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Diss Factsheets
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EC number: 643-080-8 | CAS number: 24389-25-1
- 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
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Endpoint summary
Administrative data
Description of key information
In an GLP-compliant, in vivo skin irritation study conducted in accordance with OECD guideline, corrosive effects were seen in one animal in this study. The effects were irreversible after 14 days.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- other: Japanese White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Kitayama LABES Co., Ltd
- Age at study initiation: 11 weeks old
- Weight at study initiation: 2.51 - 2.64 kg
- Housing: Hanging type aluminium cages (32W x 48D x 33H cm, stainless steel mesh flooring)
- Diet (e.g. ad libitum): Pellet diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: 1 day after 7 day quarantine period
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9 - 24.1°C
- Humidity (%): 45.1 - 63.0 %
- Air changes (per hr): 6 - 20
- Photoperiod (hrs dark / hrs light): 12h dark, 12h light
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- other: olive oil
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g test substance
VEHICLE
- Amount(s) applied (volume or weight with unit): 0.15 mL
- Lot/batch no. (if required): 70910 - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 14 days
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: dorsal area of the trunk
- coverage: approx 6cm2
- Type of wrap if used: semi-occlusive elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours
OBSERVATION TIME POINTS
1, 24, 48, 72 hours then 7, 10, 14 days
SCORING SYSTEM:
- Method of calculation: following the OECD guideline - Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- not reversible
- Remarks:
- eschar formation was observed after 7 days and did not reverse by the end of the 14 day observation period
- Remarks on result:
- probability of severe irritation
- Remarks:
- Max score achieved on Day 7, 10 and 14 observations
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other:
- Remarks:
- no effect
- Other effects:
- - Other adverse local effects: Irreversible effects to the skin was observed in one animal during the study
- Interpretation of results:
- Category 1 (corrosive) based on GHS criteria
- Conclusions:
- The substance is concluded to be corrosive/severly irritating to skin and therefore a classification of Skin Corrosion Category 1 is applied.
Reference
No irritation was seen in the control animals (treated with olive oil) all scores zero.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
- Reason / purpose for cross-reference:
- data waiving: supporting information
- Reason / purpose for cross-reference:
- data waiving: supporting information
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the result of the in vivo skin irritation test where one animal showed evidence of irreversible corrosive effects and the local corrosive effects seen in the acute dermal study, this substance is classified as Skin Corrosion 1 (H314) in accordance with the CLP Regulation (EC 1272/2008, as amended). Data are not available to subcategorise the classification of this substance for this endpoint. Although no study is available to assess eye irritation; the substance is classified as corrosive to skin and therefore the classification of Eye damage 1 (H318) is automatically assigned in accordance with the CLP Regulation (EC 1272/2008).
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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