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EC number: 942-932-9 | CAS number: -
- 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 skin sensitizing potential of the test item was determined in a study according to OECD guideline 406. The test item 45 % in diisobutyl phtalate indicates a sensitisation rate of 50 %.
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:
- 1998-10-19 to 1999-04-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- 1996
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was conducted in 1999 when the GPMT was an internationally accepted and recommended method to assess sensitising properties.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: approx. 4 weeks old
- Weight at study initiation: Individual body weights did not exceed 500 grams
- Housing: Group housing of 5 animals per labelled metal cage with wire-mesh floors and equipped with an automatic drinking system (ITL, Bergen, The Netherlands).
- Diet: Free access to standard guinea pig diet, including ascorbic acid (1600 mg/kg); LC 23-B, pellet diameter 4mm (Hope farms, Woerden, The Netherlands).
- Water: Free access to tap-water, diluted with decalcified water.
- Acclimation period: At least 5 days before the start of treatment under laboratory conditions
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- propylene glycol
- Concentration / amount:
- 2 %
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- propylene glycol
- Concentration / amount:
- 0.5 %
- No. of animals per dose:
- Experimental group: 10 females
Control group: 5 females - Details on study design:
- RANGE FINDING TESTS: Series of test substance concentrations were tested. Practical feasibility of administration determined the highest starting-concentration for each route. The starting- and subsequent concentrations were taken from the series: 100% (undiluted), 50%, 20%, 10%, 5%, 2%, 1% and, if needed, further lower concentrations using the same steps.
MAIN STUDY
A. INDUCTION EXPOSURE (Intradermal and epidermal)
- No. of exposures: 6 intradermal injections (2 injections each of 0.1 mL Freund's adjuvant without the test substance emulsified with water in ratio 1:1; 2 injections 0.1 mL each containg 2 % of the test substance; 2 injections each of 0.1 mL Freund's adjuvant/water (1:1) with test substance). After one week percutaneous induction was carried out (single 48 hours application under occlusive conditions).
- Exposure period: 48 hours
- Test groups: 10 animals
- Control group: 5 animals: Were treated as described for the experimental animals, except that instead of the test substance, vehicle alone was administered.
- Site: clipped flank
- Frequency of applications: 6 simultaneous intradermal injections, one week later, single percutaneous administration
- Duration: one week before percutaneous challenge; 48 hours exposure; ca. 14 days later the first challenge.
- Concentrations: 2 % of test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: On day 21
- Exposure period: 24 hours
- Test groups: 10 animals
- Control group: 5 animals (Treated like test group)
- Site: intact clipped flank
- Concentrations: 0.5 % of test substance
- Evaluation (hr after challenge): 24 h and 48 h after removal of dressing - Challenge controls:
- Challenge control group was treated like test group.
- Positive control substance(s):
- no
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 0.5 %
- No. with + reactions:
- 5
- Total no. in group:
- 10
- Clinical observations:
- scaliness and necrosis
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0.5 %
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Interpretation of results:
- Category 1 (skin sensitising) based on GHS criteria
- Conclusions:
- The skin sensitizing potential of the test item was determined in a study according to OECD guideline 406. The test item 45 % in diisobutyl phtalate indicate a sensitisation rate of 50 %.
- Executive summary:
Assessment for Contact Hypersensitivity to the test item 45% in Diisobutyl Phtalate in the Albino Guinea Pig (Maximisation Test).
The study was carried out based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.6, "Skin Sensitisation" and OECD No. 406, "Skin Sensitisation", and based on the method described by Magnusson and Kligman, "Allergic Contact Dermatitis in the Guinea Pig - Identification of Contact Allergens".
Test substance concentrations selected for the Main study were based on the results of a preliminary study.
In the Main study, ten experimental animals were intradermally injected with a 2% concentration and epidermally exposed to a 2% concentration. Five control animals were similarly treated, but with vehicle alone (propylene glycol). Two weeks after the epidermal application all animals were challenged with a 0.5% test substance concentration and the vehicle.
Skin reactions varying between grades 1 and 3 were observed in nine experimental animals in response to the 0.5% test substance concentration. Skin reactions of grade 1 were observed in two control animals in response to the 0.5% test substance concentration and the vehicle.
Scaliness or signs of necrosis were seen in some treated skin sites among the experimental animals.
The skin reactions grade 1 were considered to be non specific skin reactions. The skin reactions observed in the vehicle treated skin-site in two control animals were unexpected, but were considered to have occurred by accident. Leakage from adjacent treated sites may possibly have occurred. Taking into account the intensity of the responses and comparing these with the skin reactions seen in the control animals, it was considered that hypersensitivity to the test item had been induced in five (of the ten) experimental animals. These results indicate a sensitisation rate of 50 %.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
Assessment for Contact Hypersensitivity to the test item 45% in Diisobutyl Phtalate in the Albino Guinea Pig (Maximisation Test).
The study was carried out based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.6, "Skin Sensitisation" and OECD No. 406, "Skin Sensitisation", and based on the method described by Magnusson and Kligman, "Allergic Contact Dermatitis in the Guinea Pig - Identification of Contact Allergens".
Test substance concentrations selected for the Main study were based on the results of a preliminary study.
In the Main study, ten experimental animals were intradermally injected with a 2% concentration and epidermally exposed to a 2% concentration. Five control animals were similarly treated, but with vehicle alone (propylene glycol). Two weeks after the epidermal application all animals were challenged with a 0.5% test substance concentration and the vehicle.
Skin reactions varying between grades 1 and 3 were observed in nine experimental animals in response to the 0.5% test substance concentration. Skin reactions of grade 1 were observed in two control animals in response to the 0.5% test substance concentration and the vehicle.
Scaliness or signs of necrosis were seen in some treated skin sites among the experimental animals.
The skin reactions grade 1 were considered to be non specific skin reactions. The skin reactions observed in the vehicle treated skin-site in two control animals were unexpected, but were considered to have occurred by accident. Leakage from adjacent treated sites may possibly have occurred. Taking into account the intensity of the responses and comparing these with the skin reactions seen in the control animals, it was considered that hypersensitivity to the test item had been induced in five (of the ten) experimental animals. These results indicate a sensitisation rate of 50 %.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Self-Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the results the substance is considered to be classified as skin sensitizing cat. 1 (H317) under Regulation (EC) No 1272/2008.
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