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Diss Factsheets
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EC number: 700-403-8 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- - Purity: not reported as such
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 2491, 2520, 2742 g
- Housing: singly in suspended stainless steel cages with mesh floors. Enrichment (e.g., toy) was placed in each cage. Litter paper was placed beneath the cage and was changed at least 3 times per week.
- Diet (e.g. ad libitum): ad libitum, Pelleted Purina Rabbit Chow #5326
- Water (e.g. ad libitum): ad libitum, filtered tap water
- Acclimation period: 6 or 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21ºC
- Humidity (%): 56-68%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL - Duration of treatment / exposure:
- 4 hours.
- Observation period:
- Immediately following patch removal and at approximately 30-60 minutes and 24, 48, and 72 hours after patch removal.
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 6 cm²
- % coverage: 100%
- Type of wrap if used: The dose site was covered with a 1-inch x 1 inch, 4-ply gauze pad. The pad and entire trunk of each rabbit was wrapped with semi-occlusive tape. Elizabethan collars were placed on each rabbit.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance removed and the test sites gently cleansed of any residual test substance.
- Time after start of exposure: After 4 hours of exposure.
SCORING SYSTEM: Draize scoring system.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: calculated from the 24-, 48-, and 72-hour scores
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: calculated from the 24-, 48-, and 72-hour scores
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- There was no edema noted at any treated dose site during the study. Immediately following patch removal, very slight erythema was noted for two of three treated dose sites. Both animals were free from dermal irritation within 30-60 minutes. No clinical signs of toxicity were observed in any of the rabbits during the study and no body weight loss occurred. The dermal scores from individual animals with respect to observation time are presented in Table 1.
Any other information on results incl. tables
Table 1: Individual Skin Irritation Scores; Erythema/Edema
|
|
Time After patch Removal |
||||
Animal No. |
Sex |
Immediately after patch removal |
30-60 mins |
24 hrs |
48 hrs |
72 hrs |
3501 |
F |
1/0 |
0/0 |
0/0 |
0/0 |
0/0 |
3502 |
M |
0/0 |
0/0 |
0/0 |
0/0 |
0/0 |
3503 |
M |
1/0 |
0/0 |
0/0 |
0/0 |
0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- There was no edema noted at any treated dose site during the study. Immediately following patch removal, very slight erythema was noted for two of three treated dose sites. Both animals were free from dermal irritation within 30-60 minutes.
- Executive summary:
The study was conducted in a stepwise manner using a single patch applied initially to one rabbit for 4-hours. Five-tenths of a millilitre of the test substance was applied to the skin of one healthy rabbit for 4-hours. The dose site was evaluated for dermal irritation by the method of Draize et al immediately following patch removal, and at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since dermal irritation cleared within one hour in this animal, the test was completed on two additional animals. There was no edema noted at any treated dose site during the study. Immediately following patch removal, very slight erythema was noted for two of three treated dose sites. Both animals were free from dermal irritation within 30-60 minutes.
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.
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