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Diss Factsheets
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EC number: 279-632-6 | CAS number: 80939-62-4
- 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
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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:
- 14.06.1982 - 14.07.1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Comparable to guideline study with restrictions (no details on the test substance; no details of the control group; during induction, the test substance was applied on filter patches after an intracutaneous injection of an adjuvant saline mixture; only one reading after challenge at 24 hours).
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- (no details on the test substance; no details on the control group; as first induction step, the test substance was applied on filter patches after an intracutaneous injection of an adjuvant saline mixture; only one reading after challenge at 24 hours)
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- A valid guinea pig study is available peformed before the LLNA protocol was established
- Species:
- guinea pig
- Strain:
- other: Pirbright White Strain
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Ivanovas, Germany
- Age at study initiation: about 10 weeks
- Weight at study initiation: 313-401 g
- Housing: individually in Macrolon cages (type 3)
- Diet (ad libitum): standard guinea pig pellets - NAFAG No. 830
- Water (ad libitum): fresh water, supplemented with fresh carrots
- Acclimation period: 11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 1
- Humidity (%): 50 +/- 1
- Photoperiod (hrs dark / hrs light): 10/14 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: vaseline
- Concentration / amount:
- 10 % of the test substance in vaseline at intradermal/epicutaneous induction; 30 % at challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: vaseline
- Concentration / amount:
- 10 % of the test substance in vaseline at intradermal/epicutaneous induction; 30 % at challenge
- No. of animals per dose:
- 20 animals (10 males/10 females) in the test group, no details concerning the control group
- Details on study design:
- RANGE FINDING TESTS: The concentrations of the test compound for induction and challenge periods were determined on separate animals.
A. MAIN STUDY
Test Group:
First induction week: 0.1 ml of a freshly prepared adjuvant saline mixture was injected intracutaneously at 4 sites on the animal's neck. The test compounds were applied on filter patches (2 x 4 cm) to the epidermis over the injection sites for 24 hours under an occlusive dressing.
Second induction week: The test compound was applied in the same way as during the first week for 48 hours occlusively.
Challenge: After a rest period of 14 days the compound was applied on filter paper patches (2 x 2 cm) to an untreated flank skin of the animals for 24 hours epidermal occlusively.
Twenty four hours after removing the dressings the challenge reactions were graded according to the Draize scoring scale.
Control group:
A control group was treated with adjuvant and the vehicle during the induction period. During the challenge period the group was treated with the vehicle as well as with the test compound to control the maximal subirritant concentration of the test compound in adjuvant treated animals. - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30 %
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- two male animals showed very slight erythema (grade 1); results of the control group were not given
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 30 %. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: two male animals showed very slight erythema (grade 1); results of the control group were not given.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Skin sensitisation
In a Guinea pig mximization study, Pirgbright White guinea pigs (10 male and 10 female animals) were treated with the test substance. Intradermal induction was performed as follows: 0.1 ml of a freshly prepared adjuvant saline mixture was injected intracutaneously at 4 sites on the animal's neck. The test compounds were applied on filter patches (2 x 4 cm, 10% in vaseline) to the epidermis over the injection sites for 24 hours under an occlusive dressing. In the second induction week, the test compound was applied on filter patches (2x2 cm, 10% in vaseline) to an untreated flank skin of the animals for 24 hours epidermal occlusively. Challenge: After a rest period of 14 days the compound was applied on filter paper patches (2 x 2 cm, 30% in vaseline) to an untreated flank skin of the animals for 24 hours epidermal occlusively. 24 hours after removing the dressings the challenge reactions were graded according to the Draize scoring scale: 2 of 20 (10%) showed very slight edema (grade 1) after 24 hours.
Migrated from Short description of key information:
The skin sensitizing potential fo the test susbtance was assessed in a Guinea pig mximization test (Ciba-Geigy, 1982). It was concluded that the test substance does not show a skin sensitizing effect in the Guinea Pig maximization test under the test conditions chosen.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Dangerous Substance Directive (67/548/EEC)
The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for sensitisation is not warranted under Directive 67/548/EEC.
Classification, Labeling, and Packaging Regulation (EC) No. 1272/2008
The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the data, classification for sensitisation is not warranted under 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.
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