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EC number: 272-939-6 | CAS number: 68921-42-6
- 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 Sensitization:
Based on all the available data, it was concluded that the test chemical is not likely to cause any sensitizing reactions on tested species and therefore is not likely to classify as a 'skin sensitizer' as per the CLP criteria of classification and labeling.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from safety assessment report
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Human Maximization Test
- Principles of method if other than guideline:
- To evalute skin sensitization potential of the test chemical in human for 12 days study period.
- GLP compliance:
- not specified
- Type of study:
- other: Human maximization test
- Justification for non-LLNA method:
- Not specified
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- No data available
- Route:
- other: no data
- Vehicle:
- water
- Concentration / amount:
- 5% aqueous solution
- Day(s)/duration:
- Not specified
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- other: no data
- Vehicle:
- water
- Concentration / amount:
- 5 % aqueous solution
- Day(s)/duration:
- Not specified
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 207 human volunteers
- Details on study design:
- induction phase of applications three times per week for three weeks was followed 12 days later by a challenge application
- Challenge controls:
- Not specified
- Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 %
- No. with + reactions:
- 0
- Total no. in group:
- 207
- Clinical observations:
- No local reactions of sensitisation was seen in 207 human volunteers
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- No local reactions (irritation or sensitisation) were seen in 207 human volunteers tested with daily skin applications of 5 % aqueous solution of the test chemical .Thus it can be considered that test substance was non sensitization to human skin.
- Executive summary:
The skin sensitization potential of the test chemical was evaluated on 207 human volunteers. The test chemical was used in the concentration 5% in aqueous solution. Induction phase was subjected three times per week for three weeks which was followed by challenge application after 12 days. No local reactions (irritation or sensitization) were seen in 207 human volunteers tested with daily skin applications of 5 % aqueous solution of the test chemical .Thus it can be considered that test substance was non sensitization to human skin.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from safety assesment report
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Principles of method if other than guideline:
- According to OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- No data available
- Vehicle:
- acetone/olive oil (4:1 v/v)
- Concentration:
- 0.5 – 4% in dimethylsulfoxide and in acetone/aqua (1:1) i.e. AA mixed with olive oil (4:1)
- No. of animals per dose:
- 50 females, divided into 10 groups of 5 animals
- Details on study design:
- On days 0, 1 and 2 the animals received 25 μl of one of the test preparations or vehicle on the dorsal surface of each ear. On day 5 all mice received intravenous injection of tritium labelled thymidine in phosphate buffered saline, and 5 hours later they were killed humanely and the draining auricular lymph nodes were removed. Single cell suspensions were prepared for each animal, appropriately treated and measured by liquid scintillation counting.
- Positive control substance(s):
- not specified
- Statistics:
- The stimulation indices were less than 3 at all tested concentrations, hence an EC3 value could not be calculated
- Positive control results:
- No data available
- Parameter:
- SI
- Value:
- > 3
- Test group / Remarks:
- The stimulation indices were less than 3 at all tested concentrations, hence an EC3 value could not be calculated
- Remarks on result:
- other: not sensitizing
- Cellular proliferation data / Observations:
- The stimulation indices were less than 3 at all tested concentrations, hence an EC3 value could not be calculated.
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The stimulation indices for the test chemical were less than 3 at all tested concentrations, hence an EC3 value could not be calculated. Therefore, the test chemical was considered to be not sensitizing to skin of mice.
- Executive summary:
Mouse local lymph node assay (LLNA) was performed to determine the allergic potential of the test chemical. The study was performed as per OECD Guidelines 429. 50 CBA:J female mice, divided into 10 groups of 5 animals were used for the study. On days 0, 1 and 2 the animals received 25 μl of one of the test chemical or vehicle on the dorsal surface of each ear. On day 5 all mice received intravenous injection of tritium labelled thymidine in phosphate buffered saline, and 5 hours later they were killed humanely and the draining auricular lymph nodes were removed. Single cell suspensions were prepared for each animal, appropriately treated and measured by liquid scintillation counting. The stimulation indices for the test chemical were less than 3 at all tested concentrations, hence an EC3 value could not be calculated. Therefore, the test chemical was considered to be not sensitizing to skin of mice.
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from safety assessment report
- Qualifier:
- according to guideline
- Guideline:
- other: Human maximization test
- Principles of method if other than guideline:
- Human maximization test was performed to evaluate skin sensitization potential of the test chemical on 207 human volunteers
- GLP compliance:
- not specified
- Type of study:
- other: Human maximization test
- Justification for non-LLNA method:
- Not specified
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- 207 human volunteers were used
- Parameter:
- SI
- Value:
- 0
- Remarks on result:
- other: Not sensitizing
- Cellular proliferation data / Observations:
- No skin irritation or reaction was observed
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The test chemical was applied on 207 human volunteers in the concentration 5% aqueous solution. No skin reaction was observed. Hence, the test chemical was considered to be not sensitizing to humans.
- Executive summary:
Human maximization test was performed to evaluate skin sensitization potential of the test chemical on 207 human volunteers
The test chemical was tested with daily skin applications of 5 % aqueous solution. An induction phase of applications three times per week for three weeks was followed 12 days later by a challenge application. No skin reaction was observed. Hence, the test chemical was considered to be not sensitizing to humans.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin Sensitization:
Various studies have been summarized to evaluate the allergic potential of the test chemical in living organisms. These include in vivo experimental studies on humans, mice for the test chemicals. They are summarized as follows:
The skin sensitization potential of the test chemical was evaluated on 207 human volunteers.
The test material was used in the concentration 5% in aqueous solution. Induction phase was subjected three times per week for three weeks which was followed by challenge application after 12 days.
No local reactions (irritation or sensitization) were seen in 207 human volunteers tested with daily skin applications of 5 % aqueous solution of the test chemical .Thus it can be considered that test substance was non sensitization to human skin.
This is supported by a Mouse local lymph node assay (LLNA) performed to determine the allergic potential of the test chemical. The study was performed as per OECD Guidelines 429. 50 CBA: J female mice, divided into 10 groups of 5 animals were used for the study. On days 0, 1 and 2 the animals received 25 μl of one of the test chemical or vehicle on the dorsal surface of each ear. On day 5 all mice received intravenous injection of tritium labelled thymidine in phosphate buffered saline, and 5 hours later they were killed humanely and the draining auricular lymph nodes were removed. Single cell suspensions were prepared for each animal, appropriately treated and measured by liquid scintillation counting. The stimulation indices for the test chemical were less than 3 at all tested concentrations, hence an EC3 value could not be calculated. Therefore, the test chemical was considered to be not sensitizing to skin of mice.
The above results are supported by a human maximization test was performed to evaluate skin sensitization potential of the test chemical on 207 human volunteers. The test chemical was tested with daily skin applications of 5 % aqueous solution. An induction phase of applications three times per week for three weeks was followed 12 days later by a challenge application. No skin reaction was observed. Hence, the test chemical was considered to be not sensitizing to humans.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Available results for the test chemical indicate a strong possibility that the test chemical may not be able to cause any reactions to the skin. Hence, the test chemical can be considered to be not sensitizing to skin and classified under the category “Not Classified” as per CLP Regulation.
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