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EC number: 916-328-0 | CAS number: -
- 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
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- 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
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- Endpoint summary
- Stability
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- 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
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- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Skin sensitation (in vivo): Not sensitising (OECD 406/GLP)
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 19th August 1991 to 14th November 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- May, 1981
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The test was conducted in 1991.
- Specific details on test material used for the study:
- Note: The test reports refers to a substance (CAS No. 67634-00-8) that is typically 71-85% of the multi-constituent substance reaction mass of allyl (2-methylbutoxy)acetate and allyl (3-methylbutoxy)acetate (EC No. 916-328-0). The other component (CAS No. 67634-01-9) is very structurally similar and no difference in toxicity is expected (the ECHA C&L database classifications do not show any new hazards that CAS # 67634-00-8 does not have; checked 11-12-18).
SOURCE OF TEST MATERIAL
- Batch No.of test material:184114
- Expiration date of the lot/batch:October 24, 1991
- Purity:99.3%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: In the original container, protected from light, at room temperature
- Solubility and stability of the test substance in the solvent/vehicle: stable for at least 2 hours in ethanol
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
The test article and vehicle were placed into a glass beaker on a tared Mettler PM 200 balance. A weight/wei~ht dilution was prepared using a homogenizer. Homogeneity of the test art1cle in vehicle (ethanol) was maintained during treatment using a magnetic stirrer. The preparations were made immediately prior to each dosing. - Species:
- guinea pig
- Strain:
- Himalayan
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source:BRL, Biological Research Laboratories Ltd., Wtil ferstrasse 4, CH-4414 Fullinsdorf
- Age at study initiation: 5 weeks
- Weight at study initiation: Control and test group: 305 - 346 g; Pretest: 309 - 341 g
- Housing:Individually in Makrolon type-3 cages with standard softwood bedding ( 11 Lignocel11, Schill AG, CH-4132 Muttenz).
- Diet: Diet Pelleted standard Kliba 342, Batche 63/91 guinea pig breeding/ maintenance diet (11 Kliba 11 , KlingentalmOhle AG, CH-4303 Kaiseraugst), ad libitum
- Water: Community tap water from FOllinsdorf, ad libitum. Once weekly additional supply of ascorbic acid (1 g/1) via the drinking water
- Acclimation period: One week under test conditions after veterinary examination
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 40-70%
- Air changes:10-15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours artificial fluorescent light/12 hours dark - Route:
- intradermal
- Vehicle:
- other: ethanol
- Concentration / amount:
- 5%
- Day(s)/duration:
- 7 days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 100% undiluted
- Day(s)/duration:
- 48 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 30% (posterior left flank)
- Day(s)/duration:
- 24 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No.:
- #2
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 10% (anterior right flank)
- Day(s)/duration:
- 24 hours
- No.:
- #3
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 3% (posterior right flank)
- Day(s)/duration:
- 24 hours
- No. of animals per dose:
- Two females were used for the intracutaneous pretest and 4 females for the epicutaneous pretest.
Ten females for the control group.
20 females for the test group. - Details on study design:
- RANGE FINDING TESTS:
Intradermal injections:
Intradermal injections (0.1 ml/site) were made into the clipped flank of two guinea-pigs at concentrations of 5, 3 and 1% of the test article in ethanol. The resulting dermal reactions were assessed 24 hours later. For intracutaneous induction application a 5% test article dilution was selected (Appendix A).
Epidermal applications:
Patches of filter paper (2 x 2 em) was saturated with the undiluted test article and with concentrations of 30%, 10% and 3% of the test article in ethanol and applied to the clipped and shaved flanks of each of four guinea-pigs. The patches were covered by a strip of aluminum foil and firmly secured by elastic plaster wrapped around the trunk and covered with impervious adhesive tape. This procedure ensured the intensive contact of the test article. The dressings were removed after an exposure period of 24 hours and the reaction sites were assessed 24 and 48 hours after removal of the bandage for erythema and oedema on a numerical basis according to Draize scale.
The allocation of the different test sites on the animals was altenated in order to minimize site to site variation in responsiveness.
MAIN STUDY
Induction
Intradermal injections:
An area of dorsal skin from the scapular region (approximately 6 x 8 em) was clipped free of hair. Three pairs of intradermal injections (0.1 ml/site) were made at the border of a 4 x 6 em area in the clipped region as follows:
Test group:
1) Freund's complete adjuvant 50:50 with physiological saline.
2) The test article, diluted to 5% with ethanol.
3) The test article diluted to 5% by emulsion in a 50:50 mixture of ethanol and Freund's complete adjuvant: physiological saline (1:1).
Control Group:
1) Freund's complete adjuvant 50:50 with physiological saline.
2) ethanol.
3) 50:50 mixture of ethanol and Freund's complete adjuvant: physiological saline (1:1).
Epidermal applications:
One week after the injections, the scapular area (approximately 6 x 8 em) was again clipped and shaved free of hair. A 2 x 4 em patch of filter paper was saturated with the undiluted test article (100 %) and placed over the injection sites of the test animals. The patch was covered by aluminum foil and firm.ly secured by an elastic plaster wrapped around the trunk of the animal and secured with impervious adhesive tape. The dressings were left in place for approximately 48 hours. The epidermal application procedure described ensured intensive contact of the test article. The guinea-pigs of the control group were treated as described above with the
omission of test article (ethanol only). Reaction sites were assessed for erythema and oedema 24 and 48 hours after removal of the dressing, using the numerical grading system according to Oraize.
First Challenge
The test and control guinea-pigs were challenged two weeks after the epidermal induction application. Hair was clipped and shaved from a 5 x 5 em area on the left and right flank of each guinea-pig. Four patches (2 x 2 em) of filter paper were saturated with non-irritant concentrations of 30% (posterior left flank), 10% (anterior right flank), 3% (posterior right flank) and the vehicle only (ethanol, applied to the anterior left flank) using the same method as for the epidermal application. The dressings were removed approximately 24 hours later. The sites were assessed for erythema and oedema 24 and 48 hours after removal of the dressing, using the numerical scoring system according to Draize. The control animals were treated in the same way as described above. Erythema and oedema reactions were described in the tables under Appendix A. - Positive control substance(s):
- yes
- Remarks:
- A positive control group (Formaldehyde-solution) is included for sensitivity check of the guinea pig strain (see Appendix E). The most recent test was run from June 17 to July 1B, 1991 (RCC Project 30347B).
- Positive control results:
- According to the procedures used in this experiment (run from June 17 to July 18, 1991), clear positive results were observed in the (HCHO) treated animals
after the epidermal challenge application. Eight out of 10 animals gave a positive response (Appendix E) - 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:
- no indication of skin sensitisation
- 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:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 10%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 3%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- All dose levels
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- All dose levels
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 15%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 15%
- No. with + reactions:
- 8
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In a guinea pig maximisation test, allyl (3-methylbutoxy) acetate was not sensitising.
- Executive summary:
In a dermal sensitization study (B-158-967) with allyl (3-methylbutoxy) acetate (99.3%) in ethanol, young adult Himalayan female guinea pigs were tested in a maximisation test. For induction, 30% allyl (3-methylbutoxy) acetate in ethanol (intradermal injections) and 100% allyl (3-methylbutoxy) acetate in ethanol (topical application) was used. For challenge, 30, 10 and 3% allyl (3-methylbutoxy) acetate in ethanol was used for topical application. The evaluation of skin reactions after challenge was carried out at 24 and 48 hrs. The positive control was formaldehyde.
The body weight of animals increased during the study and was not affected by the treatment. The positive control, formaldehyde, gave the appropriate response. No deaths occurred. No systemic symptoms were observed in the animals. Application area around the injection sites 1, 2 and 3 was found to show erythema and oedema from day 2 to 6; necroses from day 7 to 11; encrustation from day 12 to 15 and exfoliation from day 16 to 21. No positive reactions were evident after the first challenge application at 24 or 48 hours, neither when treated with ethanol alone nor when treated with the 30%, 10% and 3% test article dilutions.
Based on these results, the substance is not sensitising.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
There is no in vitro skin sensitisation data available. There is one in vivo guinea pig maximisation test available. The test reports refers to a substance (CAS No. 67634-00-8) that is typically 71-85% of the multi-constituent substance reaction mass of allyl (2-methylbutoxy)acetate and allyl (3-methylbutoxy)acetate (EC No. 916-328-0). The other component (CAS No. 67634-01-9) is very structurally similar and no difference in toxicity is expected (the ECHA C&L database classifications do not show any new hazards that CAS # 67634-00-8 does not have; checked 11 -12 -2018).
In a dermal sensitization study (B-158-967) with allyl (3-methylbutoxy) acetate (99.3%) in ethanol, young adult Himalayan female guinea pigs were tested in a maximisation test. For induction, 30% allyl (3-methylbutoxy) acetate in ethanol (intradermal injections) and 100% allyl (3-methylbutoxy) acetate in ethanol (topical application) was used. For challenge, 30, 10 and 3% allyl (3-methylbutoxy) acetate in ethanol was used for topical application. The evaluation of skin reactions after challenge was carried out at 24 and 48 hrs. The positive control was formaldehyde. The body weight of animals increased during the study and was not affected by the treatment. The positive control, formaldehyde, gave the appropriate response. No deaths occurred. No systemic symptoms were observed in the animals. Application area around the injection sites 1, 2 and 3 was found to show erythema and oedema from day 2 to 6; necroses from day 7 to 11; encrustation from day 12 to 15 and exfoliation from day 16 to 21. No positive reactions were evident after the first challenge application at 24 or 48 hours, neither when treated with ethanol alone nor when treated with the 30%, 10% and 3% test article dilutions. Based on these results, the substance is not sensitising.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the available information in the dossier, the substance Allyl Amyl Glycolate (EC No. 916-328-0) does not need to be classified for skin sensitisation when the criteria outlined in Annex I of 1272/2008/EC and Annex I of 286/2011/EC are applied.
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