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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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 November - 02 December 2005
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study conducted in compliance with OECD guideline 404 with minor deviations: temperature and relative humidity in the animal room sometimes outside the target ranges; systemic effects not followed; individual animal weights not reported
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 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- temperature and relative humidity in the animal room sometimes outside the target ranges; systemic effects not followed; individual animal weights not reported
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- 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
- pH of the test item at the concentration of 10 % in purified water, measured was approximately 6.
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Grimaud frères selection S.A.S., Roussay, France.
- Age at study initiation: 2-4 months
- Weight at study initiation: 2.6 ± 0.1 kg
- Housing: Animals were housed individually in Pajon cages.
- Diet: Control Reference 110 pelleted diet (SAFE, Epinay-sur-Orge, France), ad libitum
- Water: Drinking water filtered by a FG Millipore membrane (0.22 µm), ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3 °C
- Humidity: 30-70 %
- Air changes: Approximately 12 cycles/h of filtered, non-recycled air
- Photoperiod: 12 h dark / 12 h light
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (weight with unit): 500 mg - Duration of treatment / exposure:
- - First animal: 3 minutes, 1 and 4 h
- Other two animals: 4 h - Observation period:
- 72 h
- Number of animals:
- 3 males
- Details on study design:
- TEST SITE
- Area of exposure: Anterior right flank (application for 1 h), anterior left flank (application for 3 minutes) and posterior right flank (application for 4 h).
- Type of wrap if used: Test item in its original form were placed on a gauze pad moistened with purified water and applied to an area of approximately 6 cm2 of the anterior left flank (application for 3 minutes), the anterior right flank (application for 1 h) or the posterior right flank (application for 4 h) of the animals. The gauze pad was held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage.
- Untreated skin served as control.
REMOVAL OF TEST SUBSTANCE
- After removal of the dressing, any residual test item was wiped off by means of a moistened cotton pad.
- Time after start of exposure: 4 h
SCORING SYSTEM: According to OECD Guideline 404
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- - After a 3-minute exposure (one animal), no cutaneous reactions were observed.
- After a 1-h exposure (one animal), no cutaneous reactions were observed.
- After a 4-h exposure (three animals), a very slight erythema (grade 1) was noted in 1/3 animals from Day 1 up to Day 3. - Other effects:
- None
Any other information on results incl. tables
Table 7.3.1/1: Individual skin reactions
Rabbits No. |
Rabbit 747 |
Rabbit 748 |
Rabbit 749 |
|
Erythema |
1 h |
0 |
1 |
0 |
24 h |
0 |
1 |
0 |
|
48 h |
0 |
1 |
0 |
|
72 h |
0 |
0 |
0 |
|
Mean (24, 48 and 72 h) |
0 |
0.7 |
0 |
|
Edema |
1 h |
0 |
0 |
0 |
24 h |
0 |
0 |
0 |
|
48 h |
0 |
0 |
0 |
|
72 h |
0 |
0 |
0 |
|
Mean (24, 48 and 72 h) |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, Mexoryl SBF is not classified as irritating to skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In a primary dermal irritation study performed according to OECD Guideline 404 and in compliance with GLP, three male New Zealand White rabbits were dermally exposed to 500 mg of Mexoryl SBF under a semi-occlusive dressing. The test item was first evaluated on a single animal and the duration of exposure was 3 minutes on the anterior left flank, 1 h on the anterior right flank and 4 h on the posterior right flank. Since the test item was not severely irritant on this first animal, it was then applied for 4 h to two other animals. After removal of the residual test item with moistened cotton pad, irritation was scored as outlined in the OECD Guideline 404 at 1, 24, 48 and 72 h after exposure.
A very slight erythema was noted in 1/3 animals from Day 1 up to Day 3. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 0, 0.7, 0 for erythema and 0, 0, 0 for edema score, respectively. In this study, Mexoryl SBF is not a skin irritant on male rabbits.
Under the test conditions, Mexoryl SBF is not classified as irritating to skin according to the criteria of Annex VI to the Directive 67/548/EEC and 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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