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EC number: - | 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
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1998/06/30- 1998/09/21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Version / remarks:
- (1992)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Version / remarks:
- (1992)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- Currently no LLNA study is available for assessment. The Buehler test has been carried out as an animal test to predict human sensitization for over a decade and is recommended by international test guidelines such as OECD.
Test material
- Reference substance name:
- Fatty acids, C16-18 and C18-unsatd., epoxidized, Me esters, oligomeric reaction products with trimethylolpropane
- Molecular formula:
- Not applicable (UVCB substance)
- IUPAC Name:
- Fatty acids, C16-18 and C18-unsatd., epoxidized, Me esters, oligomeric reaction products with trimethylolpropane
Constituent 1
- Specific details on test material used for the study:
- - Physical state: clear, colourless, viscous liquid
- Analytical purity: 90 %
- Lot/batch No.: 18009
- Expiration date of the lot/batch: Jan 1999
- Storage condition of test material: room temperature
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Pirbright-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Postfach 11 61, 33178 Borchen, Germany
- Weight at study initiation: male: 380 - 500 g; female: 324 - 438 g
- Housing: The guinea pigs were kept in collective housing up to a maximum of 10 animals per cage in a battery of cages, equipped with a paper disposal system.
- Diet: "Harlan Teklad FD2 Guinea Pig Diet" (pelleted diet) produced by Harlan Teklad, Shaw's farm, Blackthorn Bicester, Oxon, OX6 OTP, England
- Water: community tap water
- Acclimation period: >15 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 3°C
- Humidity: 30 - 70 %
- Air changes: 16/ hour
- Photoperiod: Artificiallight was set to give a cycle of 12 hours light and 12 hours dark with light on at 7.00 a.m.
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG400
- Concentration / amount:
- 100%
- Day(s)/duration:
- 3 exposures/ once a week/ for 6 hours
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG400
- Concentration / amount:
- 25%
- Day(s)/duration:
- Day 14 after last induction/ for 6 hours
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- - total animals: 30
- control animals: 10 (5 males, 5 females)
- test animals: 20 (10 males, 10 females) - Details on study design:
- RANGE FINDING TESTS:
A preliminary test was performed in order to select the concentrations of the test article for the main study. 3 males and 3 females were used in the induction and challenge exposures. The liquid test article was applied undiluted or in concentrations of 75 %, 50 %, 25 % and 10 %, dissolved in PEG, to the clipped skin on the back of each animal using Hill-Top-Chambers (Hill Top, Cincinnati, USA) secured with rubberdental dam (4D Rubber Co., Ltd., UK). In each case, the volume applied was 0.3 mL. The animals were then immobilised in metal restrainers for 6 h, after which time the patches were removed and the animals returned to their cages. Skin reactions were recorded 24 and 48 h after patch removal according to the classification scheme stipulated in the OECD 406.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours until patch removal
- Site: area of clipped skin in the left anterior quadrant of the back of each test animal. Test item exposure occurred always on the same test site.
- Frequency of applications: once a week
- Duration: skin reaction was observed after 24 hours
- Concentrations: undiluted (100 %)
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day of challenge: day 14 after last induction exposure
- Exposure period: 6 hours until patch removal
- Site: area of clipped skin in the right anterior quadrant of the back of each test animal.
- Concentrations: 25 % formulation in PEG400
- Evaluation: 21 hours after patch removal - Positive control substance(s):
- yes
- Remarks:
- alpha-hexyl cinnamic aldehyde
Results and discussion
- Positive control results:
- The sensitivity of the test system and the reliability of the experimental technique is assessed at least every six months by use of "alpha-hexyl cinnamic aldehyde" which is known to induce skin sensitisation in guinea pigs. This test was conducted as a Buehler test according to the OECD 406. The historical control data confirmed the vailidity of the test system and study performance.
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 0%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Clinical observations:
- none
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 50%
- No. with + reactions:
- 6
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 10
Any other information on results incl. tables
No skin reactions were observed after the challenge exposure in test and in control animals at 24 and 48 h after the end of the exposure. Therefore, the sensitisation rate determined at 24 and 48 h was 0 % in each case.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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