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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 436-010-0 | CAS number: 422278-61-3 PRIMID V40-32
- 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
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:
- From Apr 11th to May 22nd, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was perfomed in 2001. At the time there was no OECD guideline regarding LLNA method.
- Species:
- guinea pig
- Strain:
- other: Ibm: GOHI (Himalayan spotted)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd Biotechnology and Animal Breeding Division, Wolferstrasse 4, CH-4414 Fullinsdorf/Switzerland
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 367-388 g
- Housing: Individually in makrolon type-4 cages with standard softwood bedding.
- Diet (e.g. ad libitum): Pelleted standard Kliba 3418, batch no. 33/00 and 90/01, guinea pig maintenance diet (Provimi Kliba AG, CH-4303 Kaiseraugst) available ad libitum.
- Water (e.g. ad libitum): Community tap water available ad libitum.
- Acclimation: Under laboratory conditions, after health examination. Only animals without any visible signs of illness were used for the study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 °C
- Humidity (%): 30-70 %
- Air changes (per hr): 10-14
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Remarks:
- selected on the basis of preliminary solubility testing
- Concentration / amount:
- Intradermal induction: 3% in corn oil
Epidermal induction: 50% in corn oil
Epidermal challenge: 15% in corn oil - Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Remarks:
- selected on the basis of preliminary solubility testing
- Concentration / amount:
- Intradermal induction: 3% in corn oil
Epidermal induction: 50% in corn oil
Epidermal challenge: 15% in corn oil - No. of animals per dose:
- 10
- Positive control substance(s):
- yes
- Remarks:
- 2-mercaptobenzothiazole
- Positive control results:
- All test animals (10) showed discrete/patchy to moderate/confluent erythema after the challenge treatment with 2-mercaptobenzothiazole at 1% (w/w) in mineral oil.
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 15% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: . Hours after challenge: 24.0. Group: test group. Dose level: 15% in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 15% in corn oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: . Hours after challenge: 48.0. Group: test group. Dose level: 15% in corn oil. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None
- Remarks on result:
- other: . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- No toxic symptoms were evident in the guinea pigs of the test group.
Hence, the substance is not sensitizer. - Executive summary:
A Maximisation test was performed in accordance with OECD Guideline 406.
The intradermal induction of sensitization in the test group was perfomed in the nuchal region with a 3% dilution of the test item in corn oil and in an emulsion of Freund's Complete Adjuvant (FCA)/physiological saline. The epidermal induction of sensitization was conducted for 48 hours under occlusion with the test item at 50% in corn oil one week after the intradermal induction. The animals in the control group were intradermally induced with corn oil and FCA/physiological saline and epidermally induced with corn oil under occlusion.
Two weeks after epidermal induction the control and test animals were challenged by epidermal application of the test item at 15% in corn oil and corn oil alone under occlusive dressing.
Cutaneous reactions were evaluated at 24 and 48 hours after removal of the dressing.
No toxic symptoms were evident in the guinea pigs of the control or the test group. No deaths occured. None of the control and test animals showed skin reactions after the challenge treatment with the substance at 15% in corn oil.
2 -mercaptobenzothiazole was used as positive control. All test animals (10) showed discrete/patchy to moderate/confluent erythema after the challenge treatment with 2-mercaptobenzothiazole at 1% (w/w) in mineral oil.
Based on these findings, the experiment was considered valid and the conclusion is that the substance is not sensitizer.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
No toxic/sensitising effects were evident in a valid Maximisation test study on Guinea pigs, according to OECD TG 406.
All animals survived the test and the substance showed no treatment related effects.
On the basis of this result, the substance should not be classified as sensitizer, according to 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.