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EC number: 203-562-7 | CAS number: 108-22-5
- 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:
- 1995-05-29 to 1995-07-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: OECD guideline study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
Test material
- Reference substance name:
- Isopropenyl acetate
- EC Number:
- 203-562-7
- EC Name:
- Isopropenyl acetate
- Cas Number:
- 108-22-5
- Molecular formula:
- C5H8O2
- IUPAC Name:
- isopropenyl acetate
- Details on test material:
- Name: Isopropenylacetate
Supplied by: Wacker-Chemie GmbH, Johannes-HeB-StraBe 24, D-84489 Burghausen
Chemical name: 1-Propen-2-ol, acetate
Physical state: clear watery liquid
Identification: labelled, where appropriate, with name of test article, batch no., name of sponsor, project no., date of receipt, storage conditions, handling precautions and ex-piry date
Storage: ambient, protected from light
Expiry date : September 3, 1995
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Species:guinea pig
Strain:Pirbright white
Substrain:HsdlWin: DH
Source:Harlan-Winkelmann GmbH, Postfach 11 61, Gartenstr. 27, D-33178 Borchen
Date of receipt:April 12, 1995 (range finding), May 24, 1995 (main test)
Acclimatization period:46 days (range finding), 14 days (main test)
Animal selection: random
Animal identification: with colored markings; cage labelled with sex, date of study initiation, project no.
Weight range (main test): male: 344 - 439 g, female : 346 - 402 g
Housing: collective housing up to a maximum of 5 animals per cage (Makrolon® type IV)
Illumination: artificial lighting (120 lux) from 7.00 a.m. - 7.00 p.m.
Temperature: 22±3° C
Relative humidity: 30 -70 %
Measurement: twice daily
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- peanut oil
- Concentration / amount:
- 5%
Challengeopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- peanut oil
- Concentration / amount:
- 5%
- No. of animals per dose:
- 10 male/female
- Details on study design:
- Intradermal Injection: The test article was diluted with aqua ad iniect. and Freund's complete adjuvant to give a final concentration of 5 %. Two animals were employed, skin reactions being recorded 48 h after treatment.
Dermal Application: The test article was used undiluted. A closed patch exposure was effected by means of an occlusive bandage using Hill-Top Chambers and non-irritating tape Elastoplast, which enveloped the whole of the animal's trunk. Two animals were employed and skin reactions were recorded 48 h post applicationem.
Main study: The main study was performed on 20 test and 10 control animals. On the basis of the results of the range finding the concentration of 5 % of the test article was considered to be suitable for intradermal injection and the concentration of 100 % for dermal application
Induction Procedure: First stage - an area of 4 x 6 cm over the shoulders was clipped short with electric clippers and cleaned with 70 % (v/v) ethanol. Three pairs of intradermal injections were then made symmetrically in two rows on either side of the spine:
Test group:
1. 0.1 ml FCA 50 % (w/w) diluted in aqua ad iniect.
2. 0.1 ml test article diluted in peanut oil (final concentration: 5 %)
3. 0.1 ml test article diluted in FCNaqua ad iniect. (final concentration: 5 %)
Control group:
1.0.1 ml FCA 50 % (w/w) diluted in aqua ad iniect.
2. 0.1 ml peanut oil
3.0.1 ml peanut oil 50 % (w/w) diluted in FCA
Second stage - 7 days after the intradermal injections, dermal application was initiated. At the maximum concentration in the pilot study, the test article was non-irritating. Therefore after reclipping, the area was pretreated with 10 % sodium lauryl sulfate (SLS) in vaseline 24 h before application of the test article to induce a mild inflammation. The test article (at a concentration of 100 %) was spread in a thick layer [to saturation] over a 4 x 5 cm patch (filter paper). The latter was firmly secured over the previous injection sites by an occlusive dressing for 48 h. Control animals received a patch loaded with peanut oil.
Challenge procedure: Both control and test animals were subjected to a challenge exposure 14 days after the second stage of induction. The challenge test was performed on a 5 x 5 cm clipped area on each flank of the animals. The maximal non-irritating concentration of the test article (lOO %) was
applied to the left flank and peanut oil to the right in a volume of 0.5 ml using the patch technique described under 4.3.2. In each case the duration of exposure was 24 h under an occlusive dressing. 24 and 48 h after patch removal, the treated skin areas were evaluated on a numerical scale according to Draize. - Challenge controls:
- The reaction to the positive control substance 2,4 dinitrochlorobenzene is tested periodically. The last test with acceptable levels of responses to this substance (mild or moderate sensitizer in dependence on the concentration) was performed from December 16, 1994 till January 9, 1995.
- Positive control substance(s):
- yes
- Remarks:
- 2,4 dinitrochlorobenzene
Results and discussion
- Positive control results:
- The positive control substance worked as expected.
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:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 5%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.01%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- slight oedema and erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.01%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: slight oedema and erythema.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Clinical observations:
- slight oedema and erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 6.0. Total no. in groups: 10.0. Clinical observations: slight oedema and erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.01%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.01%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: none.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 0.1%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- slight oedema and erythema
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: positive control. Dose level: 0.1%. No with. + reactions: 2.0. Total no. in groups: 10.0. Clinical observations: slight oedema and erythema.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- Isopropenyl acetate did not cause skin sensitizing effects under the conditions of the test performed.
- Executive summary:
The skin sensitization potential of Isopropenyl acetate (99.5% pure) was assessed in 10 male and female Pirbright White Hsd/Win:DH guinea pigs using the Magnusson and Kligman maximization test in accordance with OECD Guideline 406. Intradermal induction was accomplished with 5% dilution in peanut oil and with a 5% dilution of the test item in water and Freund’s complete adjuvans. A week after the intradermal induction, the skin was pretreated with 10% sodium lauryl sulphate in petrolatum in order to cause mild irritation 24 hours prior to dermal induction by means of a 48 hour occlusive application of the undiluted test compound. Dermal challenge with undiluted test item through 24 h occlusive application, carried out two weeks after the second induction treatment, elicited no positive skin reactions in any of the guinea pigs treated. Therefore Isopropenyl acetate did not cause skin sensitizing effects under the conditions of this test.
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