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EC number: 224-403-8 | CAS number: 4345-03-3
- 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 (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1 April 1996 - 30 April 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: RA study
- Justification for type of information:
- Refer to the section 13 for details on the read across justification.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- according to guideline
- Guideline:
- other: CTFA Guideline for Evaluating Photodermatitis (Photoallergenicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- other: Photoallergenicity test
- Justification for non-LLNA method:
- Presented study was conducted before OECD Guideline 429 was adopted.
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): dl-Alpha-Tocopheryl Acetate
- Physical state: Liquid
- Stability under test conditions: Unknown in ethanol, but stable under storage conditions
- Storage condition of test material: In the original container, at room temperature under nitrogen or argon atmosphere, protected from light - Species:
- guinea pig
- Strain:
- Himalayan
- Remarks:
- spotted (GOHI SPF-quality)
- Sex:
- female
- Route:
- intradermal and epicutaneous
- Vehicle:
- other: ethanol
- Concentration / amount:
- Induction: 100% (undiluted)
- Day(s)/duration:
- 2 weeks
- Adequacy of induction:
- not specified
- No.:
- #20
- Route:
- epicutaneous, open
- Vehicle:
- other: ethanol
- Concentration / amount:
- Challenge: 100% (undiluted), 75%, 50%, and 25%
- Day(s)/duration:
- 72 h
- Adequacy of challenge:
- not specified
- No. of animals per dose:
- Control group: 10, test group: 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- test chemical
- Dose level:
- 100% (undiluted), 75%, 50%, and 25%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 72
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 0
- Key result
- Reading:
- 2nd reading
- Group:
- positive control
- Remarks on result:
- other: not reported
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on the results of the read across study, the test substance does not exhibit photoallergenic potential in the guinea pig.
- Executive summary:
A study was conducted to determine the photoallergenic potential of the read across substance according to the CTFA Safety Testing Guidelines. The photoallergenicity tests were carried out in 30 female (20 test and 10 control) Himalayan spotted guinea pigs. For the induction of sensitization the undiluted test substance was applied epicutaneously to a skin area of 8 cm2 (marked previously with 4 intradermal injections of Freund’s Complete Adjuvant). The test sites were then exposed to 1.8 J/cm2 UVB and 10 J/cm2 UVA irradiation. This procedure was repeated 4 times within 2 weeks of the induction phase. Control animals were treated with FCA only. Three weeks after beginning of the induction a challenge was carried out by treating the experimental animals (test and control) epicutaneously on both flanks with the test substance at 100% (undiluted), 75%, 50% and 25% (dilutions in ethanol). Treated sites were then either exposed to 10 J/cm2 UVA irradiation (left flank) or remained unirradiated (right flank). Cutaneous reactions, i.e. erythema and oedema formation were evaluated at 24, 48 and 72 h after the challenge exposure. 2 out of 20 test animals were observed with a slight erythematous skin reaction after challenge. No consistent or significant differences were detected between the irradiated and non-irradiated test sites of the animals. The reactions were not clearly dependent on the test substance concentration and most likely resulted from cutaneous hyperirritability of the animals. No reactions were observed in the control group. Based on the results of the read across study, the test substance was not found to exhibit photoallergenic potential in the guinea pig (Csato, 1996).
Reference
Induction:
After intradermal induction erythema, oedema, necrotizing dermatitis and exfoliation of encrustation were observed.
After epidermal induction no positive skin reactions were observed.
Challenge:
After challenge two out of 20 animals were observed with a slight erythematous skin reaction after challenge. No consistent or significant differences were detected between the radiated and irradiated test sites of animals. See table below for the results.
No spontaneous deaths occurred, no symptoms of systemic toxicity were observed and the body weight was within the normal range of variability.
Erythema reactions after challenge |
|||||||
|
Concentration (%) |
Left flank (UV-A irradiated) |
Right flank (non-irradiated) |
||||
|
|
% with positive reaction |
% with positive reaction |
||||
|
|
24 hrs |
48 hrs |
72 hrs |
24 hrs |
48 hrs |
72 hrs |
Test group (dl-alpha-tocopheryl acetate, n=20) |
100 |
0 |
0 |
0 |
5 |
5 |
5 |
75 |
5 |
5 |
10 |
10 |
10 |
10 |
|
50 |
5 |
5 |
10 |
5 |
5 |
5 |
|
25 |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control group (n=10) |
100 |
0 |
0 |
0 |
0 |
0 |
0 |
75 |
0 |
0 |
0 |
0 |
0 |
0 |
|
50 |
0 |
0 |
0 |
0 |
0 |
0 |
|
25 |
0 |
0 |
0 |
0 |
0 |
0 |
In only 10% (2 out of 20) test animal slight erythematous skin reactions were observed after challenge. Those reactions were not clearly dependent on the test article concentration and most likely resulted from cutaneous hyperirritability (angry back) of the animals.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A study was conducted to determine the photoallergenic potential of the read across substance according to the CTFA Safety Testing Guidelines. The photoallergenicity tests were carried out in 30 female (20 test and 10 control) Himalayan spotted guinea pigs. For the induction of sensitization the undiluted test substance was applied epicutaneously to a skin area of 8 cm2 (marked previously with 4 intradermal injections of Freund’s Complete Adjuvant). The test sites were then exposed to 1.8 J/cm2 UVB and 10 J/cm2 UVA irradiation. This procedure was repeated 4 times within 2 weeks of the induction phase. Control animals were treated with FCA only. Three weeks after beginning of the induction a challenge was carried out by treating the experimental animals (test and control) epicutaneously on both flanks with the test substance at 100% (undiluted), 75%, 50% and 25% (dilutions in ethanol). Treated sites were then either exposed to 10 J/cm2 UVA irradiation (left flank) or remained unirradiated (right flank). Cutaneous reactions, i.e. erythema and oedema formation were evaluated at 24, 48 and 72 h after the challenge exposure. 2 out of 20 test animals were observed with a slight erythematous skin reaction after challenge. No consistent or significant differences were detected between the irradiated and non-irradiated test sites of the animals. The reactions were not clearly dependent on the test substance concentration and most likely resulted from cutaneous hyperirritability of the animals. No reactions were observed in the control group. Based on the results of the read across study, the test substance was not found to exhibit photoallergenic potential in the guinea pig (Csato, 1996).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available in vivo study with the read across substance, dl-alpha-tocopheryl acetate, indicates that the test substance is not a skin sensitiser. The substance is therefore not classified according to EC (67/548/EEC) and CLP (EC 1272/2008) criteria.
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