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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-509-8 | CAS number: 107-66-4
- 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
An in-vitro test for skin corrosion on a reconstructed human epidermis was performed with the test item and showed corrosive properties in vitro.
In an eye irritation test on rabbits, performed in 1978, the test item showed severe eye damage to the eyes. No reversibility of the effects was shown within the observation time of 7 days.
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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 431
- Principles of method if other than guideline:
- The experiment was carried out on a reconstructed human epidermis EST-1000 (CeIlSystems, St. Katharinen, Germany).
- GLP compliance:
- yes
- Test system:
- human skin model
- Remarks:
- EST-1000 (Cell Systems, St. Katharinen, Germany)
- Source species:
- human
- Cell type:
- other: reconstructed 3D human epidermis
- Vehicle:
- unchanged (no vehicle)
- Amount/concentration applied:
- 50 mL of the neat liquid test item
- Duration of treatment / exposure:
- incubation periods of 3 min and 60 min
- Duration of post-treatment incubation (if applicable):
- no post-treatment incubation period; 3 hours incubation with MRR solution
- Number of replicates:
- 3
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 3 min treatment
- Value:
- 64.38
- Negative controls validity:
- valid
- Remarks on result:
- other: mean of 3 samples compared to negative control (NaCl, 0.9%, set to 100% viability)
- Irritation / corrosion parameter:
- % tissue viability
- Remarks:
- 60 min treatment
- Value:
- 1.79
- Negative controls validity:
- valid
- Remarks on result:
- other: mean of 3 samples compared to negative control (0.9% NaCl, set to 100% viability)
- Interpretation of results:
- Category 1B (corrosive) based on GHS criteria
- Executive summary:
A study for predicting non-specific, corrosive potentials of compounds by using reconstructed human skin (RHS) was performed. The experiment was carried out on a reconstructed human epidermis EST-1000 (CellSystems, St. Katharinen, Germany) for detection of topically applied skin corrosives with the test item dibutyl hydrogen phosphate.
Corrosive skin effects of substances are defined as irreversible damage of skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to four hours. In vivo corrosive reactions are typified by ulcers, bleeding, and bloody scabs.
A 100% concentration was tested on the skin/epidermal equivalents in triplets. For the determination of time related cytotoxic effects the incubation periods were 3 min. and 60 min., respectively. By this the study, was conducted in accordance with the OECD 431 guideline using the test item concentrations and incubation periods recommended there. These tests are also related to the revised OECD 404 guideline "Acute Dermal Irritation/Corrosion".
The test item was applied at a 100% concentration, i.e. 50µl per insert.
The MTT (Methylthiazoletetrazolium) method has determined the following values of viability after 3 min. or after 60 min. of incubation: 64% and 2% (rounded), respectively.
Thus, the results show that a corrosive property of the test item was determined by the assay used.
Reference
Compound [%] Cell viability 3 min [%] Cell viability 60 min Classification*
test item 64.36 1.79 Corrosive
Negative control 100 100 Negative control
* Classification was done in accordance with the existing guideline and internationally accepted protocols, i.e. evaluation of LD50 values after 3 min. and/or less than 15% viability after a 60 min. incubation period.
Substances are classified as "corrosive (R34)", if the cell viability of the EST 1000 is decreased by more than 50% after 3 min. of incubation to the test item, or if the cell viability is less than 15% after 60 min. of exposure to the test item.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (corrosive)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: scientifically acceptable and sufficient documented
- Principles of method if other than guideline:
- 100 µl test substance was applied into the conjunctival sac of 2 rabbits. Post exposure time was 7 days. Eyes were examined after application of test substance up to 7 days.
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2 animals
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 2.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 4
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- iris score
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- chemosis score
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- not reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- not reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 7 d
- Score:
- 1.5
- Max. score:
- 4
- Reversibility:
- not reversible
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Executive summary:
The test substance was (100 µl) was applied into the conjuctival sac of 2 rabbits. Post exposure time was 7 days. Eyes were examinated after application of test substance up to 7 days.
Effects on the cornea, iris, conjunctiva and chemosis were persistent up to the end of the observation period (7 days).
Reference
The test substance causes corrosion to the cornea.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A study for predicting non-specific, corrosive potentials of compounds by using reconstructed human skin (RHS) was performed. The experiment was carried out on a reconstructed human epidermis EST-1000 (CellSystems, St. Katharinen, Germany) for detection of topically applied skin corrosives with the test item dibutyl hydrogen phosphate. For the determination of time related cytotoxic effects the incubation periods were 3 min. and 60 min., respectively. By this the study, was conducted in accordance with the OECD TG 431 guideline using the test item concentrations and incubation periods recommended there. The MTT (Methylthiazoletetrazolium) method has determined the following values of viability after 3 min. or after 60 min. of incubation: 64% and 2% (rounded), respectively. This result leads to classification as corrosive (Cat 1B).
In an in vivo eye irritation study in rabbits, performed in 1978, the test substance was applied into the conjuctival sac of 2 rabbits. Effects on the cornea, iris, conjunctiva and chemosis were persistent up to the end of the observation period (7 days). The test substance was thus classified as severly damaging the eyes.
Justification for classification or non-classification
Due to the results of an in-vitro skin corrosion study a classification as Skin Corr. 1B; H314: Causes severe skin burns and eye damage is justified according to CLP classification criteria (Regulation (EC) No 1272/2008).
Based of an in vivo eye irritation study a classification as Eye Dam.1; H318: Causes serious eye damage is justified according to CLP classification criteria (Regulation (EC) No 1272/2008).
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.