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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 November - 14 December 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in compliance with OECD Guideline 423 with minor deviation: relative humidity in the animal room was sometimes outside of the target range
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:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- relative humidity in the animal room was sometimes outside of the target range
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material: Mexoryl SBF
- Physical state: Thick brownish paste (very sticky)
- Analytical purity: 92 %
- Lot/batch No.: 003D001
- Date of receipt: 18 November 2005
- Expiration date of the lot/batch: October 2006
- Storage condition of test material: Stored at +4 °C and protected from light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Approximately 8 weeks
- Weight at study initiation: 197 ± 9 g
- Fasting period before study: Animals were fasted for an overnight period of approximately 18 h before dosing, but had free access to water. Food was given back approximately 4 h after administration of the test item.
- Housing: Animals were housed in polycarbonate cages with stainless steel lid. Each cage contained 1-7 animals during the acclimation period and 3 rats of the same group during the treatment period.
- Diet: Adapted pelleted diet SsniffR/M-H (SSNIFF Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: Drinking water filtered by a FG Millipore membrane (0.22 µm), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 30-70 %
- Air changes: Approximately 12 cycles/h of filtered, non-recycled air
- Photoperiod: 12 h dark / 12 h light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: purified water
- Details on oral exposure:
- MAXIMUM DOSE VOLUME ADMINISTERED: 10 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: Dose-level used as the starting dose-level was selected from one of four fixed levels 5, 50, 300 or 2000 mg/kg bw. As the information on the toxic potential of the test item suggested that mortality was unlikely at the highest dose-level, a limit test was performed, using the starting dose-level of 2000 mg/kg bw with three animals. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- - First assay: 3 females
- Confirmatory assay: 3 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical signs and mortality: Animals were observed frequently during the hours following administration of the test item, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day.
Bodyweight was recorded on Days 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: Yes; On Day 15, all animals were killed by carbon dioxide asphyxiation and were subjected to a macroscopic examination. - Statistics:
- None
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- - No mortality was observed.
- Clinical signs:
- other: - Piloerection was observed within 2 h of treatment in 3/6 animals. No other clinical signs were noted.
- Gross pathology:
- - No macroscopic abnormalities were observed at necropsy.
- Other findings:
- None
Any other information on results incl. tables
Table 7.2.1/1: Individual and mean body weight and weekly body weight change of treated rats (g)
Sex/Dose |
Animal no. |
Days |
||||
1 |
(1) |
8 |
(1) |
15 |
||
First assay: Female/2000 mg/kg bw |
1 |
182 |
-13 |
169 |
66 |
235 |
2 |
203 |
1 |
204 |
32 |
236 |
|
3 |
195 |
0 |
195 |
33 |
228 |
|
Mean |
193 |
-4 |
189 |
44 |
233 |
|
SD |
11 |
8 |
18 |
19 |
4 |
|
Confirmatory assay: Female/2000 mg/kg bw |
4 |
193 |
43 |
236 |
13 |
249 |
5 |
203 |
42 |
245 |
18 |
263 |
|
6 |
204 |
37 |
241 |
23 |
264 |
|
Mean |
200 |
41 |
241 |
18 |
259 |
|
SD |
6 |
3 |
5 |
5 |
8 |
(1) = body weight gain; M = mean; SD = standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the oral LD50 for Mexoryl SBF is higher than 2000 mg/kg bw in female rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In an acute oral toxicity study (limit test) performed according to OECD Guideline 423 and in compliance with GLP, groups (6 female rats/dose) of Sprague Dawley [Rj: SD (IOPS Han)] rats were given a single oral (gavage) dose of Mexoryl SBF at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days and were all sacrificed for macroscopic examination. Before the confirmatory test, a sighting test was conducted at the dose-level of 2000 mg/kg bw and animals were observed for 14 days.
No mortality was observed. Piloerection was observed within 2 h of treatment in 3/6 animals. No other clinical signs were noted. During the first week of the study, a reduced body weight gain and a body weight loss were observed in 2/6 and 1/6 animals, respectively, without any relevant consequence at the end of the study. The overall body weight gain of the other treated animals was not affected by treatment with the test item. No macroscopic abnormalities were observed at study termination on Day 15. In this study, the oral LD50 of Mexoryl SBF was considered to be higher than 2000 mg/kg bw in female rats.
Under the test conditions, the oral LD50 for Mexoryl SBF is higher than 2000 mg/kg bw in female rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008).
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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