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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 251-459-0 | CAS number: 33329-35-0
- 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
![](https://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 1991-1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guidleine study performed under GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was already existing at the moment of the registration. Therefore we do not conduct a LLNA study because animal welfare reasons.
- Species:
- guinea pig
- Sex:
- female
- Route:
- intradermal
- Vehicle:
- physiological saline
- Concentration / amount:
- The test substance ws diluted to 2.5 (wlw) with physiological saline,
- Route:
- epicutaneous, occlusive
- Vehicle:
- physiological saline
- Concentration / amount:
- The test substance ws diluted to 2.5 (wlw) with physiological saline,
- No. of animals per dose:
- Experimental group: 20 females
Control group : 10 females - Details on study design:
- The intradermal route of administration (first induction) was selected in order to obtain optimal contact between POLYCAT 9 and elements of the immunosystem. Freunds Complete Adjuvant (FCA) was added to attract circulating immunocompetent cells to the injected area.
The dermal route of administration (second induction and challenge) was 5 selected because POLYCAT 9 may accidentally come into contact with the skin during manufacture, handling and use. - Challenge controls:
- The test and control guinea pigs were challenged two weeks after the epidermal induction application.
Hair was clipped and shaved from a 5 x 5 cm area on the left flank of each guinea pig. A volume of 0.05 ml of each of the following three test substance concentrations and the vehicle were applied using Square chambers attached to Micropore tape:
a = 5 % (wlw) in distilled water.
b = 2 % (wlw) in distilled water.
c = 1 % (wlw) in distilled water.
d = distilled water. - Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 8
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Group:
- positive control
- Dose level:
- 0.5%
- No. with + reactions:
- 12
- Total no. in group:
- 20
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 0
- Group:
- positive control
- Dose level:
- 0.5%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: positve control formaldheyde with 0.5% concentration
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 - 50 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 5 - 50%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5 - 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No symptoms of systemic toxicity were observed in the animals during the study. No mortality occurred during the study.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals during the study. No mortality occurred during the study..
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5 - 50%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- No symptoms of systemic toxicity were observed in the animals during the study. No mortality occurred during the study.
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No symptoms of systemic toxicity were observed in the animals during the study. No mortality occurred during the study..
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the cnditions used in this study, Polycat 9 induced no sensitization. The epidermal exposure to Polycat 9 in the induction phase resulted in severe skin irritation.
Reference
Twelve animals showed a skin reaction in response to the 5% test substance concentration. These reactions were characterised by red spots and scaliness.
None of the animals showed a skin reaction in response the 2% and 1% concentrations.
Taking into account the intensity of the responses and comparing these with the reactions seen in the control animals, no animals showed a positive skin reaction in response to the 5 % concentration.
No symptoms of systemic toxicity were observed in the animals during the study. No mortality occurred during the study.
These results lead to a sensitisation rate of 0 per cent, which indicates that POLYCAT 9 has weak sensitizing properties in this test applying the rating of allergenicity described by Kligman A.M. (1966).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
- Migrated from Short description of key information:
The substance induced no sensitization in A GPMT. The substance is corrosive.
Justification for selection of skin sensitisation endpoint:
Under the conditions used in this study, the substance induced no sensitization. The epidermal exposure to the substance in the induction phase resulted in severe skin irritation.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Not sensitizing in a Guinea Pig Maximisation Test.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)