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EC number: 229-554-3 | CAS number: 6607-34-7
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May 15 - June 8, 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD), GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- July 17, 1992
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2600 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japan; MAFF
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Department of Toxicology, BASF AG
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- 1,4,7 Trioxacylotridecane - 8, 13 dione
- IUPAC Name:
- 1,4,7 Trioxacylotridecane - 8, 13 dione
- Reference substance name:
- 2,3,7,8-tetrahydro-2,5,8-benzotrioxacycloundecine-1,9-dione
- EC Number:
- 229-554-3
- EC Name:
- 2,3,7,8-tetrahydro-2,5,8-benzotrioxacycloundecine-1,9-dione
- Cas Number:
- 6607-34-7
- Molecular formula:
- C10H16O5
- IUPAC Name:
- 1,4,7-Trioxacyclotridecane-8,13-dione
- Details on test material:
- - Name as cited in report: Adipic acid, cyclic ester with diethyleneglycol
- Analytical purity: ca. 90%
- Physical state: Solid/white
- Storage: Refrigerated
- Lot/batch No.: B 74
- Stability: The test substance was stable in 0 .5% Tylose CB 30.000 in aqua bidest for a time period of 4 hours.
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Hsd Poc: DH (SPF)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, FRG
- Age at study initiation: young adults
- Weight range at study initiation: 327 - 360 g
- Housing: 5 per cage
- Diet: ad libitum, Kliba Labordiaet (Kaninchen-Meerschweinchen-Haltungsdiaet). The feed was assayed for chemical and microbiological contaminants.
- Water: ad libitum, tap water (drinking water is regularly assayed for chemical and micriobilogical contaminants)
- Acclimation period: 6 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25
- 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: 1% Tylose CB 30.000 (cleaned sodium carboxymethylcellulose from Hoechst AG) in aqua bidest
- Concentration / amount:
- - Pretest intradermal induction: 5% in Freund's adjuvant/ 0.9 / aqueous NaCl (1:1) or in 1% Tylose CB 30.000 in aqua bidest.
- Pretest epicutaneous induction: 10% and 25% test substance in 1% Tylose CB 30.000 in aqua bidest.
MAIN TEST:
Intradermal induction: test substance 5% in 1% Tylose CB 30.000 in aqua bidest. or 5% in Freund's adjuvant /0.9% aqueous NaCI solution (1:1).
Epicutaneous induction: 25% test substance 1% Tylose CB 30.000 in aqua bidest.
Challenge: 25% test substance 1% Tylose CB 30.000 in aqua bidest.
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 1% Tylose CB 30.000 (cleaned sodium carboxymethylcellulose from Hoechst AG) in aqua bidest
- Concentration / amount:
- - Pretest intradermal induction: 5% in Freund's adjuvant/ 0.9 / aqueous NaCl (1:1) or in 1% Tylose CB 30.000 in aqua bidest.
- Pretest epicutaneous induction: 10% and 25% test substance in 1% Tylose CB 30.000 in aqua bidest.
MAIN TEST:
Intradermal induction: test substance 5% in 1% Tylose CB 30.000 in aqua bidest. or 5% in Freund's adjuvant /0.9% aqueous NaCI solution (1:1).
Epicutaneous induction: 25% test substance 1% Tylose CB 30.000 in aqua bidest.
Challenge: 25% test substance 1% Tylose CB 30.000 in aqua bidest.
- No. of animals per dose:
- PRETEST:
Intradermal pretest: 2 animals
Epicutaneous pretest: 5 animals
MAIN TEST.
Control group 1: 5
Control group 2: 5
Test group: 10 - Details on study design:
- PRETEST: INTRADERMAL INDUCTION
The pretest was used to determine the concentrations for the test substance suitable for use in the main experiment. 6 intradermal injections (per animal) in groups of two per animal were applied to the clipped shoulder of each animal (2 animals/dose). 24 h after injection, a reading of dermal response was performed.
- front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCI-solution in a ratio of 1 : 1.
- middle row: 2 injections each of 0.1 ml of a test substance formulation in an appropriate vehicle at the selected concentration.
- back row. 2 injections each of 0.1 ml Freund's adjuvant/ 0.9% aqueous NaCI-solution (1 : 1) with test substance at the selected concentration.
PRETEST: EPICUTANEOUS INDUCTION.
For detecting a possible influence on irritating effects of previous intradermal treatment with Freund's adjuvant, animals pretreated with Freunds's adjuvant 4 weeks prior to substance application were employed. The epicutaneous pretest was performed by applying 2 x 2 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing 0.5 ml of the test substance formulation to the skin of the flanks under an occlusive dressing. The test substance was applied 2 times for 24 hours within a period of 96 hours in order to detect non-specific phenomena that are not caused by a sensitization reaction but could possibly be attributed to a shift in the irritation threshold. Readings were performed 24 h and 48 h after the beginning of application.
MAIN STUDY: INDUCTION EXPOSURE
6 intradermal injections in groups of two per animal were given on the clipped shoulders of the test animals. Skin responses were checked 24 h after the application of the intradermal injections. Injection of the test group was identical to the intradermal pretest (see above).
The animals of the control groups were used to rule out a substance induced primary skin irritation. A second control group (control group 2) was added for potential second challenge in case of borderline results at the first challenge. Control group 1 cannot be used in this case due to a possible sensitization by the single application of the test substance at the first challenge .
Injection pattern for control groups:
- front row: 2 injections each of 0.1 ml Freund's adjuvant without test substance emulsified with 0.9% aqueous NaCI-solution in a ratio of 1 : 1.
- middle row: 2 injections each of 0.1 ml of the undiluted vehicle
- back row. 2 injections each of 0.1 ml of a 50% formulation of the vehicle without test substance emulsified with Freund's adjuvant/ 0.9% aqueous NaCI-solution (1 : 1 )
One week after the intradermal injections, the epicutaneous induction was carried out by applying 2 x 4 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co. KG) containing 1 ml of the test substance formulation to the skin of the shoulder (same area as in the case of the previous intradermal application) of each animal under occlusive dressing. The patches were removed after 48 h, the skins were washed with water and the skin was assessed.
B. CHALLENGE EXPOSURE
The challenge exposure was performed 14 days after the epicutaneous induction. 2 x 2 cm gauze patches (6 layers surgical gauze Ph. Eur. from Lohmann GmbH & Co . KG) containing 0.5 ml of the test substance formulation were applied to the skin of the intact flank of each animal under an occlusive dressing. The test group and control group 1 were treated with the test substance formulation. Additionally, 1% Tylose CB 30 .000 in aqua bidest. was applied as a vehicle control. Control group 2 only were treated with only the vehicle. The exposure lasted 24 hours. The skins were washed with water upon removal of the patch and checked for dermal response 24 and 48 h after removal of the patch.
OTHER:
Weight check of the individual animals was performed at the beginning of the study (day 0) and at the end of the study (last day of observation). Clipping of the test animals was carried out at least 2 hours before each test substance application at the appropriate application sites. A check for dead or moribund animals was made twice each workday and once on Saturdays, Sundays and on public holidays.
The number of animals with skin findings at 24 and/or 48 hours after the removal of the patch is taken into account for the determination of the sensitization rate. The evaluatio "sensitizing" results if 30% of the test animals exhibit skin reactions in the adjuvant test. - Positive control substance(s):
- no
- Remarks:
- - However, separate studies performed in the lab. including the positive control substance, alpha-hexylcinnamaldehyde, indicated that the test system was able to detect sensitizing compounds under the laboratory conditions chosen.
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Control group 1
- Dose level:
- 25% Test substance in 1% Tylose CB 30.000 in aqua bidest.
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Control group 1. Dose level: 25% Test substance in 1% Tylose CB 30.000 in aqua bidest.. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Control group 1
- Dose level:
- 25% Test substance in 1% Tylose CB 30.000 in aqua bidest.
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Control group 1. Dose level: 25% Test substance in 1% Tylose CB 30.000 in aqua bidest.. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25% Test substance in 1% Tylose CB 30.000 in aqua bidest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25% Test substance in 1% Tylose CB 30.000 in aqua bidest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25% Test substance in 1% Tylose CB 30.000 in aqua bidest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25% Test substance in 1% Tylose CB 30.000 in aqua bidest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Control group 1
- Dose level:
- 1% Tylose CB 30.000 in aqua bidest.
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Control group 1. Dose level: 1% Tylose CB 30.000 in aqua bidest.. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Control group 1
- Dose level:
- 1% Tylose CB 30.000 in aqua bidest.
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Control group 1. Dose level: 1% Tylose CB 30.000 in aqua bidest.. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 1% Tylose CB 30 .000 in aqua bidest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% Tylose CB 30 .000 in aqua bidest. . No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1% Tylose CB 30.000 in aqua bidest.
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% Tylose CB 30.000 in aqua bidest.. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: Control group 2
- Dose level:
- 1% Tylose CB 30 .000 in aqua bidest.
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: Control group 2. Dose level: 1% Tylose CB 30 .000 in aqua bidest. . No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: Control group 2
- Dose level:
- 1% Tylose CB 30 .000 in aqua bidest.
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: Control group 2. Dose level: 1% Tylose CB 30 .000 in aqua bidest. . No with. + reactions: 0.0. Total no. in groups: 5.0.
Any other information on results incl. tables
Comments to Maximization test in Guinea pig
Control group 2 had been intended for a potential 2nd challenge. This group was not treated with the test substance, since a 2nd challenge was not necessary on the basis of the unambiguous results of the challenge.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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