBB could be considered as 100 % in Hartley guinea pigs. It is classified as practically non-irritant.
- Executive summary:
In a repeated dose dermal toxicity study conducted in compliance with GLP, a group of 10 Hartley Crl: (HA) BR guinea pigs (5/sex) was dermally exposed to 0.05 mL of undiluted Mexoryl SBB, once a day for 14 days consecutively. Undiluted test material was applied once daily to the shaved area of left flank of each animal and the test site was not covered by a dressing. Right flank (control) received applications of purified water under the same experimental conditions. Examinations during the study included: mortality, clinical observation of animals, body weight change and evaluation of cutaneous tolerance.
No mortality and no clinical signs of toxicity were recorded during the study. Body weight gains of treated animals were similar to expected values for animals of this strain and age. A very slight erythema (grade 1) was observed on Day 3, on the left flank (treated with the test item) of 1/5 females. In almost all the animals, a beige coloration of the skin was observed on the left flank (treated with the test item), from Days 3 or 4 until the end of the observation period (Day 15). No cutaneous reactions were observed on the control right flank (purified water). Maximum Weekly Mean Irritation Indexes were 0.014 (Week 1) for the flank treated with the test item and 0.00 for the control flank (purified water)
Under the test conditions, a No Observed Adverse Effect Level (NOAEL) of Mexoryl SBB was not determined. It is classified as practically non-irritant.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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