Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: - | 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
![](https://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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at the time of study conduct.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- Remarks:
- The study was conducted according to the guideline in effect at study conduct.
- GLP compliance:
- yes
Test material
- Details on test material:
- - Purity: 28 wt%
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:
- animal #1
- Time point:
- other: mean of the 24-, 48-, and 72-hour dermal responses
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean of the 24-, 48-, and 72-hour dermal responses
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean of the 24-, 48-, and 72-hour dermal responses
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean of the 24-, 48-, and 72-hour dermal responses
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean of the 24-, 48-, and 72-hour dermal responses
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean of the 24-, 48-, and 72-hour dermal responses
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- There was no edema noted at any treated dose site during the study. Erythema (score of 1) was noted at the treated site of all three rabbits immediately following patch removal and/or at the 30-60 minute scoring interval. All animals appeared active and healthy and gained body weight during the study. Apart from the dermal irritation, there were no other clinical signs observed. 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 |
M |
0/0 |
1/0 |
0/0 |
0/0 |
0/0 |
3502 |
M |
1/0 |
0/0 |
0/0 |
0/0 |
0/0 |
3503 |
M |
1/0 |
1/0 |
0/0 |
0/0 |
0/0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Classification not required Criteria used for interpretation of results: other: Directive 67/548/EEC
- Conclusions:
- The study and the conclusions which are drawn from it fulfil the quality criteria (validity, reliability, repeatability).
There was no edema noted at any treated dose site during the study. There was no edema observed at any treated dose during the study. Erythema (score of 1) was noted at the treated site of all three rabbits immediately following patch removal and/or at the 30-60 minute scoring interval. In accordance with the provisions of Directive 67/548/EEC, classification by the dermal route is not required based on the results of this study. According to the Globally Harmonized System (GHS) of classification and labelling of chemicals and under the conditions of this study, classification is not required. - 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 a.l immediately following patch removal, and at 30-60 minutes and 24, 48, and 72 hours after patch removal. Since irritation cleared by 24 hours and there was no significant dermal irritation noted at the dose site of this animal, the test was completed on two additional animals. There was no edema noted at any treated dose site during the study. Erythema (score of 1) was noted at the treated site of all three rabbits immediately following patch removal and/or at the 30-60 minute scoring interval.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Čeprav agencija ECHA veliko spletnega gradiva objavlja v vašem jeziku, je ta stran deloma še vedno v angleščini. Več informacij o večjezikovni praksi agencije.
Dobrodošli na spletišču agencije ECHA Vsebina na tej strani ni v celoti podprta z brskalnikom Internet Explorer 7 (in starejšimi različicami). Prosimo, nadgradite vaš brskalnik Internet Explorer na novejšo različico.
Ta stran uporablja piškotke za zagotavljanje najboljše možne uporabniške izkušnje na našem spletišču.
Preberite več o tem, kako uporabljamo piškotke.