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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 297-755-3 | CAS number: 93762-42-6
- 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
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also tend to behave in a similar manner. Therefore, the test chemical was estimated to be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Remarks:
- Weight of evidence report based in various test chemicals
- Justification for type of information:
- Weight of evidence report based in various test chemicals
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: Weight of evidence report based in various test chemicals
- Principles of method if other than guideline:
- Weght of evidence report based in various test chemicals. The study 2,3 are referred as study
- GLP compliance:
- not specified
- Type of study:
- other: Weight of evidence report based in various test chemicals
- Justification for non-LLNA method:
- Currently no LLNA Study is available for assessment.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Route:
- intradermal
- Vehicle:
- other: water-in-oil type emulsion
- Concentration / amount:
- aliquots of 0.1 ml each of a water-in-oil type emulsion (distilled water: FCA =1:1) were injected intradermally into the four corners of a previously shaved shoulder region (2 cm×4 cm)
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1 ml of purified test preparation (1, 0.1 and 0.01%)
- Day(s)/duration:
- 24 h
- Adequacy of induction:
- not specified
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- a 0.1 ml intradermal injection of Freund’s Complete Adjuvant (FCA) diluted to 50% in sterile isotonic saline
- Day(s)/duration:
- day 0, day 10
- Adequacy of induction:
- not specified
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.5 ml of undiluted test chemical
- Day(s)/duration:
- three times per week at 2-day intervals
- Adequacy of induction:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 0.5 ml aqueous solution of the test chemical at a concentration of 25% (w/w)
- Day(s)/duration:
- 48 h
- Adequacy of challenge:
- not specified
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.1 ml of purified test preparation (1, 0.1 and 0.01%)
- Day(s)/duration:
- 24 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- 1. 20 guinea pigs
2. no data available - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Group:
- test chemical
- No. with + reactions:
- 0
- Clinical observations:
- no dermal reactions observed
- Remarks on result:
- no indication of skin sensitisation
- Interpretation of results:
- other: not sensitizing
- Conclusions:
- Based on the available data for the various studies, it can be concluded that the test chemical will also tend to behave in a similar manner. Therefore, the test chemical was estimated to be not sensitizing to skin. Comparing the above annotations with the criteria of CLP regulation, the test chemical can be classified under the category “Not Classified”.
- Executive summary:
Various studies have been summarized to ascertain the level of dermal sensitization caused by the test chemical in living organisms. These results include in vivo experimental studies performed on guinea pigs for the various test chemicals.
A study was performed to determine the Contact Sensitization caused by the test chemical in Guinea Pigs. Two preliminary studies were conducted to determine the challenge concentration of the test compound to be used in the principal study. Twenty (20) Hartley albino guinea pigs -10 males, 10 females were used for the study. The treatment region for each animal was clipped once a week. Guinea pigs were administered a 0.1 ml intradermal injection of Freund’s Complete Adjuvant (FCA) diluted to 50% in sterile isotonic saline on days 1 and 10 of the study. Beginning on day 1 of the study, 0.5 ml of undiluted test chemical was applied topically to the treatment site (which was just above the injection site) three times per week at 2-day intervals and once at the beginning of the fourth week. It was applied using a 2 cm² square of gauze that was moistened with water and kept in place by an occlusive patch. Treatment was suspended on day 24; the challenge application of a 0.5 ml aqueous solution of the test chemical at a concentration of 25% (w/w) was administered on untreated skin on the clipped left flank of the guinea pigs on day 36 of the study. This application was left on the skin for 48 hours under an occlusive patch. The skin was evaluated for evidence of sensitization, e.g. erythema and oedema, at 1, 6, 24 and 48 hours after removal of the patch. Treatment sites were biopsied 6-7 hours after patch removal due to staining of the skin that prevented evaluation of erythema at the treatment site. Four males and one female died during the course of the study; these deaths were not attributed to compound administration. No oedema was observed during the study. No abnormal histopathological findings were observed. Hence,the test chemical can be considered to be not sensitizing to the skin of guinea pigs.
This is supported by a study in which a modified guinea pig testing technique, the adjuvant and patch test was adapted to evaluate the contact hypersensitivity of test chemical on Hartley strain female albino guinea pigs. In intradermal induction, aliquots of 0.1 ml each of a water-in-oil type emulsion (distilled water: FCA =1:1) were injected intradermally into the four corners of a previously shaved shoulder region (2 cm×4 cm). At the injection sites, scratches in the shape of agrid were made with the needle used for injection.During topical induction, a closed patch with 0.1 ml of purified test preparation (1, 0.1 and 0.01%) was applied to the sites for 24 h. Abrasions and sample applications were repeated on the following 2 days. One week after the initial sensitization, 10% sodium lauryl sulfate in petrolatum was applied to the intradermal injection sites. On the next day, a closed patch of the test preparation was applied at the same sites for 48 h. After a rest period of 2 weeks, animals were challenged with the same purified test preparations (1, 0.1 and 0.01%) onto the shaved skin of the back. The excess substance was removed from the skin by washing with acetone at 24 h after the challenge application procedure. The skin reactions, fractional response (FR) and mean response (MR), were scored at 1, 24 and 48 h after the washing. The fractional response (FR) and mean response (MR) was observed to be 0.0 at each tested concentration. Since no response was detected to purified test preparation (1, 0.1 and 0.01%) in test and control group, the chemical was considered to be not sensitizing to the skin of Hartley strain female albino guinea pigs.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also tend to behave in a similar manner. Therefore, the test chemical was estimated to be not sensitizing to skin. Comparing the above annotations with the criteria of CLP regulation, the test chemical can be classified under the category “Not Classified”.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Various studies have been summarized to ascertain the level of dermal sensitization caused by the test chemical in living organisms. These results include in vivo experimental studies performed on guinea pigs for the various test chemicals.
A study was performed to determine the Contact Sensitization caused by the test chemical in Guinea Pigs.
Two preliminary studies were conducted to determine the challenge concentration of the test compound to be used in the principal study.
Twenty (20) Hartley albino guinea pigs -10 males, 10 females were used for the study. The treatment region for each animal was clipped once a week. Guinea pigs were administered a 0.1 ml intradermal injection of Freund’s Complete Adjuvant (FCA) diluted to 50% in sterile isotonic saline on days 1 and 10 of the study. Beginning on day 1 of the study, 0.5 ml of undiluted test chemical was applied topically to the treatment site (which was just above the injection site) three times per week at 2-day intervals and once at the beginning of the fourth week. It was applied using a 2 cm² square of gauze that was moistened with water and kept in place by an occlusive patch. Treatment was suspended on day 24; the challenge application of a 0.5 ml aqueous solution of the test chemical at a concentration of 25% (w/w) was administered on untreated skin on the clipped left flank of the guinea pigs on day 36 of the study. This application was left on the skin for 48 hours under an occlusive patch. The skin was evaluated for evidence of sensitization, e.g. erythema and oedema, at 1, 6, 24 and 48 hours after removal of the patch. Treatment sites were biopsied 6-7 hours after patch removal due to staining of the skin that prevented evaluation of erythema at the treatment site.
Four males and one female died during the course of the study; these deaths were not attributed to compound administration. No oedema was observed during the study. No abnormal histopathological findings were observed.
Hence, the test chemical can be considered to be not sensitizing to the skin of guinea pigs.
This is supported by a study in which a modified guinea pig testing technique, the adjuvant and patch test was adapted to evaluate the contact hypersensitivity of test chemical on Hartley strain female albino guinea pigs.
In intradermal induction, aliquots of 0.1 ml each of a water-in-oil type emulsion (distilled water: FCA =1:1) were injected intradermally into the four corners of a previously shaved shoulder region (2 cm×4 cm). At the injection sites, scratches in the shape of agrid were made with the needle used for injection.
During topical induction, a closed patch with 0.1 ml of purified test preparation (1, 0.1 and 0.01%) was applied to the sites for 24 h. Abrasions and sample applications were repeated on the following 2 days. One week after the initial sensitization, 10% sodium lauryl sulfate in petrolatum was applied to the intradermal injection sites. On the next day, a closed patch of the test preparation was applied at the same sites for 48 h. After a rest period of 2 weeks, animals were challenged with the same purified test preparations (1, 0.1 and 0.01%) onto the shaved skin of the back. The excess substance was removed from the skin by washing with acetone at 24 h after the challenge application procedure.
The skin reactions, fractional response (FR) and mean response (MR), were scored at 1, 24 and 48 h after the washing.
The fractional response (FR) and mean response (MR) was observed to be 0.0 at each tested concentration.
Since no response was detected to purified test preparation (1, 0.1 and 0.01%) in test and control group, the chemical was considered to be not sensitizing to the skin of Hartley strain female albino guinea pigs.
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also tend to behave in a similar manner. Therefore, the test chemical was estimated to be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available data for the various test chemicals and applying the weight of evidence approach, it can be concluded that the test chemical will also tend to behave in a similar manner. Therefore, the test chemical was estimated to be not sensitizing to skin.Comparing the above annotations with the criteria of CLP regulation,the test chemicalcan be classified under the category “Not Classified”.
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.