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EC number: 269-304-0 | CAS number: 68214-62-0
- 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
- Remarks:
- source of read across
- Adequacy of study:
- key study
- Study period:
- From May 26 to August 15, 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Similar Substance 03
- IUPAC Name:
- Similar Substance 03
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Association of Breeders of Hradec Kralove.
- Weight at study initiation: above 2.5 kg.
- Housing: the rabbits were house invidually in metal cages commercially produced without bedding, with automatic air-condition.
- Diet: rabbits were fed standard commercially manufacturing feed mixture TM-rabbit, ad libitum.
- Water: drinking water according to CSN 757111 ad libitum.
ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3 °C
- Humidity: 50 ± 15 %
- Photoperiod:12 hrs cycle dark /light
- Other: fluorescent light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved and abraded
- Vehicle:
- water
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied : 0.5 g - Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: an area of 6 cm × 6 cm was depilated. For the formation of scarified skin, four horizontal and four vertical incisions were made. Depilated area of skin outside of the application zone was used to control the assessment.
- Type of wrap if used: the sample was covered with gauze, above which aluminum film and cellulose wadding was applied. Technical tape was used so that the test substance was in contact with the depilated skin.
SCORING SYSTEM
The degree of erythema was diagnosed visually, and the degree of edema was assessed by visual examination and palpation, according to the OECD guideline 404.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal: 3/3
- Time point:
- 24/48/72 h
- Score:
- < 2.3
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- The mean erythema and edema score for the three rabbits is 0.
At 4, 24, 48 and 72 hours after removal of patch no rmacroscopic or pathomorphological changes were identified on the intact or scarified skin. The present sample after epicutaneous application to the skin of rabbits did not induce contact dermatitis.
Any other information on results incl. tables
Animal No | Reaction | Intact skin | Scarified skin | ||||||
4 hrs | 24 hrs | 48 hrs | 72 hrs | 4 hrs | 24 hrs | 48 hrs | 72 hrs | ||
14 | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
29 | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | |
30 | Erythema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Oedema | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified, according to the CLP Regulation (EC 1272/2008)
- Conclusions:
- Not irritant
- Executive summary:
The substance was evaluated for skin irritation/ corossion, according to OECD guideline 404. The test substance (0.5 g) was applied as a paste on the intact (left lateral depilated area) and scarified skin (right lateral depilated area) of three New Zealand white rabbits. Depilated area of skin outside the application zone was used to control the assessment.
After 4, 24, 48 and 72 hours of the removal of the patch the animals were examined for signs of erythema and ethema. No edema or erythema signs were identified on the intact skin and neither on the scarified skin.
Based on erythema and edema scores, the test substance is not considered to be irritating to the skin.
Conclusion
None of the animals showed any observable response to treatment throughout the 72 hours observation period, in both the cases of intact and scarified skin. Therefore, it can be concluded that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC 1272/2008).
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