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EC number: 228-536-2 | CAS number: 6290-17-1
- 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
Skin sensitisation (GPMT, OECD 406): not sensitising
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:
- key study
- Study period:
- 17 April 2002 - 18 May 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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:
- 1996
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- At the time it was justified to carry out a GPMT test for regulatory purposes.
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Tierzucht Schonwalde GmbH
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: not specified
- Weight at study initiation: 348-415 g
- Housing: in polycarbonate cages, with two or three animals per cage
- Diet: free access to a pelleted diet, "Altromin 3122"
- Water: free access to bottles with vitamin C enriched domestic quality water acidified to pH 2.5 with Hydrochloric acid in order to prevent microbial growth.
- Acclimation period: 5 days
- Indication of any skin lesions: no
ENVIRONMENTAL CONDITIONS
- Temperature: 21°C ± 3°C
- Humidity: 55% ± 15%
- Air changes (per hr): 10
- Photoperiod (hours dark/hours light): 12/12
- IN-LIFE DATES: not specified - Route:
- intradermal and epicutaneous
- Vehicle:
- peanut oil
- Concentration / amount:
- Intradermal: 0.1 mL 2.5 % (v/v)
Epicutaneous: 0.25 mL 100% (v/v) - Day(s)/duration:
- 20 days
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: ethanol/diethylphthalat 1:1
- Concentration / amount:
- 0.1 mL 100% (v/v)
- Day(s)/duration:
- 14 days
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10
- Details on study design:
- RANGE FINDING TESTS:
- The intradermal irritation of the test article was investigated with two additional animals in order to find the minimal irritant test article concentration for the intradermal induction using intradermal injections as in the main study. Concentrations of 5.0, 2.5, 1.25 and 0.625 %(v/v) were used.
- The topical irritation of the test article was investigated in order to find the minimal irritant test article concentration for the dermal induction, and the maximum nonirritating test article concentration for the challenge application using procedures similar to the main study. Concentrations of 100, 75, 50 and 25 % (v/v) were used.
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: two: intradermal injections and a closed patch topical application
- Exposure period: 6 days after the injections the topical application was given. Exposure period was 48 hours for the topical application
- Test groups: three pairs of intradermal injections (0.1 mL):
1st pair: Freund's complete adjuvant (FCA) mixed 1:1 with sterile distilled water
2nd pair control group (5 animals): peanut oil
2nd pair test item group (5 animals): test item (2.5% (v/v) in peanut oil)
3rd pair control group (5 animals): equal amounts of peanut oil and FCA/sterile distilled water in the ratio 1:1 (v/v)
3rd pair test item group (5 animals): equal amounts of test item (5% in peanut oil) and FCA/sterile distilled water mixed in the ratio 1:1 (v/v).
- Site: shoulder region
B. CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: 14 days after last induction
- Exposure period: 24 hours
- Test groups: one test group consisting of 10 animals
- Control group: one control group consisting of 5 animals
- Site: flank region
- Concentrations: 100% (v/v)
- Evaluation (hr after challenge): 24 and 48 hours after removal of the patches.
RE-CHALLENGE EXPOSURE
- No. of exposures: one
- Day(s) of challenge: 7 days after the challenge
- Exposure period: 24 hours
- Test groups: one test group consisting of 10 animals
- Control group: one control group consisting of 5 animals
- Site: right flank region
- Concentrations: 75% (v/v)
- Evaluation (hr after challenge): 24 and 48 hours after removal of the patches. - Challenge controls:
- A control group of 5 animals was included in the challenge phase.
To confirm the resuits of the challenge a rechallenge in the right flank region was performed one week after the challenge in the same manner, but with a test article concentration of 75 % (v/v). - Positive control substance(s):
- yes
- Remarks:
- α-hexylcinnamaldehyde (23 October 2001-16 November 2001)
- Positive control results:
- 80 % of the animals responded positively in the positive control study
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No abnormalities were observed and bodyweight gain was normal.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities were observed and bodyweight gain was normal.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No abnormalities were observed and bodyweight gain was normal.
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100% (v/v)
- No. with + reactions:
- 2
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities were observed and bodyweight gain was normal.
- Remarks on result:
- other: slight erythema was observed in 2/10 animals
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No abnormalities were observed and bodyweight gain was normal.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities were observed and bodyweight gain was normal.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Clinical observations:
- No abnormalities were observed and bodyweight gain was normal.
- Key result
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 75% (v/v)
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Clinical observations:
- No abnormalities were observed and bodyweight gain was normal.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 85%
- Remarks on result:
- other: see Remark
- Remarks:
- Hexyl cinnamic aldehyde was used as a positive control (16th November 2001). The intradermal induction was 10% and topically 100%. The percentage animals reacting positive was 80%
- Interpretation of results:
- other: Not a skin sensitizer
- Remarks:
- In accordance with EU CLP (EC No. 1272/2008 and its amendments)
- Conclusions:
- Based on the results of a skin sensitisation study with guinea pigs (GPMT), performed according to OECD 406 guideline and under GLP, the substance is considered not to be a skin sensitizer.
- Executive summary:
A guinea pig maximisation test was performed, according to OECD 406 guideline and GLP, to assess the skin sensitising potential of the substance. 15 female guinea pigs, 10 for the test group and 5 for the control group, were used. The study consisted of an induction phase, a challenge phase and a rechallenge phase. In the induction phase (20 days) intradermal injections as well as topical application in the shoulder region were given. For the intradermal injections, a concentration of 2.5 % (v/v) of the substance was used, whereas in the topical application a concentration of 100% (v/v) was used. The irritation in the preliminary test was not presented. In view of the maximum 100% used for topical induction this is considered acceptable. In the challenge phase the substance was only applied occlusively on the skin in the flank region at a concentration of 100% (v/v). Results of the challenge phase showed slight erythema in 2 out of 10 animals in the test group. One week after the challenge phase, a rechallenge phase was carried out in the right flank using a concentration of 75% (v/v) of the substance. No effects were seen in the rechallenge phase. No clinical abnormalities were observed and bodyweight gain was normal during the study.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A guinea pig maximisation test was performed, according to OECD 406 guideline and GLP, to assess the skin sensitising potential of the substance. 15 female guinea pigs, 10 for the test group and 5 for the control group, were used. The study consisted of an induction phase, a challenge phase and a rechallenge phase. In the induction phase (20 days) intradermal injections as well as topical application in the shoulder region were given. For the intradermal injections, a concentration of 2.5 % (v/v) of the substance was used, whereas in the topical application a concentration of 100% (v/v) was used. The irritation in the preliminary test was not presented. In view of the maximum 100% used for topical induction this is considered acceptable. In the challenge phase the substance was only applied occlusively on the skin in the flank region at a concentration of 100% (v/v). Results of the challenge phase showed slight erythema in 2 out of 10 animals in the test group. One week after the challenge phase, a rechallenge phase was carried out in the right flank using a concentration of 75% (v/v) of the substance. No effects were seen in the rechallenge phase. No clinical abnormalities were observed and bodyweight gain was normal during the study.
Justification for classification or non-classification
Based on the results of an in vivo skin sensitisation (GPMT) study, the substance is not classified as skin sensitiser according to EU CLP (EC No. 1272/2008 and its amendments).
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