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EC number: 221-453-2 | CAS number: 3101-60-8
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to the O.E.C.D. test guideline no. 429 with GLP compliance.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- not specified
- GLP compliance:
- yes
- Remarks:
- with test substance characterization.
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- The mice were purchased from Harlan Winkelmann GmbH, Borchen, Germany. The animals were housed in Makrolon type I cages in fully air- conditioned rooms in which a central air-conditioning system ensured a temperature in the range of 20—24 °C and a relative humidity in the range of 30—70%. The illumination period was as follows: 12 h light (6.00 a.m.—6.00 p.m.) and 12 h darkness (6.00 p.m.—6.00 a.m.). Tap water and diet was provided ad libitum.
- Vehicle:
- other: Acetone
- Concentration:
- The test substance was applied at concentrations of 0.1, 0.3 and 1.0 % v/v
- No. of animals per dose:
- 6
- Details on study design:
- For the study, groups of 6 female CBA mice were treated with different concentrations of the test substances in acetone or with acetone alone (vehicle control). Twenty five microliter per ear of the respective test substance preparation was applied to the dorsum of both ears for three consecutive days. The control group was treated solely with 25 uL per ear of the vehicle acetone.
Three days after the last application, the mice were injected intravenously (i.v.) with 20 uCi of [3H1-thymidine in 250 uL of sterile saline into a tail vein. About 5 h after the [3H1-thymidine injection, the mice were sacrificed and the auricular lymph nodes on both sides were removed and the weight of each animal’s pooled lymph nodes was determined. Lymph node response was evaluated by measuring the cellular content and [3H]-thymidine incorporation into lymph node cells (indicators of cell proliferation). To this end, single cell suspensions were prepared from the pooled lymph nodes of each animal as soon as possible after dissection by carefully passing the lymph nodes through an iron mesh (mesh size 200 l.tm) into 6 mL of phosphate-buffered physiological saline. Cell Suspensions were washed twice with phosphate buffered saline (PBS) and precipitated with 5% trichloroacetic acid (TCA). Each precipitate was transferred to scintillation fluid and incorporation of [3H}-thymi- dine into the cells was measured in a beta-scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- For cell counts, [3H]-thymidine incorporation and lymph node weights the WILCOXON test was applied.
- Positive control results:
- Positive Control % Concentration Stimulation Index
_________________________________________________________
3 4.56
10 6.63
30 9.86
_________________________________________________________ - Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Test Substance % Concentration Stimulation Index ________________________________________________________ 0.1 1.36 0.3 1.68 1.0 14.2 ________________________________________________________
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: No data presented.
- Interpretation of results:
- sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Authors of the piblication.
- Conclusions:
- Inducing a Stimulation Index of 14.2 at a concentration of 1.0 % v/v the test substance is considered to be a Strong skin sensitiser. The estimated EC3 value is 0.4% v/v.
- Executive summary:
The test substance, p-tert-butylphenyl-1 -(2,3 -epoxy)propyl ether was accessed for skin sensitization potential in an O.E.C.D. test guideline no. 429 LLNA study. Inducing a Stimulation Index of 14.2 at a concentration of 1.0 % v/v the test substance is considered to be a Strong skin sensitiser.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
The test substance, p-tert-butylphenyl-1 -(2,3 -epoxy)propyl ether, was concluded to be a Strong skin sensitiser in both studies. A low EC3 value of 0.4% v/v was reported.
Migrated from Short description of key information:
The test substance was evaluated for skin sensitising potential in two independent O.E.C.D. test guideline 429 mouse LLNA studies.
Justification for selection of skin sensitisation endpoint:
The mouse LLNA study (O.E.C.D. no. 429) reported demonstrated the lower EC3 value.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Based on the positive results of two independent O.E.C.D. test guideline 429 mouse LLNA studies the test substance, p-tert-butylphenyl-1 -(2,3 -epoxy)propyl ether is a CLP Category I Skin Sensitiser, H317, "May cause an allergic skin reaction."
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