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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 215-582-3 | CAS number: 1333-22-8
- 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
The potential of the test substance to induce skin sensitisation was assessed using the Magnusson and Kligman Maximisation Test according to OECD Guideline 406: Skin Sensitisation (17 July 1992) (source: study report, EVIC France, 2004).
The percentage of animals that were sensitised was 0 out of 10 (0% sensitisation rate). No reactions were observed in the five control animals (0% reaction rate). The test item was therefore found to be non-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:
- experimental phase was conducted between 08 July 2004 and 08 August 2004. The report was issued 20 September 2004.
- 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
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Pre-existing study.
- Species:
- guinea pig
- Strain:
- Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Male and female Hartley albino guinea-pigs obtained from S.C.E.A (24610 Villefranche-de-Lonchat, France) were used for the study. A total of nine animals were used for the preliminary testing and 16 for the main test. The animals were acclimatised for at least 5 days before the beginning of the test. They weighed less than or equal to equal to 500 g (main test).
Identification: each animal was identified individually by auricular ring and the corresponding number was written on a label put on its cage.
Housing: the animals were housed at the rate of 1 per cage, in 31 cm x 46 cm x 19 cm polypropylene cages with stainless steel lid. The litter renewed regularly was composed of dust-free wood shavings. The cages were placed in limited-access premises, of 7 m x 4 m x 3 m, maintained in slight over-pressure (a minimum of 10 mm of water), under air-conditioned temperature (t = 21 ± 3°C) and controlled relative humidity (RH = SO ± 20 %) except during washing cycles. Air changes of non-recycled filtered air was performed at the rate of about 10 cycles per hour. The artificial lighting ensured a sequence of 12 hours light, 12 hours dark.
Feeding: food was supplied in pelleted form 106, which guaranteed an appropriate ascorbic acid content and was sourced from UAR (91360 Epinay sur orge, France).
Drinking: the tap water was distributed in polypropylene bottles with stainless steel teat. A sample of water is taken at least every six months and subject for chemico-physical and bacteriological analysis at a specialist laboratory. - Route:
- intradermal
- Vehicle:
- other: distilled water
- Concentration / amount:
- 80%, 0.1 ml
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: distilled water
- Concentration / amount:
- 80% / 0.2ml
- Day(s)/duration:
- 2
- No. of animals per dose:
- Control = 5.
Treated = 10. - Details on study design:
- Intradermal injections
Control group = group 1
Three pairs of intradermal injections of 0.1 ml volume were given in the shoulder region cleared of hair on each side of the midline.
1) FCA diluted at 50 % with distilled water (v/v)
2) Distilled water (vehicle)
3) mixture 50/50 of the solutions 1 and 2 (v/v)
Treated group = group 2
Three pairs of intradermal injections of 0.1 ml volume were given in the same sites and order as in the control animals.
1) FCA diluted at 50 % with distilled water (v/v)
2) test item at the dose previously defined (MICm)
3) test item at the same dose as in 2 in a 50/50 mixture (v/v) of FCA and distilled water (v/v) (the mixture was homogenized by successive suckings and forcings back with a syringe without needle).
In injection 3, the water soluble test item was dissolved in the aqueous phase prior to mixing with FCA. Injections 1 and 2 were given close to each other and nearest the head, while the injection 3 was given towards the caudal part of the test area. - Positive control substance(s):
- no
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 80%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None reported.
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 80%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None Reported
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 80%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- None reported
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None reported.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None reported
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- None reported.
- Key result
- Reading:
- other: The positive control was run as a separate study to confirm the responsiveness of the test animals.
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 20% w/w
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not a skin sensitiser based on the results of the test.
- Executive summary:
Introduction
The potential of the test substance to induce skin sensitisation was assessed using the Magnusson and Kligman Maximisation Test according to OECD Guideline 406: Skin Sensitisation (17 July 1992).
Method
Fifteen guinea-pigs (10 treated, 5 control) were used to assess the skin sensitisation potential of the test susstance. The effect was potentiated by the injection of Freund's Complete Adjuvant. The 10 treated animals were exposed to the test substance by intradermal injection at the concentration of 0.1 % with distilled water and epidermal application at the concentration of 80 % with distilled water. Concurrently, the 5 control animals received the vehicle (distilled water) only by intradermal and epidermal application.
Following a rest period of 10 to 14 days ending the induction period, all the animals were exposed to the non-irritant challenge dose of 80 % with distilled water. The extent and degree of skin reaction to the challenge exposure in the test animals were compared with those demonstrated by control animals.
Results
The percentage of animals that were sensitised was 0 out of 10 (0% sensitisation rate). No reactions were observed in the five control animals (0% reaction rate).
Conclusion
The test item was found not to induce skin sensitisation and was therefore classified as negative for the potential to induce skin sensitisation.
Reference
Main Test.
No mortality occurred during the test.
The percentage of reactive treated animals was 0%.
The percentage of reactive control animals was 0%.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Justification for classification or non-classification
The test item was found not to induce skin sensitisation and was therefore classified as negative for the potential to induce skin sensitisation.
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.