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EC number: 458-680-3 | CAS number: 797751-44-1 WASOX-VMAC2
- 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
Dermal irritation was scored according to OECD guideline nº 404. The treated areas of the animals did not show any sign of erythema/eschar and oedema.
Eye irritations were scored according to OECD guideline nº 405. No ocular lesions were observed at 72 hours.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
An in vitro study does not need to be conducted since adequate data from an in vivo skin irritation study are available. - Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- November 15-26, 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- According to OECD Guideline 404, with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 1.8 – 2.0 kg
- Housing: Individual caging in metal wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days (animal nº 11) and 12 days (animals nº 12 and 13)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 19.2 ºC
- Humidity (%): average of 50.1 ºC
- Photoperiod (hrs dark / hrs light): artificial light from 6 a.m. to 6 p.m. - Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL of the test substance
- Concentration (if solution): the test substance was used undiluted (as it is)
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48, and 72 hours after patch removal
- Number of animals:
- 3 rabbits
- Details on study design:
- TEST SITE
- Area of exposure: 2.5cm x 2.5cm
- Type of wrap if used: a semi-occlusive dressing
SCORING SYSTEM: According to guideline 404 (table: Grading of Skin Reactions)
Erythema / Eschar formation
0 No erythema.
1 Very slight erythema (barely perceptible).
2 Well-defined erythema.
3 Moderate to severe erythema.
4 Severe erythema (beet redness) or eschar formation (injuries in depth).
Oedema formation
0 No oedema.
1 Very slight oedema (barely perceptible).
2 Slight oedema (edges of area well defined by definite raising).
3 Moderate oedema (raised approximately 1 mm).
4 Severe oedema (raised more than 1 mm and extending beyond area of exposure). - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- All areas to be treated with the test substance and all control areas were normal before the application and at each observation time.
- Other effects:
- No relevant findings.
- Interpretation of results:
- other: Not classified as skin irritant (CLP Regulation EC no. 1272/2008)
- Conclusions:
- The treated areas of the animals did not show any sign of erythema/eschar and oedema as well as other local skin alterations.
- Executive summary:
The Acute Dermal Irritation/Corrosion assay for the test substance was performed in New Zealand White rabbits. 0.5 mL of the test material was applied to a site of 2.5cm x 2.5cm, of intact skin of 3 rabbits and covered by semi-occlusive dressing. The administration of the test substance was performed in a sequential manner. The first animal was exposed to the test substance stepwise at three sites of the skin: site 1 for three minutes, site 2 for 1 hour and site 3 for 4 hours. As no serious reactions were noted in the first animal, the remaining two animals were exposed to the test substance one week later for 4 hours. The treated areas of the animals were examined for erythema/eschar and oedema as well as other local skin alterations approximately at 1, 24, 48, and 72 hours after patch removal.
The surrounding of the administration area, i.e. the untreated skin, served as a negative control. Dermal alterations were scored according to OECD guideline nº 404.
The treated areas of the animals did not show any sign of erythema/eschar and oedema.
Referenceopen allclose all
Scores of the application sites
Individual data and means
Time after the end of the exposure |
Erythema / Eschar animal Nos. |
Oedema animal Nos. |
||||
|
11 |
12 |
13 |
11 |
12 |
13 |
1 h |
0 |
0 |
0 |
0 |
0 |
0 |
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
mean (24-72 h) |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
Scores of the application sites of animal No. 11 after exposure for 3 min, 1 h and 4 h
Time after the end of the exposure |
Erythema / Eschar Exposure Time |
Oedema Exposure Time |
||||
|
3 min |
1 h |
4 h |
3 min |
1 h |
4 h |
0 min |
0 |
0 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Justification for type of information:
- JUSTIFICATION FOR DATA WAIVING
An in vitro study does not need to be conducted since adequate data from an in vivo eye irritation study are available. - Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 10-21, 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- According to OECD Guideline 405, with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River
- Weight at study initiation: 2.2 – 2.3 kg
- Housing: Individual caging in metal wire cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days (animal nº 51) and 14 days (animal nº 52 and nº 53)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): average of 19.0 ºC
- Humidity (%): average of 51.7%
- Photoperiod (hrs dark / hrs light): artificial light from 6 a.m. to 6 p.m. - Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.1 mL of test substance
- Duration of treatment / exposure:
- 72 hours (the treated eyes were not washed)
- Observation period (in vivo):
- 1, 24, 48 and 72 hours after the administration of the test substance
- Number of animals or in vitro replicates:
- 3 rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: eye irritations were scored according to guideline 405
CORNEA
Opacity : degree of density (area most dense is taken for reading).
0 No ulceration or opacity.
1 Scattered or diffuse areas of opacity (except for slight dulling of normal lustre),
details of iris clearly visible.
2 Easily discernible translucent area, details of iris slightly obscured.
3 Nacreous area, no details of iris visible, size of pupil barely discernible.
4 Opaque cornea, iris not discernible through the opacity.
IRIS
0 Normal.
1 Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia
or injection; any of these or combination of any thereof, iris still reacting to light (sluggish reaction is positive).
2 No reaction to light, haemorrhage, gross destruction (any of all these or all together).
CONJUNCTIVAE
Redness: (refers to the most severe effect of palpebral and bulbar conjunctivae in comparison to the control eye).
0 Blood vessels normal.
1 Some blood vessels definitely hyperaemic (injected).
2 Diffuse crimson colour, individual vessels not easily discernible.
3 Diffuse beefy red.
Chemosis: lids and/or nictating membranes.
0 No swelling.
1 Any swelling above normal (includes nictating membranes).
2 Obvious swelling with partial eversion of lids.
3 Swelling with lids about half closed.
4 Swelling with lids more than half closed
TOOL USED TO ASSESS SCORE: animals were examined using and otoscope lamp - Irritation parameter:
- cornea opacity score
- Remarks:
- Opacity(degree of density)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: mean scores of animals 51, 52, and 53
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: mean scores of animals 51, 52, and 53
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 51
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: mean
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 52
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: mean
- Irritation parameter:
- conjunctivae score
- Remarks:
- redness
- Basis:
- animal: 53
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: mean
- Irritation parameter:
- chemosis score
- Remarks:
- lids and/or nictating membranes
- Basis:
- animal: 51
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Remarks:
- lids and/or nictating membranes
- Basis:
- animal: 52
- Time point:
- 24/48/72 h
- Score:
- 0
- Reversibility:
- fully reversible within: 72 h
- Irritation parameter:
- chemosis score
- Remarks:
- lids and/or nictating membranes
- Basis:
- animal: 53
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: mean
- Irritant / corrosive response data:
- Reversibility of any observed effect: all changes observed were fully reversible within 3 days
After the instillation of the test substance the following findings were made:
- Corneae and irises were not affected.
- Conjunctivae, redness (a score 1) was noted in all animals from 24 h after application (p.a.) onwards until a maximum of 48 h p.a.
- Conjunctivae, chemosis (a score 1) was observed in 2/3 animals only 1 h (p.a.). A scored of 3, later on decreasing to 1, was noted in 1/3 animals from 1h p.a. onwards until 48 h p.a. - Other effects:
- Ocular discharge was noted in 2/3 animals from 1h onwards until a maximum of 24 h after test substance application.
- Interpretation of results:
- other: Not classified as eye irritant (CLP Regulation EC no. 1272/2008)
- Conclusions:
- No ocular lesions were observed at 72 hours.
- Executive summary:
The Acute Eye Irritation/Corrosion study for the test substance was performed in New Zealand White rabbits. 0.1 mL of the test material was administrated per animal into the conjunctival sacs of the right eyes. The eyes were held closed for about one second to prevent loss of the test substance. The left eyes remained untreated and served as a control. The administration of the test substance was performed in a sequential manner. The first animal was exposed to the test substance, as no evidence for serious damage to the eye of the animal was found during the initial 72 h observation period, the test substance was administrated to the others two animals. Both whole eyes of the animals were examined (especially the corneae, the irises and the conjunctivae) within 24 h before the instillation and approximately 1, 24, 48, and 72 hours after test substance administration. Eye irritations were scored according to OECD guideline nº 405.
No ocular lesions were observed at 72 hours.
Referenceopen allclose all
Scores of the test eyes:
Examination of corneae, irises and
conjunctivae. Individual data and means.*
|
|
|
Conjunctivae |
|||||||||
Time after |
Corneae |
Irises |
Redness |
Chemosis |
||||||||
|
51 |
52 |
53 |
51 |
52 |
53 |
51 |
52 |
53 |
51 |
52 |
53 |
1 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
02) |
03) |
1 |
1 |
3 |
24 h |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
1 |
12) |
0 |
0 |
2 |
48 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
72 h |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
mean |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.0 |
0.3 |
0.3 |
0.7 |
0.0 |
0.0 |
1.0 |
2) Discharge with moistening of the lids and hairs just adjacent to the lids.
3) Discharge with moistening of the lids and considerable area around the eye.
*Dermal alterations were scored according to OECD guideline nº 405.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
The Acute Dermal Irritation/Corrosion assay for the test substance was performed in New Zealand White rabbits. 0.5 mL of the test material was applied to a site of 2.5cm x 2.5cm, of intact skin of 3 rabbits and covered by semi-occlusive dressing. The administration of the test substance was performed in a sequential manner. The first animal was exposed to the test substance stepwise at three sites of the skin: site 1 for three minutes, site 2 for 1 hour and site 3 for 4 hours. As no serious reactions were noted in the first animal, the remaining two animals were exposed to the test substance one week later for 4 hours. The treated areas of the animals were examined for erythema/eschar and oedema as well as other local skin alterations approximately at 1, 24, 48, and 72 hours after patch removal.
The surrounding of the administration area, i.e. the untreated skin, served as a negative control.
The Acute Eye Irritation/Corrosion study for the test substance was performed in New Zealand White rabbits. 0.1 mL of the test material was administrated per animal into the conjunctival sacs of the right eyes. The eyes were held closed for about one second to prevent loss of the test substance.The left eyes remained untreated and served as a control. The administration of the test substance was performed in a sequential manner. The first animal was exposed to the test substance, as no evidence for serious damage to the eye of the animal was found during the initial 72 h observation period, the test substance was administrated to the others two animals. Both whole eyes of the animals were examined (especially the corneae, the irises and the conjunctivae) within 24 h before the instillation and approximately 1, 24, 48, and 72 hours after test substance administration.
Justification for classification or non-classification
Based on the available information, the test item is neither classified as skin corrosion/irritation nor as serious eye damage/eye irritation in accordance with CLP Regulation (EU) No. 1272/2008.
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