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EC number: 232-401-3 | CAS number: 8016-11-3
- 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
Two guinea-pig studies of skin sensitisation are available.
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 based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 13 July 1981 to 4 September 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- There is no indication of the number of animals in the control group. There is no indication in the report that the concentration of the test substance used was the highest to cause mild-to-moderate skin irritation. Or that the concentration used for the challenge exposure was the highest non-irritant dose. Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils (linseed, soybean, 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil and epoxidised linseed oil is commonly utilised in the preparation of this dossier and other read-across bridges are used for other members of the EOD group where appropriate.
- Justification for type of information:
- Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils (linseed, soybean, 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil and epoxidised linseed oil is commonly utilised in the preparation of this dossier and other read-across bridges are used for other members of the EOD group where appropriate.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Principles of method if other than guideline:
- The optimisation test was used, an intracutaneous sensitisatopn procedure exceeding the sensitivity of the method recommended in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
- GLP compliance:
- no
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The study was performed prior to the validation and adoption of the LLNA
- Species:
- guinea pig
- Strain:
- other: Pirbright White
- Sex:
- male/female
- Details on test animals and environmental conditions:
- The test was performed on groups of 10 male and 10 female guinea pigs of the Pirbright White Strain, bred on the premise,s and weighing between 400 to 540 grams.
The animals were housed individually in type 3 Macrolon cages, kept at a constant room temperature of 22 ± 2 °C, at a relative humidity of 55 ± 10 % and in a 12 hour light cycle per day.
The animals were fed standard guinea pig pellets - NAFAG, No. 830, Gossau SG, SWitzerland - ad libitum and had ad libitum access to water.
Bodyweights were recorded immediately before initiation of dosing in the inductin phase and at termination of the study. - Route:
- epicutaneous, open
- Vehicle:
- other: propylenglycol 50 % / saline 50 %
- Concentration / amount:
- 0.1 mL of 0.1 % solution of TK 11'278
- Route:
- epicutaneous, open
- Vehicle:
- other: propylenglycol 50 % / saline 50 %
- Concentration / amount:
- 0.1 mL of 0.1 % solution of TK 11'278
- No. of animals per dose:
- 10 male and 10 female
- Details on study design:
- The optimisation test was used, an intracutaneous sensitisation procedure exceeding the sensitivity of the method recommended in the "Appraisal of the Safety of Chemical in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).
During the induction period the animals received injections every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1 % solution of TK 11'278 in propylenglycol 50 % / saline 50 %. One control group was treated with the vehicle alone ("negative control").
On the first day of week 1, two injections of 0.1 mL were administered into the shaven skin of the right flank and on the following days a single intracutaneous injection was given into the flank.
During the second and third week of the induction period the test material was incroporated in a mixture of saline with complete Bacto Adjuvant. (saline : adjuvant = 1:1)
During week 6 a challenge injection of 0.1 mL of a freshly prepared 0.1 % solution of TK 11'278 in propylenglycol 50 % /saline 50 % was administered into the skin of the left flank.
Twenty-four hours after each injection during the first week of the induction period and 24 hours after the challenge injection the reactions were recorded.
The two largest perpendicular diameters (in mm) and the increase in the skin-fold thickness (in mm) were measured and by multiplication of these values the "reaction volume" was obtained (in µL) for each reading from each animal. The mean volume plus one standard deviation of the induction reactions observed in the individual animal in the first week was taken as representing the skin irritation "threshold" for each animal. Any challenge reaction greater than this threshold value in the induction period was graded as an allergenic reaction and the animal termed "positive". The number of "positive" animals in the test group was compared with the number of animals in the control group (treated with the vehicle alone) that showed a non-specific reaction of at least the same magnitude ("negative control").
During week 8 a subirritant dose (30 % TK 11'278 in vaseline) of the test compound was applied epicutaneously under occlusive dressings which were left in place for 24 hours. The skin irritation was recorded according to Draize (described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" 1959 of the US Association of Food and Drug Officials (AFD0) 24 hours after removal of the dressings. For irritation score see table below:
Score for Skin Irritation
Erythema and eschar formation
No erythema........................................................ 0
Very slight erythema (barely perceptible) ...... 1
Well defined erythema ....................................... 2
Moderate to severe erythema .......................... 3
Severe erythema (beed redness) to slight
eschar formation (injuries in depth) ...............4
Total Possible Erythema Score .........................4 - Challenge controls:
- No data
- Positive control substance(s):
- no
- Reading:
- other: after intradermal challenge injection
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: after intradermal challenge injection. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 2.0. Total no. in groups: 20.0.
- Reading:
- other: after occlusive epicutanous application
- Hours after challenge:
- 24
- Group:
- test chemical
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: after occlusive epicutanous application. . Hours after challenge: 24.0. Group: test group. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions employed, no differences between the test group and the vehicle-treated controls were seen. after either intradermal or epidermal challenge application of TK 11'278. According to Regulation (EC) No. 1272/2008, no classification is warranted.
- Executive summary:
Under the experimental conditions employed, no differences between the test group and the vehicle-treated controls were seen. after either intradermal or epidermal challenge application of TK 11'278.
TK 11'278 was found to be deviod of skin-sensitising (contact allergenic) potential in albino guinea pigs. According to Regulation (EC) No. 1272/2008, no classification is warranted.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- supporting study
- Study period:
- 1963
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Very little information provided on the materials and methods of the study. Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils (linseed, soybean, 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil and epoxidised linseed oil is commonly utilised in the preparation of this dossier and other read-across bridges are used for other members of the EOD group where appropriate.
- Justification for type of information:
- Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils (linseed, soybean, 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil and epoxidised linseed oil is commonly utilised in the preparation of this dossier and other read-across bridges are used for other members of the EOD group where appropriate.
- Reason / purpose for cross-reference:
- reference to same study
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- No details of the method stated other than indicating the technique involved 8 intracutaneous injections of 0.1 mL of test material to guinea pigs (3/week on alternate days), followed by a 3 week incubation period then a challenge dose with examinations 24 and 48 hours after challenge. The design was probably similar to Maurer's intracutaneous method.
- GLP compliance:
- no
- Type of study:
- intracutaneous test
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data
- Route:
- intradermal
- Vehicle:
- no data
- Concentration / amount:
- 0.1 mL of the diluted epoxy materials
- Route:
- intradermal
- Vehicle:
- no data
- Concentration / amount:
- 0.1 mL of the diluted epoxy materials
- No. of animals per dose:
- Test group of twenty guinea pigs
- Details on study design:
- Sensitisation of guinea pigs was determined by a technique consisting of eight intracutaneous injections (three per week on alternate days) of 0.1 mL of the diluted epoxy material. A three week incubation period was followed by a challenge dose, and examinations for possible sensitisation reactions were made 24 and 48 hours thereafter.
- Challenge controls:
- No data provided
- Positive control substance(s):
- not specified
- Positive control results:
- No data
- Reading:
- other: 24 and 48 hours post challenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- dose not stated in publication
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: other: 24 and 48 hours post challenge. . Hours after challenge: 24.0. Group: test group. Dose level: dose not stated in publication. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- It was concluded that the test material was not sensitising.
- Executive summary:
Sensitisation of guinea pigs was determined by a technique consisting of eight intracutaneous injections (three per week on alternate days) of 0.1 mL of the diluted epoxy materials. A three week incubation period was followed by a challenge dose, and examinations for possible sensitisation reactions were made 24 and 48 hours thereafter.
It was concluded that the test material was not sensitising. According to Regulation (EC) No. 1272/2008, no classification is warranted.
Referenceopen allclose all
Challenge reactions after occlusive epicutaneous administration of the test material:
Erythema scoer (Draize Score) 24 hours after removal of the dressing: 0
Neither the male or female guinea pigs displayed erythema.
Table 1 Incidence of positive animals per group after intradermal challenge injection
No. of positive animals | ||
No. of treated animals | P | |
Vehicle alone | 2/20 | - |
TK 11'278 | 2/20 |
Table 2 Incidence of positive animals per group after occlusive epicutaneous application
No. of positve animals | ||
No. of treated animals | P | |
Vehicle alone | 0/20 | - |
TK 11'278 | 0/20 |
Table 3 Meand Bodywieghts and Standard Deviation (g)
|
Vehicle control |
TK 11’278 |
||
Male |
Female |
Male |
Female |
|
Pre-test |
502/28 |
450/23 |
493/21 |
472/25 |
End of test |
682/46 |
576/39 |
685/39 |
626/33 |
Mean body weight gain |
180 |
136 |
187 |
154 |
No further information on results
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Read across to a study result from an investigation using a similar material is justified for members of the Epoxidised Oils and Derivatives group. Four epoxidised oils (linseed, soybean, 2-ethylhexyl tallate and fatty acids, C14-C22, 2-ethylhexylesters) have been identified as sharing common structural and functional similarities, recognised in an OECD SIDS review as a single category, and therefore justifying read-across between data for different members of the group. Consequently data sharing between ESBO epoxidised soybean oil and epoxidised linseed oil is commonly utilised in the preparation of this dossier and other read-across bridges are used for other members of the EOD group where appropriate.
ESBO was not found to be sensitising.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
There is no indication of skin sensitisation potential from the studies available. Classification for skin sensitisation under the CLP Regulation is therefore not required.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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