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EC number: 247-668-1 | CAS number: 26402-26-6
- 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
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- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
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- Endpoint summary
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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
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
Administrative data
Description of key information
Studies on skin sensitisation of were available for the following Fatty Acid Glycerides category members (CAS No.):
91845-19-1, 620-67-7, 142-18-7, 555-43-1, 73398-61-5.
All available skin sensitisation studies showed that Fatty Acid Glycerides are not skin sensitising.
In silico/ in chemico/ in vitro tests covering skin sensitisation are being performed with the registered substance, octanoic acid, monoester with glycerol. When the new data is available section 7.4 Sensitisation and section 2.1 GHS will be updated accordingly.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Basic data given
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- : group sizes too small; lack of positive control data
- Principles of method if other than guideline:
- According to Buehler, E.V., Arch. Dermat., 91, 171-7 (1965).
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study was performed before REACH inforcement.
- Species:
- guinea pig
- Strain:
- other: Pirbright
- Sex:
- not specified
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Paderborn, Germany.
- Age at study initiation:
- Weight at study initiation: approx. 410 g
- Housing: individually
- Diet (e.g. ad libitum): Ssniff/Intermast
- Water (e.g. ad libitum): yes
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2
- Humidity (%): 45-55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12 - Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 % in Aqua dest.
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- 25 % in Aqua dest.
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
no data
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 10, TS
- Control group: 5, vehicle
- Site: left dorsum
- Frequency of applications: once a week
- Duration: 3 weeks
- Concentrations: 25 %
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after third induction
- Exposure period: 6 hours
- Test groups: 10, TS
- Control group: 5, TS
- Site: right flank
- Concentrations: 25 %
- Evaluation (hr after challenge): 24 and 48 hours after end of challenge exposure
OTHER:
Clinical examination during the study. - Positive control substance(s):
- not specified
- Positive control results:
- No data
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no abnormalities.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no abnormalities.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no abnormalities
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no abnormalities.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- no abnormalities
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no abnormalities.
- Reading:
- other: Reliability
- Group:
- positive control
- Remarks on result:
- other: no data
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Glyceryl Laurate was not sensitising in guinea pig skin.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- May 11th, 1998 - September 10th, 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study was performed before REACH inforcement.
- Species:
- guinea pig
- Strain:
- other: Dunkin-Hartley, Pirbright White Hsd/Poc:DH
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany.
- Age at study initiation: young adults
- Weight at study initiation: less than 500 g
- Housing: conventional in Type IV Makrolon cages, maximum 5 animals per cage
- Diet (e.g. ad libitum): Ssniff G 4 pellet diet, Soest, Germany
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/ 3
- Humidity (%): 30 - 70 (temporary deviations were caused by cleaning the animal room)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 50 % of test substance in vaseline for induction and challenge
(50% of the test substance was found to be the highest concentration which was good miscible in vaseline) - Route:
- epicutaneous, occlusive
- Vehicle:
- petrolatum
- Concentration / amount:
- 50 % of test substance in vaseline for induction and challenge
(50% of the test substance was found to be the highest concentration which was good miscible in vaseline) - No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
3 female animals, 10, 20, 30 and 50 % were applied topically to the flank under occlusive conditions for 6 hours.
The maximum non-irritant concentration of 50% was used for challenge.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: On days 0, 7 and 14
- Test groups: 20, TS
- Control group: 10, vehicle
- Site: left flank
- Frequency of applications:
- Duration: 6 hours
- Concentrations: 50% test substance in vaseline
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 28 (14 days after third induction)
- Exposure period: 6 hours
- Test groups: 20, TS
- Control group: 10, TS
- Site: right flank
- Concentrations: 50% test substance in vaseline
- Evaluation (hr after challenge): 24 and 48 hours after test substance removal with corn oil. - Positive control substance(s):
- yes
- Remarks:
- alpha-hexylcinnamaldehyde
- Positive control results:
- The sensitivity of the guinea pig strain was confirmed by a Buehler test performed from November 24th, 1997 - December 24th, 1997 with alpha-hexylcinnamaldehyde.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 50 % test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no abnormalities
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 50 % test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 50 % test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no abnormalities
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50 % test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 50 % test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 % test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no abnormalities.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 50 % test substance in vaseline
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 % test substance in vaseline. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no abnormalities.
- Reading:
- other: Periodically
- Group:
- positive control
- Remarks on result:
- other: The sensitivity of the guinea pig strain was confirmed by a Buehler test performed from November 24th, 1997 - December 24th, 1997 with alpha-hexylcinnamaldehyde.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- In this study performed according to OECD guideline 406 (Buehler method) Glycerol Tristearate was not sensitising in guinea pigs.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study. No positive control data given.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- , lack of positive control data
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study was performed before REACH inforcement.
- Species:
- guinea pig
- Strain:
- other: Dunkin Hartley, Pirbright White Bor: DHPW
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: young adult
- Weight at study initiation: 401 g +/- 29 g
- Housing: conventional, 5 animals per cage in Makrolon Type IV
- Diet (e.g. ad libitum): Ssniff G4 diet, Soest, Germany
- Water (e.g. ad libitum): tap water, Haltern, Germany
- Acclimation period: > 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 % unchanged test substance for induction and challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100 % unchanged test substance for induction and challenge
- No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
25, 50, 75 and 100 % (w/w) of the test substance in corn oil were tested in 4 animals via topical application under occlusive conditions.
Exposure duration was 6 hours.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 20, TS
- Control group: 10, without TS
- Site: left flank
- Frequency of applications: on days 0, 7 and 14
- Duration: 6 h
- Concentrations: 100 % of the test substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: on day 28 (14 days after the third induction)
- Exposure period: 6 hours
- Test groups: 20, TS
- Control group: 10, TS
- Site: right flank
- Concentrations: 100 % of the test substance
- Evaluation (hr after challenge): 6, 24, 48 and 72 hours after application of the test substance. - Positive control substance(s):
- not specified
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no abnormalities
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no abnormalities
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no abnormalities.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- no abnormalities
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 100 %. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no abnormalities.
- Reading:
- other: periodically
- Group:
- positive control
- Remarks on result:
- other: The sensitivity of the guinea pig strain used to reaction and effect of the known sensitiser 1- chloro-2,4-dinitrobenzene was stated to be checked at regular intervals (no further details provided).
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information In a study performed according to OECD guideline 406 (Buehler), Glycerol Triheptanoate was not sensitising to the skin.
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Insufficient for assessment. Small number of tested animals, only 4% solution in ethanol tested, lack of reporting details.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- small number of tested animals, only 4% solution in ethanol tested, lack of experimental details.
- GLP compliance:
- no
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Study was performed before REACH inforcement.
- Species:
- guinea pig
- Strain:
- other: albino
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 300 ± 50 g - Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 4 % solution
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol
- Concentration / amount:
- 4 % solution
- No. of animals per dose:
- 6
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Site: flank
- Frequency of applications: daily
- Duration:Days 0-9
- Concentrations: 4% solution in ethanol
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 1 challenge
- Test groups: test substance
- Site: flank
- Concentrations: 4% solution in ethanol - Challenge controls:
- No controls
- Positive control substance(s):
- no
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 4% solution in ethanol
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Clinical observations:
- no data
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 4% solution in ethanol. No with. + reactions: 0.0. Total no. in groups: 6.0. Clinical observations: no data.
- Reading:
- other: Reliability
- Group:
- negative control
- Remarks on result:
- other: No Data
- Reading:
- other: Reliability
- Group:
- positive control
- Remarks on result:
- other: No Data
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- November 12th, 1984 - April 18th, 1985
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP - guideline study with acceptable restrictions.
- Qualifier:
- according to guideline
- Guideline:
- other: 79(831/EWG, Annex V, Part B)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- , lack of details on test substance and lack of positive control data.
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study was performed before REACH inforcement.
- Species:
- guinea pig
- Strain:
- other: Pirbright white
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann, Borchen
- Age at study initiation: no data
- Weight at study initiation: mean: 312 g (test group) and 303 (control group)
- Housing: Makrolon Type IV, 5 animals per cage
- Diet (e.g. ad libitum): Altromin Diet 3032 DK, Lage, Germany.
- Water (e.g. ad libitum): tap water
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2
- Humidity (%): 50-60
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light):12/12 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: paraffin oil (1%) for intradermal application and vaseline (50%) for epicutaneous application
- Concentration / amount:
- induction: 50%
challenge: 25 % in vaseline - Route:
- epicutaneous, occlusive
- Vehicle:
- other: paraffin oil (1%) for intradermal application and vaseline (50%) for epicutaneous application
- Concentration / amount:
- induction: 50%
challenge: 25 % in vaseline - No. of animals per dose:
- 20
- Details on study design:
- RANGE FINDING TESTS:
3 preliminary tests were performed with 5 animals each:
For the intradermal induction a 1% concentration of test substance in vaseline induced sufficient skin irritation.
For the epidermal induction a 50% concentration of test substance in vaseline was determined as the minimal irritating concentration.
To be able to determine the maximum non-irritating concentration for challenge treatment, intracutaneous injections of 0.1 mL FCA bilaterally of the vertebral column were made. 2 weeks later 25% and 50% test substance concentrations were applied for 24 h under plaster-covering. A 25% concentration was found to be the maximum non-irritating concentrations.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 2 (intradermal and epicutaneous)
- Exposure period: 2nd induction: 48 h (epicutaneous exposure)
- Test groups: 20 animals, TS (intracutaneously: FCA alone (cranial application), TS in FCA, TS in vehicle, epicutaneously: 1 week after intradermal induction, occlusive conditions)
- Control group: 20, vehicle only
- Site: 1. induction: Interscapular region, 2nd induction on the same site as 1st induction
- Frequency of applications: 1st induction on day 0, 2nd induction on day 7
- Concentrations: 1% for intradermal induction, 50 % for topical induction
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 14 days after the 2nd induction
- Exposure period: 24 hours
- Test groups: 20, TS
- Control group: 20, TS
- Site: right flank, occlusive conditions
- Concentrations: 25 % (0.2 g application volume)
- Evaluation (hr after challenge): 24 and 48 hours after exposure - Positive control substance(s):
- not specified
- Positive control results:
- No data
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities observed.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities observed.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- no abnormalities observed
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no abnormalities observed.
- Reading:
- other: Reliabilty
- Group:
- positive control
- Remarks on result:
- other: no data available
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information to guinea pig skin
Referenceopen allclose all
Individual results were not given in tabulated form, as all skin examination were negative, both at 24 and 48 hours after challenge exposure. None of the animals showed abnormalities in clinical observations and body weight gain.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Glyceride, C16-18- and C18-Hydroxymono- und Di- (CAS No. 91845-19-1) was tested for its skin sensitisation potential according to 79(831/EWG, Annex V, Part B), (Kästner, 1985). 20 Pirbright white guinea pigs were tested in a Guinea pig maximization test and compared with 20 negative control animals. Induction exposure was performed with the test substance at a concentration of 50 % in paraffin oil (1%) for intradermal application and in vaseline (50%) for epicutaneous application. Challenge treatment was performed by dermal application of the test substance at 25 % in vaseline. 24 and 48 hours after challenge exposure all skin examination scores were zero.
2,3-dihydroxypropyl laurate (CAS No. 142-18-7) was tested for its skin sensitisation potential in a Buehler test performed similar to OECD Guideline 406 (Sterner 1977). 10 Pirbright guinea pigs were tested and compared with 5 negative control animals. Three epicutaneous induction exposures were performed with the test substance at a concentration of 25 % in water. Epicutaneous challenge treatment was performed with the test substance at 25 % in water. 24 and 48 hours after challenge exposure all skin examination scores were zero.
Glycerol tristearate (CAS No. 555 -43 -1) was tested for its skin sensitisation potential according to OECD Guideline 406 (Krueger, 1998). The sensitivity of the guinea pig strain was confirmed by a Buehler test performed with alpha-hexylcinnamaldehyde. Twenty Dunkin-Hartley guinea pigs were tested in a Buehler test and compared with ten negative control animals. Three epicutaneous induction exposures were performed with the test substance at a concentration of 50 % in vaseline. Epicutaneous challenge treatment was performed with the test substance at 50 % in vaseline. 24 and 48 hours after challenge exposure all skin examination scores were zero.
Propane-1,2,3-triyl trisheptanoate (CAS No. 620-67-7) was tested for its skin sensitisation potential according to OECD Guideline 406 (Mürmann, 1993). Twenty Dunkin-Hartley guinea pigs were tested in a Buehler test and compared with ten negative control animals. Three epicutaneous induction exposures were performed with the unchanged test substance at a concentration of 100 %. Epicutaneous challenge treatment was performed with the test substance at 100 %. 24 and 48 hours after challenge exposure all skin examination scores were zero. .
Triglycerides, mixed decanoyl and octanoyl (CAS No. 73398-61-5) was tested for its skin sensitisation potential using a Buehler test method (Consultox, 1972). Six guinea pigs were tested in a Buehler test and compared with negative control animals. Ten epicutaneous induction exposures were performed with the test substance at a concentration of 4 % in ethanol. Epicutaneous challenge treatment was performed with the test substance at 4 % in ethanol. No range finding tests were reported. No skin reactions were observed in any of the six tested animals.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria for sensitisation, no classification is required.
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