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EC number: 949-740-4 | 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:
- 07 February - 05 April 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- Its a non-GLP study with deviation from OECD 404.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002
- Deviations:
- yes
- Remarks:
- the temperature and humidity ranges are outside Guideline specifications.
- GLP compliance:
- no
- Remarks:
- The experiment was performed in 2007, therefore pre-dating 1st June 2008 cut off after which GLP compliance is necessary for toxicological tests. The report is dated 2019, because this is when the report itself was finalised.
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 126482-45-2
- Test material form:
- liquid
- Details on test material:
- Storage of test material: in a tightly sealed container, under refrigeration
Informal name: MEL-2
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Kbl:NZW{SPF}
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kitayama Labes Co., Ltd..
- Females (if applicable) nulliparous and non-pregnant: Not stated
- Age at study initiation: 16 - 17 weeks
- Weight at study initiation: 3.37 – 3.82 kg
- Fasting period before study: yes (17 hour)
- Housing: Animals were individually housed in wire mesh cage, 30.5W×49.5D× 33.5H (cm), One animal/cage (during the study).
- Diet (e.g. ad libitum): RC4 (Oriental Yeast, Lot No. 060821)
- Water (e.g. ad libitum): tap water from automated water supply system ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0−27.0°C
- Humidity (%): 35.0−75.0%
- Air changes (per hr): 8 or more times air changes per hour
- Photoperiod (hrs dark / hrs light): 12 : 12
IN-LIFE DATES: 27/2/ 2007 – 9/3/2007
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- 0.5 ml
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1, 24, 48 & 72 hours after patch removal
- Number of animals:
- 3
- Details on study design:
- One side of a 2.45 cm-sq patch (lint, Hasegawamenkou) was applied with 0.5 mL of undiluted test item, the patch was held in place for 4 hrs in the dorsal skin of each animal. The residual test substance was removed from the test side. Observations was made at 1, 24, 48 & 72 hours after patch removal .
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- plus eschar
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other:
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Remarks:
- plus eschar
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: irritant
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Remarks:
- plus eschar
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 1 - <= 2
- Max. score:
- 4
- Reversibility:
- other: Irritant
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: Irritant
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: Irritant
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- other: Irritant
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Remarks:
- plus eschar and edema
- Basis:
- animal #1
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Remarks:
- plus eschar and edema
- Basis:
- animal #2
- Time point:
- other: 1 hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- erythema score
- Remarks:
- plus eschar and edema
- Basis:
- animal #3
- Time point:
- other: 1 Hour
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks on result:
- probability of mild irritation
- Irritant / corrosive response data:
- The substance is not corrosive but was a mild irritant according to the P.D.I.I.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the condition of the study, the primary irritation index (P.D.I.I.) of the test item was 1.4 ('Mild irritant'), following exposure to clipped rabbit skin under semi-occlusive conditions. However, the test item does not meet the criteria for classification according to the Globally Harmonized Classification System or the Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
- Executive summary:
OECD 404 (2019): The irritant or corrosive effects of the test item, was assessed following application to the clipped skin of white New Zealand rabbits. On one side of a 2.45 cm-sq patch (lint, Hasegawamenkou) was applied with 0.5 mL of undiluted test item, the patch was held in place for 4 hrs on the dorsal skin of each animal. The residual test substance was removed from the test side. Observations were made at 1, 24, 48 & 72 hours after patch removal and the skin response scored and the degree of skin irritation was classified according to the categories of Gad and Chengelis method.
Both erythema (score: 1) and edema (score: 1) were observed on 3 tested sites at 1 hour after removal. At 24 hour after patch removal, erythema (score: 2 or 1) was found on 3 test sites, and edema (score 1) was observed on 3 test sites. Erythema (score 1) was found on 3 test sites at 48 and 72 hours after patch removal, however, all of the edema disappeared at 48 hours.
Based on the conditions of this study, the test item was non-corrosive but caused mild irritation to the rabbits' skin according to the categories of skin irritation by Gad and Chengelis method (P.D.I.I. = 1.4). However, under the conditions of the study, it was concluded that the test item does not meet the criteria for classification according to the Globally Harmonized Classification System or Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures.
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