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EC number: 251-156-3 | CAS number: 32687-78-8
- 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
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Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 Dec 1988 - 12 Jan 1989
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (adopted 1992)
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Dermatotoxicology, CIBA-GEIGY Limited, 4002 Basel / Switzerland
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Two valid in vivo studies performed with guinea pigs are available. No further LLNA study is required.
Test material
- Reference substance name:
- 2',3-bis[[3-[3,5-di-tert-butyl-4-hydroxyphenyl]propionyl]]propionohydrazide
- EC Number:
- 251-156-3
- EC Name:
- 2',3-bis[[3-[3,5-di-tert-butyl-4-hydroxyphenyl]propionyl]]propionohydrazide
- Cas Number:
- 32687-78-8
- Molecular formula:
- C34H52N2O4
- IUPAC Name:
- 3-(3,5-di-tert-butyl-4-hydroxyphenyl)-N'-[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoyl]propanehydrazide
- Details on test material:
- - Analytical purity: 99.1%
- Physical state: solid, powder
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright white strain (Tif:DHP)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: about 10 weeks old
- Weight at study initiation: 340 - 424 g
- Housing: single housing in Makrolon cages (type 3)
- Diet: standard guinea pig pellets (NAFAG No. 846, Gossau SG), ad libitum
- Water: ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3
- Humidity (%): 30-70
- Photoperiod: 12 hours light cycle
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- other: Sesame oil
- Concentration / amount:
- 1%
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 30%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Vaseline
- Concentration / amount:
- 10%
- No. of animals per dose:
- 10 males and 10 females
- Details on study design:
- RANGE FINDING TESTS:
The following concentrations have been examined on separate animals for the evaluation of the primary irritant potential and the maximum subirritant concentration of test substance: 10 and 30 % of test substance in vaseline. The tested concentrations did not induce erythema reactions. 30 % was, therefore, selected for the epidermal induction application. 10 % was used as subirritant concentration for the challenge application, because highest concentrations may lead to nonspecific reactions in adjuvant treated animals (Magnusson, 1980).
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: single injection (intradermal) and 48 h (epicutaneous)
- Test groups:
First induction
Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea pigs as follows:
- adjuvant and saline (1:1)
- test article in sesame oil
- test article in the adjuvant saline mixture
Second induction
-epicutaneous: test substance (30% in vaseline; 0.4 g paste per patch)
- Control group: A control group was treated with adjuvant and the vehicle during the induction period.
- Site: shaved neck
- Frequency of applications: day 1 (first induction) and day 7 (second induction)
- Duration: day 1-7
- Concentrations: intradermal 1%; epicutaneous 30%
B. CHALLENGE EXPOSURE
- No. of exposures: 1 (epicutaneous)
- Day of challenge: 22
- Exposure period: 24 h
- Test groups: vehicle control and test substance (20 animals)
- Control group: vehicle control (20 animals) and test substance (10 animals)
- Site: flank
- Concentrations: 10% in vaseline (0.2 g paste per patch)
- Evaluation (hr after challenge): 24 and 48 hours
The application sites were pretreated the day before with 10 % sodium lauryl sulfate (open application).
OTHER:
One day before the second induction the application sites were pretreated with 10 % sodium lauryl sulfate (open application). - Challenge controls:
- Control animals were exposed to vaseline and 10% test substance in vaseline at the epicutaneous challenge.
Results and discussion
- Positive control results:
- No positive control was used in this test. Sensitivity of the strain is checked every 6 months with p-phenylenediamine or potassium dichromate.
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions employed, 0% of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings. Thus, the test substance had no skin-sensitizing potential in albino guinea pigs.
- Executive summary:
In a GLP-compliant guinea pig maximization test according to OECD guideline No. 406, 10 male and 10 female animals were first induced and then challenged with the test article to investigate its sensitization potential. Induction was a two-stage operation: First, three pairs of intradermal injections (1 % test substance in sesame oil) were made into the neck of the animals with a 1:1 mixture (v/v) of FCA/ physiological saline, the test substance in sesame oil, and the test substance in a 1:1 mixture (v/v) of FCA/ physiological saline. One week later, 0.4 g of the test article in vaseline at a concentration of 30% was spread onto a filter paper patch (2 x 4 cm) and applied occlusively to the neck of the animals for 48 hours. The application sites were pretreated the day before with 10% sodium lauryl sulfate (open application). Two weeks after the epidermal induction application the animals were tested on the flank with 10% test substance (0.2 g) in vaseline and the vehicle alone for 24 hours. Twenty four hours after removing the dressings the challenge reactions were graded according the Draize scoring scale. An additional 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 control animals were treated with the vehicle as well as with the test compound to control the maximum subirritant concentration. No animal of the test group was sensitized by the test substance; all skin reactions at any time point were scored 0. Therefore, under the experimental conditions of this study, the test material is non-sensitizing when topically applied to albino guinea pigs.
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