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EC number: 696-026-0 | CAS number: 1395383-69-3
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented pre-guideline study without GLP. Observations can be re-assessed according to present day criteria based on available data
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- A different method has been used to evaluate the study. The Draize score reading is available and therefore data can be translated in the OECD 404-type of evaluation.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-5 (Acute Dermal Irritation)
- Version / remarks:
- FR 43, No., 163, Aug. 22, 1978
- Principles of method if other than guideline:
- The primary irritation index is calculated by summing up erythema and edema scores for the intact and abraded skin and divided by 4.
The exposure period is 24 hours instead of 4 hours
The exposure is both on abraded and non-abraded skin
Observation period is 7 days instead of 14 days after treatment - GLP compliance:
- no
Test material
- Test material form:
- liquid
- Details on test material:
- Batch: 502834
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Ivanovas, 7964 Kissleg/Allgau, germany and Madorin AG, 4114 Fullinsdorf, Switzerland)
- Age at study initiation: adult
- Weight at study initiation: 2-3 kg
- Housing: individual housing in metal cages
- Diet (e.g. ad libitum): Rabbit standard food, NAFAG No. 814 (Nafag, Gossau, Switzerland)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 4 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 2
- Humidity (%): 55 +/- 10
- Air changes (per hr): n/a
- Photoperiod (hrs dark / hrs light): 14/10.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and non-abraded (shaved)
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Patches of 2.5 cm * 2.5 cm loaded with 0.5 ml of the undiluted test material.
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 7 days
- Number of animals:
- 3 males and 3 females
- Details on study design:
- Before the treatment the entire back and the flank of the rabbits were shaved with an electric clipper. Immediately before treatement the shaven skin on one side was scarified (abraded). Gauze patches of 2.5 cm x 2.5 cm loaded with 0.5 ml of the test substance were applied to the abraded and intact skin.
The patches were covered with an impermeable material and were fastened to the body with the rabbit with adhesive tape. The dressings were removed after 24 hour application.
The skin reaction was appraised upon removal and during an observation period of 7 days on the basis of the following evaluation scheme:
Score 0: No erythema
Score 1: Very slight, barely perceptible erythema
Score 2: Well defined erythema
Score 3: Moderate to severe erythema
Score 4: Severe erythema (beet redness) to slight eschar formation
Score 0: No edema
Score 1: Very slight, barely perceptible edema
Score 2: Slight edema, edges of area well defined by definitive raising
Score 3: Moderate edema (raised approximately 1 mm)
Score 4: Severe edema (raised > 1 mm and extending beyond are of exposure)
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- other: mean of six animals
- Time point:
- other: 24 hours
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- other: mean of six animals
- Time point:
- other: 48 hours
- Score:
- 0.8
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- other: mean of six animals
- Time point:
- other: 72 hours
- Score:
- 0.6
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- other: mean of six animals
- Time point:
- other: 4 days
- Score:
- 0.5
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- other: mean of six animals
- Time point:
- other: 7 days
- Score:
- 0.16
- Max. score:
- 1
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- other: mean of six animals
- Time point:
- other: 24 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- other: mean of six animals
- Time point:
- other: 48 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- other: mean of six animals
- Time point:
- other: 72 hours
- Score:
- 0.33
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- other: mean of six animals
- Time point:
- other: 4 days
- Score:
- 0.16
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- other: mean of six animals
- Time point:
- other: 7 days
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 7 days
- Irritant / corrosive response data:
- 24 hours No. 243 No. 244 No. 245 No. 246 No. 247 No. 248
Erythema intact skin 1 0 2 1 1 2
abraded skin 2 1 2 2 2 2
Edema intact skin 0 0 1 0 0 1
abraded skin 0 0 2 0 1 2
48 hours
Erythema intact skin 0 0 2 1 1 1
abraded skin 0 0 2 2 2 2
Edema intact skin 0 0 1 0 0 1
abraded skin 0 0 2 1 1 2
72 hours
Erythema intact skin 0 0 1 1 1 1
abraded skin 0 0 2 2 2 2
Edema intact skin 0 0 1 0 0 1
abraded skin 0 0 2 1 1 2
4 days
Erythema intact skin 0 0 0 1 1 1
abraded skin 0 0 2 2 2 2
Edema intact skin 0 0 0 0 0 1
abraded skin 0 0 2 1 1 2
7 days
Erythema intact skin 0 0 0 1 0 0
abraded skin 0 0 2 2 2 2
Edema intact skin 0 0 0 0 0 0
abraded skin 0 0 2 1 1 2
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: The assessment was performed according to the EEC Guidelines with the scoring from the study.
- Conclusions:
- Based upon the classification criteria (Commission Directive 2001/59/EC of August 2001), the substance is considered to be “not irritating” to rabbit skin.
- Executive summary:
The primary skin irritation potential of the test material was investigated according to guidelines proposed by the US EPA, FR Vol. 43, No. 163, August 22, 1978. The test item was applied by topical occlusive application of 0.5 mL to the intact and abraded skin of each of six young adult New Zealand White rabbits (3 males and 3 females). The duration of treatment was 24 hours. The scoring of skin reactions was performed 24, 48 and 72 hours, as well as 4 and 7 days after removal of the dressing.
The application of the test material to the intact and abraded skin resulted in mild to mederate erythema and edema in all six animals. These effects were reversible on the intact skin and were no longer evident 7 days after treatment, the end of the observation period for all animals, except in one female animal where mild erythema was still present.
Thus, the test item did not induce significant damage to the skin and it can be anticipated that full reversibilty would occur within 14 days on the intact skin.
Therefore, the substance was considered to be slightly irritant under the test condition but does not have to be classified with respect to skin irritation.
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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