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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 684-597-9 | CAS number: 1072005-10-7
- 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
No data on the test item is available. With the read-across substance the following result was obtained:
CAS 853947-59-8: not sensitising
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 02.12.1991 - 03.01.1992
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- February 1987
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Guinea Pig Test (1992) met the previous requirements before the entry into force of REACH. The test is suitable and reliable to cover this endpoint. For this reason and for animal welfare reasons, no further in vivo study (LLNA test) needs to be performed.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Remarks:
- Pirbright White Bor: DHPW [SPF]
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, D-W-4799 Borchen
- Age at study initiation: young
- Weight at study initiation: 362 - 467 g
- Housing: Maximum 5 animals/type IV Makrolon cage
- Diet: Ssniff G 4 complete feed for guinea pigs, supplied by Ssniff Spezialfutter GmbH, D-W-4770 Soest
- Water: Drinking water ad libitum, supplied by Gelsenwasser, waterworks, D-W-4358 Haltern
- Acclimation period: at least 5 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3°C
- Humidity (%): 30-70% (deviations due to cleaning of the animal room and function checks on the thermohygrograph)
- Photoperiod: Artificial light, 12-hour light/dark rhythm
- IN-LIFE DATES: From: To: 02.12.1991 - 03.01.1992 - Route:
- intradermal
- Vehicle:
- corn oil
- Concentration / amount:
- 10 %
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 0.3 cm³
- Day(s)/duration:
- 48 h
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 %
- Day(s)/duration:
- 24 and 48 h
- No. of animals per dose:
- 20 animals per dose
- Details on study design:
- RANGE FINDING TEST:
All the test substance concentrations (0.25; 0.5; 1.0; 2.5; 5 and 10% in maize germ oil MEH 56) and the pure vehicle caused very slight erythema and well-defined oedema at the injection sites in both animals 24 hours after the intracutaneous administration. On the basis of these results, a 10% formulation of the substance in maize germ oil MEH 56 was chosen for the intracutaneous induction in the main test. None of the test substance concentrations administered (2.5; 25; 50 and 100%) caused dermal reactions 48 and 72 hours after administration so that the 100% test substance was used for the dermal administration in the main test.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2
- Test groups: 20 animals
- Control group: 10 animals
- Site: on the shoulder
- Frequency of applications: once
- Concentrations: 10 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Days of challenge: 7
- Exposure period: 24 h
- Test groups: 20 animals
- Control group: 10 animals
- Site: right flank
- Concentrations: 100%
- Evaluation (hr after challenge): 48 and 72 h - Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Group:
- test chemical
- Remarks on result:
- not measured/tested
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a Magnusson and Kligman maximisation test groups of guinea pigs showed no sensitizing effects.
- Executive summary:
The sensitising potential of the test item was determined using a test group of 20 animals and two control groups each of 10 animals for the test. All the reactions, especially the formation of erythema and oedema, were assessed 48 and 72 hours after the challenge treatment. The following concentrations of test substance were used for the induction treatments: the test substance was employed in a 10% mixture with maize germ oil MEH 56 for the intracutaneous injection, while the 100% test substance was used for the dermal treatment. The preliminary tests showed that the undiluted test substance caused no dermal irritation. In order to induce slight to moderate dermal inflammation, 24 hours before the dermal induction treatment the skin in the injection area was pretreated with sodium dodecyl sulphate (10% in vaseline). The reactions to the dermal induction treatment were assessed 49 and 72 hours after administration. Distinct redness and swelling was found at the injection sites treated with 10% test substance in maize germ oil MEH 56 49 hours after administration. Scaling was detected at the injection sites after 24 hours. Severe erythema and severe oedema occurred 49 hours after administration in 19/20 test animals at the injection sites treated with 10% test substance in Freund's Adjuvant (diluted 1+1 with maize germ oil MEH 56). One animal had well-defined reddening and swelling. Nine animals were found to have deep damage. 24 hours later (72 hours after administration) 19 animals were found to have severe erythema with deep damage and severe oedema. One animal had moderately severe redness and swelling. The control animals had comparable signs of irritation at the injection sites at these times. The first challenge treatment was carried out with the 100% test substance. No signs of dermal irritation were found on the test animals or the control animals 48 hours and 72 hours after the challenge treatment. No second challenge was carried out. On the basis of these results, the test item is assessed as having no sensitising effect on the skin of guinea pigs.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- Please refer to Chapter 13.
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Group:
- test chemical
- Remarks on result:
- not measured/tested
- Group:
- positive control
- Remarks on result:
- not measured/tested
Referenceopen allclose all
The reactions to the dermal induction treatment were assessed 49 and 72 hours after administration. Distinct redness and swelling was found at the injection sites treated with 10% test substance in maize germ oil MEH 56 49 hours after administration. Scaling was detected at the injection sites after 24 hours. Severe erythema and severe oedema occurred 49 hours after administration in 19/20 test animals at the injection sites treated with 10% test substance in Freund's Adjuvant (diluted 1+1 with maize germ oil MEH 56). One animal had well-defined reddening and swelling. Nine animals were found to have deep damage. 24 hours later (72 hours after administration) 19 animals were found to have severe erythema with deep damage and severe oedema. One animal had moderately severe redness and swelling. The control animals had comparable signs of irritation at the injection sites at these times. The first challenge treatment was carried out with the 100% test substance. There were no signs of skin irritation in the administration area 24 and 48 hours after removal of the occlusive dressing (48 h and 72 h after administration) either in the test animals or in the animals in control group. No second challenge was carried out because the above result was unambiguous.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
No data on the test item is available. With the read-across substance the following result was obtained:
The sensitising potential of the read across substance CAS 853947-59-8 was determined using a test group of 20 animals and two control groups each of 10 animals for the test. All the reactions, especially the formation of erythema and oedema, were assessed 48 and 72 hours after the challenge treatment. The following concentrations of test substance were used for the induction treatments: the test substance was employed in a 10% mixture with maize germ oil MEH 56 for the intracutaneous injection, while the 100% test substance was used for the dermal treatment. The preliminary tests showed that the undiluted test substance caused no dermal irritation. In order to induce slight to moderate dermal inflammation, 24 hours before the dermal induction treatment the skin in the injection area was pretreated with sodium dodecyl sulphate (10% in vaseline). The reactions to the dermal induction treatment were assessed 49 and 72 hours after administration. Distinct redness and swelling was found at the injection sites treated with 10% test substance in maize germ oil MEH 56 49 hours after administration. Scaling was detected at the injection sites after 24 hours. Severe erythema and severe oedema occurred 49 hours after administration in 19/20 test animals at the injection sites treated with 10% test substance in Freund's Adjuvant (diluted 1+1 with maize germ oil MEH 56). One animal had well-defined reddening and swelling. Nine animals were found to have deep damage. 24 hours later (72 hours after administration) 19 animals were found to have severe erythema with deep damage and severe oedema. One animal had moderately severe redness and swelling. The control animals had comparable signs of irritation at the injection sites at these times. The first challenge treatment was carried out with the 100% test substance. No signs of dermal irritation were found on the test animals or the control animals 48 hours and 72 hours after the challenge treatment. No second challenge was carried out. On the basis of these results, the test item is assessed as having no sensitising effect on the skin of guinea pigs.
Based on the results of the read across substance the test item is having no sensitising effect on the skin.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on available data on skin sensitisation, the test item is classified and labelled as not skin sensitisation according to Regulation (EC) No 1272/2008 (CLP), as amended for the tenth time in Regulation (EU) No 2017/776.
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.