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EC number: 209-754-7 | CAS number: 592-42-7
- 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
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- adopted in 1981
- Deviations:
- yes
- Remarks:
- no data on positive control are available, however the study was conducted according to the guideline at a reputable GLP accredited test facilty subject to standard QA procedures.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The described guinea pig maximisation test according to OECD 406 was conducted in 1991 before the guidance for the LLNA (OECD429, first adopted in 2002) was available, and before the method was fully established and validated. And since the result of the guinea pig maximisation test is considered to be scientifically valid, the test was not repeated also taking into account exposure and animal welfare considerations.
Test material
- Reference substance name:
- Octa-1,7-diene
- EC Number:
- 223-054-9
- EC Name:
- Octa-1,7-diene
- Cas Number:
- 3710-30-3
- Molecular formula:
- C8H14
- IUPAC Name:
- octa-1,7-diene
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White, Dunkin Hartley, BOR DHPW (SPF)
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Fa. Winkelmann, Versuchstierzucht GmbH & Co KG, Borchen, Germany
- Age at study initiation: young adult animals
- Mean weight at study initiation: test group: 354 g; control group 1: 360 g; control group 2: 363 g
- Housing: max. 5 animals/cage (Macrolon type IV)
- Diet: Ssniff G 4 Alleindiaet fuer Meerschweinchen (Fa. Ssniff, Spezialfutter GmbH, Soest, Germany)
- Water: tap water; ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 12 Nov 1990 To: 21 Dec 1990
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- corn oil
- Concentration / amount:
- - Induction, intradermal: 5% (only test group)
- Induction, epicutaneous: 100% (only test group)
- First challenge: 100% (test group and control group 1)
- Second challenge: 25% (test group and control group 2)
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- corn oil
- Concentration / amount:
- - Induction, intradermal: 5% (only test group)
- Induction, epicutaneous: 100% (only test group)
- First challenge: 100% (test group and control group 1)
- Second challenge: 25% (test group and control group 2)
- No. of animals per dose:
- - Test group: 20
- Control group 1: 10
- Control group 2: 10 - Details on study design:
- RANGE FINDING TESTS:
A range finding test was performed in order to determine a test concentration, which is well-tolerated after intradermal induction and to determine a test concentration for epicutaneous induction, which is the highest to cause mild-to-moderate skin irritation. Furthermore, the highest non-irritant dose for epicutaneous challenge was determined within the range finding test:
- Intradermal application: Several concentrations of the test substance in vehicle (0.25%, 0.5%, 1%, 2.5%, 5% and 10% (w/w)) were injected intradermally in the left flank of 2 animals, respectively. Evaluation was performed 24 h post-application. The test substance at a concentration of 10% in vehicle caused moderate edema and erythema formation. Intradermally injections of 0.25 - 5% test substance in vehicle resulted in well defined erythema and moderate edema formation. Thus, a cocentration of 5% was chosen for the intradermal induction.
- Epicutaneous application: Each of 4 animals were treated dermally with test substance concentrations of 2.5%, 25% and 50% (w/w) in vehicle as well as 100% under occlusive conditions for 24 h (two patches on the right and left flank of each animal, respectively). Evaluation was performed directly as well as 24 h and 48 h after patch removal. No primary skin irritation was observed in any animal at any applied dose. Thus 100% was chosen as concentration for dermal induction and challege in the main study. For the dermal induction a pre-treatment with sodium dodecyl sulphate was perfomed in order to create a local irritation.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous, respectively)
- Exposure period: single injection (intradermal) and 48 hours (epicutaneous)
- Test groups:
Intradermal (3 pairs of injections; 0.1 mL/injection):
Injection 1: a 1:1 mixture FCA/water
Injection 2: test substance in vehicle
Injection 3: test substance in a 1:1 mixture FCA/vehicle
Epicutaneous: test substance (2 x 4 cm² patch; occlusive) after pre-treatment with 10% SDS in vaseline 24 h before the epicutaneous induction application
- Control group 1 and 2 (3 pairs of injections; 0.1 mL/injection):
Injection 1: a 1:1 mixture FCA/water
Injection 2: vehicle
Injection 3: a 1:1 mixture FCA/vehicle
Epicutaneous: vehicle (2 x 4 cm² patch; occlusive) after pre-treatment with 10% SDS in vaseline 24 h before the epicutaneous induction application
- Site: shoulder region (shaved area: 4 x 6 cm) for intradermal and epicutaneous induction
- Frequency of applications: every 7 days
- Duration: Days 0-8
- Concentrations: intradermal: 5%, epicutaneous: 100%
B. CHALLENGE EXPOSURE
- No. of exposures: 2 (challenge and rechallenge)
- Day of challenge: 21 (challenge) and 28 (rechallenge)
- Exposure period: 24 h (2 x 2 cm² patch; occlusive)
- Test groups: 0.1 - 0.4 mL test substance (challenge and rechallenge)
- Control group 1: 0.1 - 0.4 mL test substance (only challenge)
- Control group 2: 0.1 - 0.4 mL test substance (only rechallenge)
- Site: left flank for challenge and right flank for rechallenge
- Concentration: 100% (challenge) and 25% (rechallenge)
- Evaluation: 24 h and 48 h after patch removal - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Dose level: Induction: intradermal: 5%, dermal: 100%; Challenge: 100%.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 20
- Total no. in group:
- 20
- Remarks on result:
- other: Dose level: Induction: intradermal: 5%, dermal: 100%; Challenge: 100%.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 9
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- other: Dose level: Induction: intradermal: 0%, dermal: 0%; Challenge: 100%.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Dose level: Induction: intradermal: 5%, dermal: 100%; Challenge: 100%; Rechallenge: 25%.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- other: Dose level: Induction: intradermal: 5%, dermal: 100%; Challenge: 100%; Rechallenge: 25%.
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Dose level: Induction: intradermal: 0%, dermal: 0%; Challenge: 0%; Rechallenge: 25%.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Dose level: Induction: intradermal: 0%, dermal: 0%; Challenge: 0%; Rechallenge: 25%.
- Reading:
- other: not tested
- Hours after challenge:
- 0
- Group:
- positive control
- Dose level:
- not tested
- No. with + reactions:
- 0
- Total no. in group:
- 0
Any other information on results incl. tables
All animals in the test and control groups gained body weight normally until day 28. Thereafter (day 28 - day 31), a slight decrease in body weight was noted in 8 animals of the test group. Furthermore, 8 animals of the test group showed impaired body weight gain. However, since the effects on body weight were also noted in the control animals (14 animals with slightly decreased body weight and 2 animals with impaired body weight gain), it was not considered substance-related.
No systemic effects were noted during the course of the study.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Migrated information
- Conclusions:
- 2/20 animals of the test group and 0/10 animals of the control group showed positive reactions after rechallenge in a guinea pig maximisation test. Thus, classification for skin sensitisation is not warranted.
- Executive summary:
The skin sensitisation potential of 1,7-octadiene was investigated in albino guinea pigs using a Magnusson and Kligman maximisation assay, according to OECD 406. A group of 20 test animals and two control groups with 10 animals each were used. Any effect, especially the formation of erythema, was observed 48 and 72 hours after challenge.
Intracutaneous induction was carried out with 5% test substance in corn germ oil (MEH) on Day 0. Dermal induction was carried out on Day 7 with 100% test substance with pre-treatment of the skin in the injection area with dodecylsulphate sodium salt (10% in Vaseline) 24 hours prior dermal induction (day 6). The first challenge was carried out with 100% test substance on Day 21. Since the animals from control group 1 and the animals in the test group showed light to clear circumscribed skin reactions, a 25% concentration of the test substance in corn germ oil was used for the second challenge on Day 28. The second challenge did not provoke any irritation symptoms in the animals of control group 2. The observed erythema and oedema in the test group must therefore be considered as a sign of an allergic reaction. Positive control data are not reported however the study was reported to follow the OECD guideline and be GLP compliant. The study was conducted according to the guideline at a reputable GLP accredited test facilty subject to standard QA procedures. The test is well conducted and reported, therefore the study is considered to be acceptable and the result can be used for classification purposes.
2/20 animals of the test group and 0/10 animals of the control group showed positive reactions after rechallenge in a guinea pig maximisation test. Thus, classification for skin sensitisation is not warranted.
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