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EC number: 417-790-1 | CAS number: 78418-01-6
- 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
Endpoint summary
Administrative data
Description of key information
No signs of irritation were observed in a skin irritation study in rabbits.
Irreversible eye damages were observed in rabbits.
Moreover Mexoryl SAB is a powder and contains from 13.23% to 26.71% of inhalable particles (i.e. diameter < 100 µm). Therefore a potential exposure of the worker cannot be excluded. However, due to the low acute toxicity by dermal and oral routes, it is considered that the only potential effects by inhalation may be local effects. Therefore, it is classified by default as R37 "Irritating to respiratory system" according to Directive 67/548/EC and H335 "May cause respiratory irritation" according to CLP Regulation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 october 1989 to 14 october 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study following OECD and EU guidelines, with minor deviations: no certificate of analysis and housing temperature
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No certificate of analysis, deviation in housing temperature
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: David Percival Ltd, Moston, U.K.
- Age at study initiation: approximately 12 weeks to 16 weeks old
- Weight at study initiation: 2.12 - 2.30 kg
- Housing: individually housed in suspended metal cages
- Diet (e.g. ad libitum): rabbit diet (Preston Farmers limited, New Leake, U.K.), ad libitum
- Water (e.g. ad libitum): normal drinking water, ad libitum
- Acclimation period: after a minimum acclimatisation period of 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16-20
- Humidity (%): 62-65
- Air changes (per hr): approximately 15 changes/h
- Photoperiod (hrs dark / hrs light): 12 h light and 12 h dark
IN-LIFE DATES: From: 11 October 1989 To 14 October 1989 - Type of coverage:
- other: elasticated corset
- Preparation of test site:
- other: clipped dorsal and flank area
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with 0.5 mL of distilled water
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: 2.5 cm x 2.5 cm gauze patch secured with a strip of surgical adhesive tape. The trunk was wrapped in an elasticated corset (Tubigrip)
REMOVAL OF TEST SUBSTANCE
- Gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 4 h
SCORING SYSTEM: Draize J. H. scale (1959) - Irritation parameter:
- overall irritation score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- overall irritation score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- overall irritation score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritant / corrosive response data:
- No irritation
- Other effects:
- No data
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was regarded as not irritating 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 GLP study performed according to OECD guideline 404, three young adult male White New-Zealand rabbits were dermally exposed to 0.5 g of ER 195 in 0.5 mL of distilled water for 4 hours to 6.25 cm² of clipped skin. Animals then were observed for 3 days. Irritation was scored by the method of Draize (1959).
There was no irritant effect at any observation time point. In this study, ER 195 is not a dermal irritant on male rabbits.
Under the test conditions, ER 195 is not classified as irritating to the skin according to the criteria of Annex VI to the Directive 67/548/EEC and CLP Regulation (EC) N° (1272-2008).
Reference
No data
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 October 1989 - 8 November 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP study following OECD guideline 405 with minor deviations: no certificate of analysis and low housing temperature conditions
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- No certificate of analysis and low housing temperature
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: David percival Ltd, Moston, U.K.
- Age at study initiation: between 12 and 16 weeks
- Weight at study initiation: 2.31 - 2.92 kg
- Housing: individually housed in metal cages
- Diet (e.g. ad libitum): rabbit diet (Preston Farmers limited, New Leake, U.K.), ad libitum
- Water (e.g. ad libitum): normal drinking water, ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 15-19
- Humidity (%): 50-65
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
IN-LIFE DATES: From: 23 October 1989 To: 8 November 1989 - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approximately 65 mg - Duration of treatment / exposure:
- Eye was not washed after exposure
- Observation period (in vivo):
- 14 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
- Time after start of exposure: no removal of substance
SCORING SYSTEM: by Kay J.H. and Calandra J.C., 1962
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein - Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48,72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- other: the animal was killed after 72 h observation
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks:
- animal killed after 72 h observation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.3
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks:
- animal killed after 72 h observation
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 days
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 2.7
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean individual score
- Time point:
- other: 24, 48, 72 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks:
- animal killed after 72 h observation
- Irritant / corrosive response data:
- Diffuse corneal opacity, iridial inflammation and moderate or severe conjunctival irritation were noted in all treated eyes one hour after treatment and
in two treated eyes at subsequent 24, 48 and 72-hour observations.
In one animal, the corneal opacity in the treated eye increased and areas of opalescent corneal opacity with iridial inflammation and moderate to severe conjunctival irritation were noted in this treated eye at the 48 and 72-hour observation. Other adverse effects noted on the nictitating and/or conjunctival membranes of this treated eye were pale appearance, small green-coloured or white areas and areas of haemorrhage. A blood stained discharge was also noted. For humane reasons this animal was killed after the 72-hour observation.
In another animal, diffuse corneal opacity, iridial inflammation and minimal conjunctival irritation persisted in the treated eye on day seven. No corneal opacity, iridial inflammation or conjunctival irritation was noted on day fourteen. Circumcorneal vascularisation and convoluted eyelids were also apparent during this period. The nictitating membrane was also pale in appearance.
The corneal opacity in the eye of the third treated animal increased and opalescent corneal opacity with pannus formation, indicative of irreversible ocular damage, had developed on day fourteen. The iridial inflammation could not be assessed at this time; minimal conjunctival irritation with convoluted eyelids were also noted. For humane reasons this animal was killed on day fourteen. - Other effects:
- No data
- Interpretation of results:
- highly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material ER 195, was found to be at least severe irritant to the rabbit eye and should be classified R41 according to the criteria of Annex VI to the Directive 67/548/EEC and category 1 according to CLP Regulation (EC) N° (1272-2008).
- Executive summary:
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, 3 healthy (two males and one female) adult rabbits of the New Zealand White strain were exposed to 65 mg of undiluted ER 195 in their right eye while the other eye corresponded to the control. The eyes were examined unwashed and the changes were observed at 24, 48 and 72 h after dosing and graded according to Kay J. H. and Calandra J. C. (1962).
Diffuse corneal opacity, iridial inflammation and moderate or severe conjunctival irritation were noted in all treated eyes one hour after treatment and in two treated eyes at subsequent 24, 48 and 72-hour observations.
In one animal, the corneal opacity in the treated eye increased and areas of opalescent corneal opacity with iridial inflammation and moderate to severe conjunctival irritation were noted in this treated eye at the 48 and 72-hour observation. Other adverse effects noted on the nictitating and/or conjunctival membranes of this treated eye were pale appearance, small green-coloured or white areas and areas of haemorrhage. A blood stained discharge was also noted. For humane reasons this animal was killed after the 72-hour observation.
In another animal, diffuse corneal opacity, iridial inflammation and minimal conjunctival irritation persisted in the treated eye on day seven. No corneal opacity, iridial inflammation or conjunctival irritation was noted on day fourteen. Circumcorneal vascularisation and convoluted eyelids were also apparent during this period. The nictitating membrane was also pale in appearance.
The corneal opacity in the eye of the third treated animal increased and opalescent corneal opacity with pannus formation, indicative of irreversible ocular damage, had developed on day fourteen. The iridial inflammation could not be assessed at this time; minimal conjunctival irritation with convoluted eyelids were also noted. For humane reasons this animal was killed on day fourteen.
Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 1, 1, 2.7 for cornea score, 1, 1, 1 for iris score, 2.7, 2.7, 2.3 for conjunctivae score and 2.7, 2.7, 3 for chemosis score.
Under these test conditions, ER 195, was found to be at least severe irritant to the rabbit eye and should be classified R41 according to the criteria of Annex VI to the Directive 67/548/EEC and category 1 according to CLP Regulation (EC) N° (1272-2008).
Reference
Individual and mean scores for cornea, iris and conjunctivae
Rabbit number & sex |
Time after treatment |
Corneal opacity |
Iridial inflammation |
Conjunctival redness |
Conjunctival chemosis |
||||||||
178 male |
24 h |
1 |
1 |
2 |
3 |
||||||||
|
48 h |
1 |
1 |
3 |
3 |
||||||||
|
72 h |
1 |
1 |
3 |
2 |
||||||||
Total |
|
3 |
3 |
8 |
8 |
||||||||
Mean |
|
1.0 |
1.0+ |
2.7+ |
2.7+ |
||||||||
156 male |
24 h |
1 |
1 |
2 |
2 |
||||||||
|
48 h |
1 |
1 |
3 |
3 |
||||||||
|
72 h |
1 |
1 |
3 |
3 |
||||||||
Total |
|
3 |
3 |
8 |
8 |
||||||||
Mean |
|
1.0 |
1.0+ |
2.7+ |
2.7+ |
||||||||
162 female |
24 h |
2 |
1 |
2 |
3 |
||||||||
|
48 h |
3 |
1 |
2 |
3 |
||||||||
|
72 h |
3 |
1 |
3 |
3 |
||||||||
Total | 8 | 3 | 7 | 9 | |||||||||
Mean | 2.7+ | 1.0+ | 2.3 | 3.0+ |
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In a primary dermal irritation GLP study performed according to OECD guideline 404, there was no irritant effect at any observation time point.
In an eye irritation study conducted according to the OECD Guideline 405 and in compliance with GLP, irreversible ocular damages were observed. Mean individual scores at 24, 48 and 72 h after exposure for the 3 animals were 1, 1, 2.7 for cornea score, 1, 1, 1 for iris score, 2.7, 2.7, 2.3 for conjunctivae score and 2.7, 2.7, 3 for chemosis score.
Effects on eye irritation: highly irritating
Effects on respiratory irritation: irritating
Justification for classification or non-classification
As no irritant effect was observed during a dermal irritation study performed in rabbits according to OECD guideline 404 and GLP conditions, Mexoryl SAB is not classified for skin irritation according to the Regulation (EC) No. 1272/2008 (CLP) and the Directive 67/548/EEC.
As irreversible eye damages were observed in an eye irritation study conducted in rabbits according to the OECD Guideline 405 and in compliance with GLP, Mexoryl SAB is classified R41 "Risk of serious damage to eyes" according to the Directive 67/548/EC and category 1 with risk phrase H318 "Causes serious eye damage" according to CLP Regulation (EC) N° (1272-2008).
Meroxyl SAB is a powder containing about 13% of particles < 100 µm therefore a potential exposure by inhalation cannot be excluded. Due to the potential exposure by inhalation and the irritating properties of Mexoryl SAB to the eyes, it is classified by default as R37 "Irritating to respiratory system" according to Directive 67/548/EC and H335 "May cause respiratory irritation" according to CLP Regulation.
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