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EC number: 254-384-1 | CAS number: 39255-32-8
- 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
The result of the irritation / corrosion studies is that EMV was not found to be not irritating to skin or eyes.
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:
- 26 August 26 to 09 September 1986
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: - Study performed according to GLP - Study performed according to OECD Guideline 404 (Acute Dermal Irritation / Corrosion) and EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- 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:
- other: New Zealand White albino rabbits
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: obtained from ENKI-Konijnenfarm, Someren, the Netherlands
- Weight at study initiation: 2500-3500 g
- Age at study initiation: Healthy male, young adult
- Housing: The animals were identified by earmarking, and subsequently housed individually in suspended, galvanized cages, fitted with wire-mesh floor and front
- Diet (e.g. ad libitum): A standard laboratory rabbit diet was provided ad libitum.
- Water (e.g. ad libitum): tap water was provided ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): at least 40% (relative humidity)
- Air changes (per hr): ventilation c. 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark cycle - Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.5 ml - Duration of treatment / exposure:
- Exposure period of 4 hours
- Observation period:
- - After an exposure period of 4 hours the patches and the test material applied were removed and the resulting skin reactions were evaluated by the method of Draize et al. (J. Pharmacol. Exp. Ther. 82 (1944) 377-390).
- Further readings were made after 28, 52 and 76 hours, and after 7 and 14 days. - Number of animals:
- 3
- Details on study design:
- Experimental design:
- The procedure was extended with treatment on the abraded skin. After an acclimatization period of six days, i.e. one day prior to the start of the experiment, the hair was removed from the back and flanks of the animals using electric clippers in a way as to avoid abrasions. Three rabbits were treated on the intact skin and on the abraded skin. The abrasions were minor incisions of the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding.
- An amount of 0.5 ml of the undiluted test substance was brought on the intact and the abraded skin under a patch measuring 1 inch x 1 inch. The patches were fixed to the application sites by means of adhesive tape and the entire trunk of each rabbit was wrapped with an impervious material to maintain the test patches in position and to retard evaporation of volatile substances. After an exposure period of 4 hours the patches and the test material applied were removed and the resulting skin reactions were evaluated by the method of Draize et al. (J. Pharmacol. Exp. Ther. 82 (1944) 377-390). A transcript of the grading system by Draize et al. is given in an appendix to this report (see page 11 of attached report).
- Further readings were made after 28, 52 and 76 hours, and after 7 and 14 days. - Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14d
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 14 days
- Remarks on result:
- other: Intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 14d
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.6
- Max. score:
- 1
- Reversibility:
- fully reversible within: 14h
- Remarks on result:
- other: Abraded skin
- Irritant / corrosive response data:
- Skin reaction scoring used the Draize system
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of the results obtained it is concluded that, according to the EEC-standards (as published in the Official Journal of the European Communities, L 257, Volume 26, 16 September 1983), the undiluted test substance Manzanate is not irritating or corrosive to skin.
- Executive summary:
1. A sample of Manzanate was examined undiluted for acute denial irritating/corrosive properties in an experiment with three albino rabbits.
2. The test substance caused very slight or well-defined erythema, very slight or slight scaliness, and very slight oedema in all (three) rabbits.
After 14 days, all skin effects had cleared completely.
3. On the basis of the results obtained it was concluded that, according to the EEC-standards, the undiluted test substance Manzanate is not irritating or corrosive to skin.
Reference
- After 4-76 hours, the skin effects observed in all (three) rabbits generally consisted of very slight or well-defined erythema, and very slight oedema (not after 4 hours). In addition, after 52 hours, all application sites showed very slight scaliness and after 76 hours, slight scaliness.
- After 7 days, well-defined erythema and very slight oedema were still observed in one rabbit (no. 4017), and slight scaliness was still observed in all (three) rabbits.
- After 14 days, all skin effects had cleared completely.
- There were no significant differences between the reactions of the intact skin and those of the abraded skin.
Table 1 - Individual and average irritation scores of Manzanate
Rabbit no. |
Intact skin |
|||
4 hr |
28 hr |
52 hr |
76 hr |
|
A-B |
A-B |
A-B |
A-B |
|
4017 |
2-0 |
2-1 |
2-1 |
2-1 |
4018 |
1-0 |
1-1 |
1-1 |
1-1 |
4028 |
1-0 |
1-1 |
1-0 |
1-0 |
Average |
1.3 |
2.3 |
2.0 |
2.0 |
Rabbit no. |
Abraded skin |
|||
4 hr |
28 hr |
52 hr |
76 hr |
|
A-B |
A-B |
A-B |
A-B |
|
4017 |
2-0 |
2-1 |
2-1 |
2-1 |
4018 |
1-0 |
1-1 |
1-1 |
1-1 |
4028 |
1-0 |
1-1 |
1-1 |
1-0 |
Average |
1.3 |
2.3 |
2.3 |
2.0 |
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:
- 03 September to 05 September 1986.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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:
- other: New Zealand White albino rabbits
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: obtained from ENKI-Konijnenfarm, Someren, the Netherlands
- Age at study initiation: young adult
- Weight at study initiation: body weight range 2500-3500 g
- Housing: The animals were identified by earmarking, and housed individually in suspended, galvanized cages, fitted with wire-mesh floor and front.
- Diet (e.g. ad libitum): A standard laboratory rabbit diet was provided ad libitum.
- Water (e.g. ad libitum): tap water was provided ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): at least 40% (relative humidity)
- Air changes (per hr): ventilation c. 10 air changes/hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark cycle - Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The untreated eye
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 0.1 ml - Duration of treatment / exposure:
- 72 hours
- Observation period (in vivo):
- 1, 24, 48 and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Experimental design:
- Both eyes of each rabbit provisionally selected were examined within 24 hours before testing. Three animals without observable eye effects were used.
- One tenth of a millilitre of the undiluted test substance was allowed to fall on the everted lower lid of one eye of each rabbit. After administration the upper and lower eye lid were carefully closed and subsequently held together for about one second before releasing, to prevent loss of material. The other eye remaining untreated, served as a control. The eyes were not washed out following administration and the animals were released immediately.
- Ocular reactions were judged using the scoring scale which is given in an appendix at the end of this report (see page 10 of attached report).
- Eye effects were examined after one hour, 24, 48 and 72 hours, or until the eye effects had cleared completely. - Irritation parameter:
- cornea opacity score
- Basis:
- animal: 4020
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 4022
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: 4023
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 4020
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 4022
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: 4023
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 4020
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 4022
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: 4023
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48h
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 4020
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 4022
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: 4023
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of the results obtained it is concluded that, according to the EEC-standards (as published in the Official Journal of the European Communities, L 257, Volume 26, 16 September 1984), the undiluted test substance Manzanate is not irritating or corrosive to eyes.
- Executive summary:
1. A sample of Manzanate was examined undiluted for acute eye irritating/corrosive properties in an experiment with three albino rabbits.
2. The test substance caused slight eye effects in all (three) rabbits. After 48 hours, all eye effects had cleared completely.
3. On the basis of the results obtained it was concluded that, according to the EEC-standards, the undiluted test substance Manzanate is not irritating or corrosive to eyes.
Reference
- After one hour and after 24 hours, the eye effects observed in all (three) rabbits consisted of slight redness and slight swelling of the conjunctivae.
- After 48 hours, all eye effect had cleared completely.
Table 1. Individual Scores Awarded to the Ocular Lesions Elicited by Manzanate
Rabbit number |
Cornea opacity |
Iris |
Conjunctivae |
|
Redness |
Chemosis |
|||
|
|
|
After one hour |
|
4020 |
0 |
0 |
1 |
1 |
4022 |
0 |
0 |
1 |
1 |
4023 |
0 |
0 |
1 |
1 |
|
|
|
After 24 hours |
|
4020 |
0 |
0 |
1 |
1 |
4022 |
0 |
0 |
1 |
1 |
4023 |
0 |
0 |
1 |
1 |
|
|
|
After 48 hours |
|
4020 |
0 |
0 |
0 |
0 |
4022 |
0 |
0 |
0 |
0 |
4023 |
0 |
0 |
0 |
0 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
- Skin irritation:
1. A sample of Manzanate was examined undiluted for acute denial irritating/corrosive properties in an experiment with three albino rabbits.
2. The test substance caused very slight or well-defined erythema, very slight or slight scaliness, and very slight oedema in all (three) rabbits.
After 14 days, all skin effects had cleared completely.
3. On the basis of the results obtained it was concluded that, according to the EEC-standards, the undiluted test substance Manzanate is not irritating or corrosive to skin.
- Eye irritation:
1. A sample of Manzanate was examined undiluted for acute eye irritating/corrosive properties in an experiment with three albino rabbits.
2. The test substance caused slight eye effects in all (three) rabbits. After 48 hours, all eye effects had cleared completely.
3. On the basis of the results obtained it was concluded that, according to the EEC-standards, the undiluted test substance Manzanate is not irritating or corrosive to eyes.Justification for selection of skin irritation / corrosion endpoint:
Selected as key study.
Justification for selection of eye irritation endpoint:
Only study available
Justification for classification or non-classification
All studies returned a negative result. Therefore EMV will not be classified as irritating or corrosive.
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