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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Title 21, Code of Federal Regulations, 191.11.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Reaction products of C14-C18 (even numbered) and C14-C18-unsatd. (even numbered) fatty acids or triglycerides with diethanolamine
- Molecular formula:
- not applicable gor UVCB
- IUPAC Name:
- Reaction products of C14-C18 (even numbered) and C14-C18-unsatd. (even numbered) fatty acids or triglycerides with diethanolamine
- Test material form:
- liquid: viscous
- Details on test material:
- see Section 1.2 for detailed composition
Constituent 1
- Reference substance name:
- Amides, C18-unsatd., N,N-bis(hydroxyethyl)
- EC Number:
- 700-972-2
- Molecular formula:
- C22H43NO3
- IUPAC Name:
- Amides, C18-unsatd., N,N-bis(hydroxyethyl)
- Details on test material:
- - Name of test material (as cited in study report): Varamide A-7
- Specific details on test material used for the study:
- The discrepancy between originally usded identifier of the substance and new test material information is due to change in the main identifier through the Substance identity adaptation service offered by ECHA. The new identifier is covered by old identifier mentioned in Additional test material information section
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Housing: Screen bottom cages
- Diet (e.g. ad libitum): Laboratory chow, ad libitum
- Water (e.g. ad libitum): ad libitum - Type of coverage:
- semiocclusive
- Preparation of test site:
- other: one abraded area and one intact area
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL (0.5 g) of the 100% concentration of the test substance.
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 24 and 72 h
- Number of animals:
- Six
- Details on study design:
- TEST SITE
- Area of exposure: Backs and flanks of the animals were clipped hair free
- Test substance application: 0.5 mL (0.5 g) of the undiluted test substance was applied in an occlusive patch to the abraded and intact areas of the skin, covered with gauze patch by adhesive-tape.
Duration: 24 h
Scoring criteria: According to Draize classification.
Observations: at 24 and 72 h. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Time point:
- other: 24 and 72 h
- Score:
- 5.5
- Max. score:
- 8
- Reversibility:
- no data
- Other effects:
- None
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the conditions of the study, the test substance was irritating to skin.
- Executive summary:
A study was conducted to assess the irritation potential of the test substance to rabbit skin in accordance with Title 21, Code of Federal Regulations, 191.11. Six animals were treated with undiluted test substance (0.5 mL or 0.5 g). The treated areas were covered with a semi-occlusive gauze patch and taped to maintain the test substance in contact with the skin for 24 h. The degree of erythema and edema was recorded according to the Draize scoring system after 24 and 72 h. Moderate to severe erythema and defined edema was observed at 24 h and moderate to severe erythema and moderate edema was observed at 72 h on the abraded and intact rabbit skin. The mean primary skin irritation index (PII) was 5.5. Under the conditions of the study, the test substance was irritating to skin (Casey, 1976).
Reference
Constituent 1
Test animals
Test system
Results and discussion
In vivo
Results
Any other information on results incl. tables
Results for the primary skin irritation of the abraded and intact skin at 24 and 72 hrs:
Animal number |
24 h |
72 h |
||
Abraded |
Intact |
Abraded |
Intact |
|
1 |
3-2 |
3-2 |
3-3 |
3-3 |
2 |
3-2 |
3-2 |
3-3 |
3-3 |
3 |
3-2 |
3-2 |
3-3 |
3-3 |
4 |
3-2 |
3-2 |
3-3 |
3-3 |
5 |
3-2 |
3-2 |
3-3 |
3-3 |
6 |
3-2 |
3-2 |
3-3 |
3-3 |
Scoring was done similar to the Draize system of classification.
Observations: Moderate to severe erythema and defined edema was observed at 24 h and moderate to severe erythema and moderate edema was observed at 72 h on abraded and intact rabbit skin.
The mean primary skin irritation index obtained = 5.50 (mean of erythema and edema scores at 24 and 72 h).
Applicant's summary and conclusion
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.