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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 500-165-3 | CAS number: 66455-14-9 1 - 2.5 moles ethoxylated
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- Occlusive dressing; 24h exposure; 48h scoring is missing.
- GLP compliance:
- no
Test material
- Reference substance name:
- Alcohols, C12-13, ethoxylated
- EC Number:
- 500-165-3
- EC Name:
- Alcohols, C12-13, ethoxylated
- Cas Number:
- 66455-14-9
- Molecular formula:
- UVCB: Not available
- IUPAC Name:
- Alcohols, C12-13, ethoxylates, 1-2.5 EO
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- According to Guideline.
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: abraded and shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 7 days
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24+48+72 h
- Score:
- 1.9
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Only non-abraded skin - 48 h scoring is extrapolated.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24+48+72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Remarks on result:
- other: Only non-abraded skin - 48 h scoring is extrapolated.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
- Conclusions:
- Under the condition of this test classification is not justified.
- Executive summary:
The classification of TLGR 79.133 is based on a very rigorous treatment of the animals with the test material. Exposure to the test material for 24-hours under occlusive conditions is significantly higher than under the current OECD 404 prescribed exposure of 4-hours under semi-occluded conditions. Higher exposures will likely result in more severe effects. Hence, the results from this study over predict the irritation potential when assessed against new OECD 404 guidance criteria.
Additionally, the observation period in the previous studies is mostly restricted to 7 days (in contrast to the 14 day prescribed by the current guideline); which does not allow a full appreciation of the reversibility of the observed effects.
For one test substance from Shell it could be shown that different protocols result in contrasting results regarding the skin irritancy of the material (TLGR.0157.78 vs. SBGR.93.008; Cas-# 68131-39-5). When tested under current guidelines the material did not met the criteria for Skin irrit., cat. 2, H315.
Conclusions: As shown, just by changing the testing conditions to semi-occlusion and a shorter time period; test results for the same substance show a totally different picture. It can also be demonstrated by extending the observation period that the highest irritant responses are reversible. Hence, by weight of evidence and considering the testing conditions under both protocols Skin irrit., cat. 2, H315 is not justified.
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.