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EC number: 680-341-5 | CAS number: 41438-38-4
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation / corrosion, other
- Remarks:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10.09.2002 - 20.12.2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study has been performed under GLP and according to OECD guidelines.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- , 17th July 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC Directive No 92/69/EEC, B.4 (Acute toxicity: Dermal Irritation/Corrosion), 31st July 1992
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS- Source: CEGAV, Saint Mars d'Egrenne, France.- Age at study initiation: 2 - 4 months- Weight at study initiation: 2.7 ± 0.1 kg- Housing: housed individually in polystyrene cages (48.2 cm x 58 cm x 36.5 cm)- Diet (e.g. ad libitum): free access to 110 pelleted diet- Water (e.g. ad libitum): ad libitum- Acclimation period: at least 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18 ± 3- Humidity (%): 30 - 70%- Air changes (per hr): 12- Photoperiod (hrs dark / hrs light): 12/12
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated skin served as control
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 500 mg
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1 hour, 24, 48 and 72 hours after removal of the dressing.
- Number of animals:
- three males
- Details on study design:
- TEST SITE- Area of exposure: right flank- % coverage: - Type of wrap if used: adhesive hypoallergenic aerated semi-occlusive dressingSCORING SYSTEM:Erythema and eschar formation:- no erythema: 0- very slight erythema (barely perceptible): 1- well-defined erythema: 2- moderate to severe erythema: 3- severe erythema (beet redness) to slight eschar formation (injuries in depth): 4Oedema formation- no oedema: 0- very slight oedema (barely perceptible): 1- slight oedema (edges of area well-defined by definite raising): 2- moderate oedema (raised approximately 1 millimetre): 3- severe oedema (raised more than 1 millimetre and extending beyond area of exposure): 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: mean of 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Interpretation of results:
- not classified
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Under this experimental conditions, the test item is non-irritant when applied topically to rabbits.
- Executive summary:
The potential of the test item Mexoryl SBU to induce skin irritation was evaluated in rabbits according to OECD TG 404. The study was conducted in compliance with the principles of GLP.
The test item was applied for 4 hours to three male New Zealand White rabbits. A single dose of 500 mg of the test item first ground to a fine powder was applied to the closely-clipped skin of one flank. The test item was held in contact with the skin by means of a semi-occlusive dressing. Cutaneous reactions were observed approximately 1 hour, 24, 48 and 72 hours after removal of the dressing. The mean values of the scores for erythema and oedema were calculated for each animal.
Except for a very slight erythema noted in 1/3 animal on day 1, no cutaneous reactions were observed during the study. Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and oedema. Under our experimental conditions, the test item is non-irritant when applied topically to rabbits. According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), the test item should not be classified as irritating to the skin.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation, other
- Remarks:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study, according to OECD 405
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: EC 92/69/EEC, B.5, 31st July 1992
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS- Sex: female- Source: CEGAV, Saint Mars d'Egrenne, France- Age at study initiation: 2 to 4 months- Weight at study initiation: 2.9±0.1 kg- Housing: individually- Diet (e.g. ad libitum): ad libitum- Water (e.g. ad libitum): ad libitum- Acclimation period: at least 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 18±3 °C- Humidity (%): 30 to 70- Air changes (per hr): 12 cycles- Photoperiod (hrs dark / hrs light): 12/12
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye, which remained untreated, served as control.
- Amount / concentration applied:
- TEST MATERIAL- Amount(s) applied (volume or weight with unit): 100 mg
- Duration of treatment / exposure:
- 1 single dose, the eyes were not rinsed after administration of the test item.
- Observation period (in vivo):
- 9 days (until complete reversibility)
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE- Washing (if done): noSCORING SYSTEM: Chemosis: 0 to 4, Redness: 0 to 3, Discharge: 0 to 3, Iris lesions 0 to 2, Corneal lesions: 0 to 4, Area of opacity 1 to 4.TOOL USED TO ASSESS SCORE: UV lamp
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- cornea opacity score
- Remarks:
- intensity
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.7
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Remarks:
- chemosis
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 1
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible
- Interpretation of results:
- Category II
- Remarks:
- Migrated informationCriteria used for interpretation of results: EU
- Conclusions:
- Under applied experimental conditions, the test item Mexoryl SBU is irritant when administered by ocular route to rabbits.
- Executive summary:
The potential of the test item Mexoryl SBU to induce ocular irritation was evaluated in three rabbits accoding OECD and EC guidelines. The study was conducted in compliance with the principles of GLP. A single dose of 100 mg of the test item was introduced into the left conjunctival sac. The right not treated eye served as control. The eyes were not rinsed after administration of the test item. Occular reactions were observed approximately 1 hour, 24, 48 and 72 hours after the administration and then daily until reversibility of the ocular reactions. Mean scores calculated for each animal over 24, 48 and 72 hours were 3.0, 1.3 and 2.0 for chemosis, 3.0, 2.0 and 2.0 for redness of the conjuctivae, 1.0, 0.0 and 1.0 for iris lesions and 1.7, 1.7 and 2.0 for corneal opacity.
Rabbit number
Region of eye
Description of ocular reactions
Scores
Mean irritation score
24 h
48 h
72 h
267
Conjuctivae
Chemosis
3
3
3
3.0
Redness
3
3
3
3.0
Iris
1
1
1
1.0
Corneal opacity
Intensity
2
2
1
1.7
268
Conjuctivae
Chemosis
2
1
1
1.3
Redness
2
2
2
2.0
Iris
0
0
0
0.0
Corneal opacity
Intensity
2
2
1
1.7
269
Conjuctivae
Chemosis
2
2
2
2.0
Redness
2
2
2
2.0
Iris
1
1
1
1.0
Corneal opacity
Intensity
2
2
2
2.0
Under applied experimental conditions, the test item Mexoryl SBU is irritant when administered by occular route to rabbits.
Reference
Table 1. Individual ocular examinations and mean values of the scores recorded for each animal (24, 48 and 72 hours)
Rabbit number | Region of eye | Description of ocular reactions | Scores | Mean irritation score(1) | Interpretation (+) (-) | |||
1 h D1 | 2 h D2 | 48 h D3 | 72 h D4 | |||||
267 | Conjunctivae | Chemosis | 3 | 3 | 3 | 3 | 3.0 | (+) |
|
| Redness | 2 | 3 | 3 | 3 | 3.0 | (+) |
|
| Discharge | 2 | 2 | S | S | (2) | (+) |
| Iris |
| 0 | 1 | 1 | 1 | 1.0 | (+) |
| Corneal opacity | Intensity | 0 | 2 | 2 | 1 | 1.7 | (-) |
|
| Area | 0 | 3 | 2 | 1 | 2.0 |
|
| Other |
| * | * | * | * |
|
|
| Fluorescein |
| / | U | U | U |
|
|
268 | Conjunctivae | Chemosis | 3 | 2 | 1 | 1 | 1.3 | (-) |
|
| Redness | 2 | 2 | 2 | 2 | 2.0 | (-) |
|
| Discharge | 2 | 1 | 1 | 0 | 0.7 |
|
| Iris |
| 0 | 0 | 0 | 0 | 0.0 | (-) |
| Corneal opacity | Intensity | 0 | 2 | 2 | 1 | 1.7 | (-) |
|
| Area | 0 | 3 | 2 | 2 | 2.3 |
|
| Other |
| * | * | * | * |
|
|
| Fluorescein |
| / | U | U | U |
|
|
269 | Conjunctivae | Chemosis | 3 | 2 | 2 | 2 | 2.0 | (+) |
|
| Redness | 2 | 2 | 2 | 2 | 2.0 | (-) |
|
| Discharge | 2 | S | S | S | (2) |
|
| Iris |
| 0 | 1 | 1 | 1 | 1.0 | (+) |
| Corneal opacity | Intensity | 0 | 2 | 2 | 2 | 2.0 | (+) |
|
| Area | 0 | 3 | 3 | 3 | 3.0 | (+) |
| Other |
| * | ZB | ZB | ZB |
|
|
| Fluorescein |
| / | U | U | U |
|
|
Table 1 (continued)
Rabbit number | Region of eye | Description of ocular reactions | Scores | ||||
D5 | D6 | D7 | D8 | D9 | |||
267 | Conjunctivae | Chemosis | 2 | 1 | 0 | 0 | 0 |
|
| Redness | 2 | 1 | 1 | 1 | 0 |
|
|
|
|
|
|
|
|
|
| Discharge | 0 | 0 | 0 | 0 | 0 |
| Iris |
| 1 | 0 | 0 | 0 | 0 |
| Corneal opacity | Intensity | 1 | 0 | 0 | 0 | 0 |
|
| Area | 1 | 0 | 0 | 0 | 0 |
| Other |
| * | * | * | * | * |
| Fluorescein |
| U | U | / | / | / |
268 | Conjunctivae | Chemosis | 1 | 1 | 1 | 1 | 0 |
|
| Redness | 2 | 2 | 1 | 1 | 0 |
|
|
|
|
|
|
|
|
|
| Discharge | 0 | 0 | 0 | 0 | 0 |
|
|
|
|
|
|
|
|
| Iris |
| 0 | 0 | 0 | 0 | 0 |
| Corneal opacity | Intensity | 1 | 0 | 0 | 0 | 0 |
|
| Area | 1 | 0 | 0 | 0 | 0 |
| Other |
| * | * | * | * | * |
| Fluorescein |
| U | U | / | / | / |
269 | Conjunctivae | Chemosis | 2 | 1 | 1 | 0 | 0 |
|
| Redness | 2 | 1 | 1 | 1 | 0 |
|
| Discharge | S | 0 | 0 | 0 | 0 |
| Iris |
| 1 | 0 | 0 | 0 | 0 |
| Corneal opacity | Intensity | 1 | 0 | 0 | 0 | 0 |
|
| Area | 1 | 0 | 0 | 0 | 0 |
| Other |
| ZB | * | * | * | * |
| Fluorescein |
| U | U | / | / | / |
D = day; U = Fluorescein batch No. F777; / = Fluorescein not used; * = None; S = Whitish purulent discharge; ZB = White area on the conjunctivae
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The potential of the test item Mexoryl SBU to induce skin irritation was evaluated in rabbits according to OECD TG 404.
Except for a very slight erythema noted in 1/3 animal on day 1, no cutaneous reactions were observed during the study. Mean scores over 24, 48 and 72 hours for each animal were 0.0, 0.0 and 0.0 for erythema and oedema. Under our experimental conditions, the test item is non-irritant when applied topically to rabbits.
The potential of the test item Mexoryl SBU to induce ocular irritation was evaluated in three rabbits accoding OECD and EC guidelines. Mean scores calculated for each animal over 24, 48 and 72 hours were 3.0, 1.3 and 2.0 for chemosis, 3.0, 2.0 and 2.0 for redness of the conjuctivae, 1.0, 0.0 and 1.0 for iris lesions and 1.7, 1.7 and 2.0 for corneal opacity.
Under applied experimental conditions, the test item Mexoryl SBU is irritant when administered by occular route to rabbits.
Justification for selection of skin irritation / corrosion endpoint:
key study
Justification for selection of eye irritation endpoint:
key study
Effects on eye irritation: irritating
Justification for classification or non-classification
According to the Globally Harmonized System of Classification and Labelling of Chemicals and to CLP-Regulation (EC) No. 1272/2008,the test item should not be classified as irritating to the skin and should be classified as irritant for the eye H319.
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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