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EC number: 407-000-3 | CAS number: 127519-17-9 CGL 384; TINUVIN 384
- 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:
- October 1, 1990 - November 2, 19 90
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-compliant guideline study (OECD)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted May 12, 1981
- GLP compliance:
- yes
- Remarks:
- CIBA-GEIGY Limited Toxicology Services Dermatotoxicology 4002 Basel / Switzerland
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates
- EC Number:
- 407-000-3
- EC Name:
- A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates
- Cas Number:
- 127519-17-9
- Molecular formula:
- C27 H37 N3 O3
- IUPAC Name:
- heptyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate; nonyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate; octyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate
- Details on test material:
- - Physical state: liquid, viscouse
- Analytical purity: 98%
- Storage condition of test material: room temperature
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, Animal Production, 4332 Stein / Switzerland
- Age at study initiation: approx. 10 weeks
- Weight at study initiation: 368 t o 448 g
- Housing: individual in Macrolon cages (Type 3)
- Diet: ad libitum standard guinea pig pellets - NAFAG No. 84 5, Gossau SG
- Water: ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: sesame oil, vaseline
- Concentration / amount:
- Intradermal induction: 5%
Epidermal induction: 100%
Epidermal challenge: 30%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: sesame oil, vaseline
- Concentration / amount:
- Intradermal induction: 5%
Epidermal induction: 100%
Epidermal challenge: 30%
- No. of animals per dose:
- 20 animals in test group
10 animals in control group - Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
The induction was a two-stage operation. First, intradermal injections (into the neck region); second, closed patch exposure over the injection sites one week later. Three pairs of intradermal injections (0.1 ml per injection) were made simultaneously into the shaved neck of the guinea
pigs as follows:
- adjuvant/saline mixture 1:1 (v/v)
- 5% test article in sesame oil (w/v)
- 5% test article in the adjuvant saline mixture (w/v)
In the second week of induction the test material was incorporated in vaseline (w/w) and applied on a filterpaper patch to the neck of the animals (patch 2x4 cm; approx. 0.4 g paste per patch; occluded administration for 48 hours). The application sites were pretreated the day before with 10% sodium lauryl sulfate (open application). During weeks 3 and 4 no treatments were performed. A control group was treated with adjuvant and the vehicle during the induction period.
B. CHALLENGE EXPOSURE
In the fifth week the animals were tested on the flank with 30% test material in vaseline (w/w) and the vehicle alone (patch 2x2 cm; approx. 0.2 g paste per patch; occluded administration for 24 hours). During the challenge period the control group was treated with the vehicle as well as with the test article (at least 10 animals) to check the maximum subirritant concentration of the test article in adjuvant treated animals.
OTHER:
The following concentrations have been examined on separate animals for the evaluation of the primary irritant potential and the maximum subirritant concentration: 100; 30 and 10% of test material in vaseline. The tested concentrations did not induce erythema reactions, under the area of exposure, but on the border when applied as 100 %. 100% was, therefore, selected for the epidermal induction application. 30% was used as subirritant concentration for the challenge application, to omitt all possible nonspecific reactions under the area of exposure and on the borders.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 30%. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- 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: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- 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: 30%. No with. + reactions: 0.0. Total no. in groups: 20.0.
Any other information on results incl. tables
Under the experimental conditions employed, none of the animals of the test group showed skin reactions 24 and 48 hours after removing the dressings.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- No animal of the test group was sensitised by the test article under the experimental condition employed. The test article is therefore classified as not sensitizing in albino guinea pigs.
- Executive summary:
In a 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 (5 % 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, the test article was incorporated in vaseline at a concentration of 100% and applied on a filter paper 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 30% test substance 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 (10 m/10 f) 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 of the test group was sensitized by the test substance, all skin reactions at 24 and 48 hour time points 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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