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Diss Factsheets
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EC number: 481-870-2 | CAS number: -
- 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:
- 03 April 2007 and 06 April 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do no effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source:
New Zealand White rabbits were supplied by an accredited supplier.
- Age at study initiation:
Twelve to twenty weeks old.
- Weight at study initiation:
At the start of the study the animals were in the weight range of 2.0 to 3.5 kg.
- Housing:
The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum):
ad libitum (Certified Rabbit Diet)
- Water (e.g. ad libitum)
ad libitum.
- Acclimation period:
At least Five days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C):
17 to 23°C
- Humidity (%):
30 to 70%
- Air changes (per hr):
The rate of air exchange was at least fifteen changes per hour.
- Photoperiod (hrs dark / hrs light):
The lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: clipped
- Vehicle:
- water
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit):0.5 g
- Concentration (if solution): Not applicable.
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5g of test material was moistened with 0.5 ml of distilled water.
- Concentration (if solution):Not applicable.
- Lot/batch no. (if required): Not applicable. - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: On the day of the test a suitable test site was selected on the back of each rabbit.
- % coverage:Not available
- Type of wrap if used: Test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours.
SCORING SYSTEM: Approximately one hour following the removal of the patches, and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the following scale (table below).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Erythema/Eschar Formation
- Basis:
- animal: 66107 male
- Time point:
- other: Mean score at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No evidence of skin irritation
- Irritation parameter:
- other: Erythema/Eschar Formation
- Basis:
- animal: 66108 Male
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No evidence of skin irritation
- Irritation parameter:
- other: Erythema/Eschar Formation
- Basis:
- animal: 66110 male
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No evidence of skin irritation
- Irritation parameter:
- other: Oedema Formation
- Basis:
- animal: 66107 male
- Time point:
- other: mean of 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No evidence of skin irritation
- Irritation parameter:
- other: Oedema Formation
- Basis:
- animal: 66108 male
- Time point:
- other: mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No evidence of skin irritation
- Irritation parameter:
- other: Oedema Formation
- Basis:
- animal: 66110 male
- Time point:
- other: Mean at 24, 48 and 72 hours
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- other: No evidence of skin irritation
- Irritant / corrosive response data:
- The individual scores for erythema/eschar and oedema are given in remarks on results including tables and figures.
No evidence of skin irritation was noted during the study. - Other effects:
- Red-coloured staining was noted at all treated skin sites throughout the study. This did not affect evaluation of skin reactions.
Any other information on results incl. tables
The individual scores for erythema/eschar and oedema are given in Table1.
Table1 IndividualSkin Reactions
Skin Reaction |
Observation Time |
Individual Scores – Rabbit Number and Sex |
Total |
||
66107 Male |
66108 Male |
66110 Male |
|||
Erythema/Eschar Formation |
1 Hour |
0STA |
0 STA |
0 STA |
(0 ) |
24 Hours |
0 STA |
0 STA |
0 STA |
0 |
|
48 Hours |
0 STA |
0 STA |
0 STA |
( 0 ) |
|
72 Hours |
0 STA |
0 STA |
0 STA |
0 |
|
Oedema Formation |
1 Hour |
0 |
0 |
0 |
( 0 ) |
24 Hours |
0 |
0 |
0 |
0 |
|
48 Hours |
0 |
0 |
0 |
( 0 ) |
|
72 Hours |
0 |
0 |
0 |
0 |
|
Sum of 24 and 72-hour Readings (S): 0 |
|||||
Primary Irritation Index (S/6) : 0/6 = 0.0 |
|||||
Classification : NON-IRRITANT |
STA= Red-coloured staining
( ) = Total values not used for calculation of primary irritation index
The test material produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a primary irritation index of 0.0 and was classified as non irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
- Executive summary:
- The study was performed to assess the irritancy potential of the
test material to the skin of the New Zealand White rabbit. The method was
designed to meet the requirements of the following:
§ OECD Guidelines for the Testing of Chemicals No. 404 “Acute Dermal Irritation/Corrosion” (adopted)
§ Method B4 Acute Toxicity (Skin Irritation) of Commission Directive 2004/73/EC
A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced no evidence of skin irritation.
The test material produced a primary irritation index of 0.0 and was classified as non‑irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
The test material did not meet the criteria for classification as irritant according to EU labelling regulations Commission Directive 2001/59/EC.
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