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EC number: 258-207-9 | CAS number: 52829-07-9
- 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 test substance was devoid of skin sensitizing properties when studied in Guinea Pig maximization tests.
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:
- 21.11.1983 - 22.12.1983
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: - A pilot study was routinely performed in the test laboratory, but results are not reported.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Valid test data with guinea pigs are available, no further studies are required.
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: in-house bred
- Age at study initiation: ca. 10 weeks
- Weight at study initiation: 332-478 g
- Housing: individually in Macrolon cages (type 3)
- Diet: ad libitum standard guinea pig pellets - NAFAG No. 846, Gossau SG - supplemented with fresh carrots.
- Water: ad libitum)
- Acclimation period: 18 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2
- Humidity (%): 50±10
- Photoperiod (hrs dark / hrs light): 10/14 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: sesame oil for intradermal and vaseline for epidermal
- Concentration / amount:
- - Concentrations used for induction: 1% in sesame oil for intradermal and 10% in vaseline for epidermal induction
- Concentrations used for challenge: 1% in vaseline - Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil for intradermal and vaseline for epidermal
- Concentration / amount:
- - Concentrations used for induction: 1% in sesame oil for intradermal and 10% in vaseline for epidermal induction
- Concentrations used for challenge: 1% in vaseline - No. of animals per dose:
- 10/sex
- Details on study design:
- RANGE FINDING TESTS
The concentrations of the test compound for induction and challenge period were determined on separate animals.
MAIN STUDY
A. INDUCTION EXPOSURE
Two intradermal injections (0.1 ml per injection) were made into the neck of the guinea pigs with a mixture of adjuvant and saline, with the test compound in sesame oil and with the test compound in the adjuvant saline mixture. One week later test material was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals (occlusive administration for 48 hours).
- Control group: treated with adjuvant and the vehicle during the induction period
- Concentrations: 1% for intradermal and 10% for epidermal induction
B. CHALLENGE EXPOSURE
Two weeks after the epidermal induction application the animals were tested on the flank with 1% test material in vaseline and the vehicle alone (24 h occlusive application). Twenty four hours after removing the dressings the challenge reactions were graded according the Draize scoring scale. The application sites were chemically depilated 3 hours before examination (Veet, 5 minutes). A second evaluation is made 48 hours after removing the
dressings. During the challenge period
the group was
- Control group: 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.
- Concentrations: 1% - Positive control substance(s):
- yes
- Remarks:
- p-phenylenediamine
- Positive control results:
- The sensitivity of the strain is controlled every six month with p-phenylenediamine, but the results are not reported.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- No animal showed a sensitization reaction (0/20) and the test article is considered as not sensitizing.
Reference
ADDITIONAL RESULTS OF TEST
- Body weight gain: no treatment-related effects
- Clinical signs: none reported
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A guinea pig maximization study was carried out according to the OECD protocol No. 406 Ciba-Geigy, 1984). The test was performed on ten male and then female animals. Two intradermal injections (0.1 ml per injection) were made into the neck of the guinea pigs with a mixture of adjuvant and saline, with the test compound in sesame oil and with the test compound in the adjuvant saline mixture. One week later the test article was incorporated in vaseline and applied on a filterpaper patch to the neck of the animals (occlusive administration for 48 hours). Two weeks after the epidermal induction application the animals were tested on the flank with 1% test material in vaseline and the vehicle alone (24 h occlusive application). Twenty four hours after removing the dressings the challenge reactions were graded according the Draize scoring scale. A second evaluation was made 48 hours after removing the dressings. 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. No animal was sensitized under the experimental conditions employed. Accordingly, the test item is considered to have no dermal sensitization potential. Similar results were reported in two supporting studies.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
There are conclusive but not sufficient data for classification of the test item with regard to sensitization. The test item is not classified for this endpoint in accordance to Directive 67/548/EEC or the CLP Regulation (EC) No 1272/2008 as well as GHS regulations.
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