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EC number: 427-820-5 | CAS number: 2701-50-0 1,2-METHYLEN-4,6-DIENACETAT
- 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:
- July 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- 1992
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- the guinea pig maximisation test was an adequate in vivo skin sensitisation test at the time of performance in 1998 and the adjuvans-method thought to be more sensitive
Test material
- Reference substance name:
- 17-acetoxy-1β,2β-methanopegna-4,6-diene-3,20-dione
- EC Number:
- 427-820-5
- EC Name:
- 17-acetoxy-1β,2β-methanopegna-4,6-diene-3,20-dione
- Cas Number:
- 2701-50-0
- Molecular formula:
- C24H30O4
- IUPAC Name:
- (1S,2S,3R,5S,11R,12S,15R,16S)-15-acetyl-2,16-dimethyl-6-oxopentacyclo[9.7.0.0²,⁸.0³,⁵.0¹²,¹⁶]octadeca-7,9-dien-15-yl acetate
- Test material form:
- solid: bulk
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Strain: Dunkin Hartley Pirbright White guinea-pigs
- Source: Charles River Kislegg
- Age at study initiation: not reported
- Weight at study initiation: males 346-452 g, females 308-387 g
- Housing: 1-2 animals in conventional housing conditions (Makrolon type IV cages)
- Diet and water: ad libitum
- Acclimation period: > 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 64-66
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal and epicutaneous
- Vehicle:
- paraffin oil
- Concentration / amount:
- intradermal induction: 5 % (w/v) test substance
epicutaneous induction: 25 % (w/v) test substance
challenge: 25 % (w/v) test substance
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- paraffin oil
- Concentration / amount:
- intradermal induction: 5 % (w/v) test substance
epicutaneous induction: 25 % (w/v) test substance
challenge: 25 % (w/v) test substance
- No. of animals per dose:
- 10 (5/sex for test and control group)
- Details on study design:
- RANGE FINDING TESTS:
The 5 % (w/v) concentration of the test substance did not produce necrosis and ulcerations in the guinea pigs after intradermal application in
the same region in a previously conducted experiment. The 25 % (w/v) formulation was proved to provoke no necrosis to the skin in a previously performed local tolerance test.
MAIN STUDY
Intradermal induction:
5 male and 5 female guinea pigs (test group) received intracutaneously into the right and left dorsal neck region each 0.1 mL of diluted complete Freund's adjuvant, the test substance at a 5 % (w/v) concentration and the test substance at a 5 % (w/v) concentration mixed with complete Freund' s adjuyant. The control group (5/sex) received in the same way 0.1 mL of diluted Freund's complete adjuvant and the vehicle.
Epicutaneous induction:
On day 8 of the study, the same skin area of both groups was pretreated with sodium lauryl sulphate (10 w/v %) and thereafter on day 9 covered with a filter paper impregnated with the test substance at a 25 % (w/v) concentration in liquid paraffin for the test group, respectively impregnated with liquid paraffin only for the controls. The filter paper was kept under occlusive conditions by a bandage for 48 hours.
Challenge: On day 23, as a challenge, the same procedure was followed as on day 9 but the controls also received the filter paper impregnated with the test substance in liquid paraffin. The application was accomplished in the more sensitive flank region of the same animals. Furthermore, the occiusive bandage remained for only 24 hours. An evaluation of the reactions in the test as weIl as in the control group was carried out on day 25 and 26 of the study (48 and 72 hours after challenge). - Positive control substance(s):
- not specified
- Remarks:
- historical control data with mercaptobenzothiazole available
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Group:
- positive control
- Remarks on result:
- not measured/tested
- Remarks:
- The sensitivity of the used method was proven by performance of a maximization test with mercaptobenzothiazole, a positive reference substance recommended in OECD guideline 406. This reference substance (mercaptobenzothiazole) was tested in Sep./Oct. 1997 in our laboratory. In the test 12 out of 16 animals reacted positively to the challenge with mercaptobenzothiazole.
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Clinical observations:
- slight to moderate reddening
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Reading:
- 1st reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 4
- Total no. in group:
- 10
- Clinical observations:
- slight reddening
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
Any other information on results incl. tables
slight reactions observed in both control and test group are regarded as local intolerance reactions and not as signs of sensitization
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The results of the present study did not give any indication that ZK 5690 has a contact-sensitizing
potential in the guinea-pig in the maximization test. Therefore, ZK 5690 should not be regarded as contact-sensitizer. - Executive summary:
In a preceding local tolerance test, the intracutaneous administration of the recommended maximum concentration of 5.0% (w/v) ZK 5690 was found to be tolerated without severe intolerance reaction. The concentration of 25% (w/v) ZK 5690 was tolerated epidermally without local findings. Therefore, these concentrations were chosen for induction and challenge.
5 male and 5 female Dunkin Hartley Pirbright White guinea-pigs (test group) each received intracutaneously 0.1 ml of diluted Freund's complete adjuvant (FCA), ZK 5690 [5.0% (w/v)] and ZK 5690 [10.0% (w/v)] diluted 1 + 1 with FCA. In the same way, the control group (5M, 5F) received 0.1 ml of the vehicle [0.9% (w/v) NaCI in aqua bidest.] with and without FCA.24 hours after the end of exposure, 8 out of 10 animals of the control group and 4 out of 10 animals in the test group showed slight local skin reactions in form of slight to moderate reddening, which was no longer observed 48 hours after end of exposure. Due to the higher incidence in the control group, the skin reactions are regarded as local intolerance reactions indicative of FCA lowering the local tolerance threshold and not as signs of a sensitizing potential of the compound. Because of the low incidence, the low severity and short duration of the findings in the test group, it. has not to be expected that the local intolerance reactions may have masked possible contact-sensitizing effects of the compound.
Therefore, the present maximization test is regarded as valid for estimation of the skin sensitizing potential of ZK 5690 which is not a skin sensitizer.
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