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EC number: 272-782-3 | CAS number: 68911-68-2
- 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
Endpoint summary
Administrative data
Description of key information
Skin irritation
Key study
The study has been performed to the standardised guideline OECD 435. However, no statement of GLP has been made. The results of this study indicated that the sample was compatible with the Corrositex system and was classified as a Category 2 material. The results obtained from the evaluation of four replicate samples were highly reproducible, demonstrating that a mean time of >60 minutes required to destroy the synthetic biobarriers. These findings lead to the designation of the test material as a UN Non-corrosive and not a GHS Category 1 (InVitro International, 2016).
Eye irritation
Key study (in vivo)
In a study conducted according to the U.S. Federal Hazardous Substances Act, the test material when applied undiluted to the eyes of albino rabbits produced corneal opacity, conjunctivitis, iritis, and conjunctival bleeding. The test material is classified as a Category 1 according to GHS (Hill Top Research, Inc., 1971).
Waiver (in vitro)
An in vitro eye irritation does not need to be conducted because adequate data from an in vivo eye irritation are available; the study is scientifically not necessary as other information is available.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 February 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 435 (In Vitro Membrane Barrier Test Method for Skin Corrosion)
- Deviations:
- no
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- Not specified.
- Test system:
- artificial membrane barrier model
- Source species:
- other: Artificial barrier
- Cell type:
- other:
- Cell source:
- other: Not specified
- Source strain:
- other: Not applicable
- Vehicle:
- unchanged (no vehicle)
- Details on test system:
- A qualification test was performed to insure the test sample and the test reagent are compatible.
The second step of the Corrositex test utilizes appropriate indicator solutions to permit categorization of the test sample as either a Corrositex Category 1 or Corrositex Category 2 material. Corrositex Category 1 materials are typically strong acids/bases, while Corrositex Category 2 materials are typically weak acids/bases.
The third step in the test is performed by applying the test sample to the biobarrier. When the chemical permeates through or destroys the full thickness of this biobarrier, it comes into contact with the reagent which then undergoes a simple color change. This color change is visually observed and the time required for the color change to occur is recorded. - Control samples:
- no
- Amount/concentration applied:
- 150 µL
- Duration of treatment / exposure:
- 0 to 3 minutes, >3 to 60 minutes, >60 to 240 minutes, and >240 minutes.
- Duration of post-treatment incubation (if applicable):
- Not applicable
- Number of replicates:
- 4
- Irritation / corrosion parameter:
- penetration time (in minutes)
- Run / experiment:
- 1, 2, 3, and 4
- Value:
- > 60
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not applicable
- Positive controls validity:
- not applicable
- Remarks on result:
- other: Not corrosive
- Interpretation of results:
- Category 2 (irritant) based on GHS criteria
- Conclusions:
- Under the conditions of the study, the test material has been determined not to be corrosive.
- Executive summary:
The study has been performed to the standardised guideline OECD 435. However, no statement of GLP has been made. The results of this study indicated that the sample was compatible with the Corrositex system and was classified as a Category 2 material. The results obtained from the evaluation of four replicate samples were highly reproducible, demonstrating that a mean time of >60 minutes required to destroy the synthetic biobarriers. These findings lead to the designation of the test material as a UN Non-corrosive and not a GHS Category 1.
Reference
Summary of Corrositex®Test Results
Replicate |
Corrositex Time (minutes) |
1 |
>60 |
2 |
>60 |
3 |
>60 |
4 |
>60 |
Mean |
>60 |
Additional Test Information:
- Concentration of test material tested: Neat
- pH(10%) : 8.45
- Corrositex Category: 2
- UN Packing Group: Non-corrosive
- GHS Skin Corrosion Category: Not Category 1
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02 June 1971 to 09 September 1971
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Qualifier:
- according to guideline
- Guideline:
- other: U.S. Federal Hazardous Substances Act
- Version / remarks:
- September 17, 1964
- Deviations:
- no
- GLP compliance:
- no
- Specific details on test material used for the study:
- - Description: Viscous, amber liquid with an unpleasant odor
- Species:
- rabbit
- Strain:
- not specified
- Remarks:
- Albino
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 1 μL
- Observation period (in vivo):
- 24, 48 and 72 hours following application
- Details on study design:
- J. H. Draize, “Dermal Toxicity,” in Appraisal od the Safety of Chemicals in Foods, Drugs and Cosmetics, The Staff of the Division of Pharmacology of the Federal and Drug Administration (Austin, Texas: The Editorial Committee of the Association of Food and Drug Officials of the United States, 1959), p. 51.
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- > 16 - < 83
- Max. score:
- 110
- Reversibility:
- not fully reversible within: 72 hrs
- Remarks on result:
- positive indication of irritation
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Conclusions:
- Application of the test material to the eyes of albino rabbits produced corneal opacity, conjunctivitis, iritis, and conjunctival bleeding.
- Executive summary:
In a study conducted according to the U.S. Federal Hazardous Substances Act, the test material when applied undiluted to the eyes of albino rabbits produced corneal opacity, conjunctivitis, iritis, and conjunctival bleeding. The test material is classified as a Category 1 according to GHS.
Reference
Irritative effects included moderate or marked corneal opacity and conjunctivitis and mild iritis in each animal. Onset of these irritative effects was within 24 hours following application and they were relatively unchanged in five animals throughout the study. Irritative effects subsided significantly in the sixth animal. Four animals exhibited bleeding of the conjunctivae at the 24- and/or 48-hour observations.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
Justification for classification or non-classification
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.