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EC number: 272-905-0 | CAS number: 68919-79-9
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 15, 2015 to August 14, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guideline 406 and EU Method B.6 in compliance with GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- female
- Details on test animals and environmental conditions:
- - Age and weight range (at order): 4 to 5 weeks of age; 250 to 300 grams
- Supplier: Charles River Italia S.p.A., Calco (Lecco), Italy
- Breeder: Charles River France Laboratories, Domaine des Oncins B.P. 0109, F 69592 L’arbresle Cedex, France
- Date of arrival: July 02, 2015
- Weight range at arrival: 251 to 274 grams
- Acclimatisation period: At least 5 d
- Veterinary health check: During acclimatisation period
- Identification: Permanent by tattoo on the ear, following randomisation at arrival
- Animals per cage: Up to 5
- Housing: Noryl cages measuring 74.354.325 cm
- Cage control: Daily inspected and changed as necessary (at least 3 times/week)
- Water: Drinking water supplied to each cage via a water bottle
- Water supply: Ad libitum
- Diet: 8GP17
- Diet supply: Ad libitum throughout the study
- Room lighting: Artificial (fluorescent tubes), daily light/dark cycle of 12/12 h
- Air changes Approximately 15 to 25 air changes/h
- Temperature range: 22°C±2°C
- Relative humidity range: 55%±15% - Route:
- intradermal and epicutaneous
- Vehicle:
- other: Corn oil and 50% v/v emulsion of Freund’s complete adjuvant (FCA) in sterile water
- Concentration / amount:
- Induction by intradermal injection (tolerated by the test system): 0.5% in FCA or corn oil
Induction by topical application: 50% in corn oil
Challenge phase: 20% in corn oil - Route:
- epicutaneous, occlusive
- Vehicle:
- other: Corn oil and 50% v/v emulsion of Freund’s complete adjuvant (FCA) in sterile water
- Concentration / amount:
- Induction by intradermal injection (tolerated by the test system): 0.5% in FCA or corn oil
Induction by topical application: 50% in corn oil
Challenge phase: 20% in corn oil - No. of animals per dose:
- Number of animals in test group: 10
Number of animals in control group: 5 - Details on study design:
- Experimental design
The study was divided into 2 distinct phases. The first of these was a dose-ranging screen which was used to determine suitable dose levels for use in the second phase. This second phase corresponded to the main study: determination of the sensitisation potential of the test substance.
Intradermal injection tolerance test
- Allocation
One group of 2 animals was allocated to the intradermal injection tolerance test.
- Preparation of the site (Day 1)
The hair over the scapulae was removed in the allocated animals using an electric clipper with suitable blade.
- Dosages
Six sites were selected on each animal over the shaved scapulae. Each site was injected with a single concentration of the test substance. Concentrations of 50, 20, 10, 5, 1 and 0.5% in corn oil were selected.
- Dosing method
On Day 1, a single intradermal injection of 0.1 mL of each concentration investigated was administered with a graduated syringe.
- Observations
Observation of the treated sites was performed on Day 2 (approximately 24 h after dosing) and on Day 6 for any signs of reaction to treatment according to the Draize scoring scale below:
Reaction to treatment Value
No erythema 0
Very slight erythema 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema 4
Topical application tolerance test
- Allocation
One group of 5 animals was allocated to the topical application tolerance test.
- Preparation of the site (Day 1)
The hair over the scapulae was removed using an electric clipper with suitable blade. Each animal was then injected intradermally at the prepared site with two injections, each of 0.1 mL, of emulsified Freund’s complete adjuvant.
- Dosing
7 d after the preparation of the test site, the flanks of each animal were clipped free of hair. Each animal was dosed with 2 concentrations of the test substance, 1 on each flank such that a total of 5 concentrations (50, 20, 10, 5 and 1% in corn oil) of the test substance were each dosed in duplicate. A gauze patch measuring 20x20 mm was soaked with 0.2 mL of the test substance and placed onto the selected treatment site. When both sites of the animal had been treated, they were covered with a strip of synthetic film and the trunk wrapped with an elastic adhesive bandage to maintain the test substance in contact with the skin (occlusive barrier).
The adhesive dressings and gauze patches were removed after 24 h contact with the skin and the treated sites gently cleaned by washing with lukewarm water.
- Observations
Approximately 24 and 48 h after removal of the dressings, the treated sites were examined for signs of reaction to treatment.
Scoring scale was according to the following table:
Reaction to treatment Value
No visible change 0
Discrete or patchy erythema 1
Moderate and confluent erythema 2
Intense erythema and swelling 3
Main study - Induction - Intradermal injection
- Allocation
Animals were allocated to treatment to give a test group of 10 animals and a control group of 5 animals.
- Preparation of the site (Day 1)
On the day of dosing (Day 1) the hair over the scapulae was removed over an area of approximately 20x40 mm using an electric clipper with a suitable blade.
- Dosage
Three pairs of intradermal injections were made at the prepared skin site of each animal. All injections were made at the edge of the prepared site and the anterior and median injections were positioned close together and distant from the posterior injections. A volume of 0.1 mL was injected at each site.
- Treatment of the test group
Injection site Treatment
Anterior Emulsified Freund’s complete adjuvant
Median 0.5% test substance in the vehicle (corn oil)
Posterior 0.5% test substance in emulsified Freund’s complete adjuvant
- Treatment of the control group
Injection site Treatment
Anterior Emulsified Freund’s complete adjuvant
Median Vehicle (corn oil)
Posterior Vehicle mixed with emulsified Freund’s complete adjuvant
- Dosing method
The animals were administered by an intradermal injection with a graduated syringe on Day 1.
Observations
Skin reaction at the injection sites was assessed approximately 24 h after injection, according to Draize scoring (described above).
Main study - Induction - Topical application
- Preparation of the site and dosing (Day 8)
7 d after injection (Day 8), the hair was removed on the area surrounding the injection sites by means of an electric clipper. A gauze patch measuring 20x40 mm was soaked with 0.4 mL of the test substance at a concentration of 50% in corn oil or vehicle alone according to the group and then placed over the injection sites. The treatment site was covered with a strip of synthetic film and the trunk wrapped with an elastic adhesive bandage to maintain the test substance in contact with the skin (occlusive barrier).
After a contact period of 48 h, the dressings were removed and the treated sites gently cleaned by washing with lukewarm water.
- Observations
Reaction to treatment was assessed approximately 24 h after removal of the dressings, according to the following table:
Reaction to treatment Value
No visible change 0
Discrete or patchy erythema 1
Moderate and confluent erythema 2
Intense erythema and swelling 3
Main study - Challenge
- Preparation of the site (Day 22)
On Day 22, 3 weeks after preparing the animals for the first induction phase of the main study, all animals were prepared for challenge by clipping the flanks free of hair to expose areas of approximately 50x50 mm on each flank.
- Dosing (Day 22)
A gauze patch measuring 20x20 mm was soaked with 0.2 mL of the test substance at concentration of 20% in corn oil (or vehicle, corn oil) and then placed over the centre of the right (or left) flank. When both sites of the animal had been treated, they were covered with a strip of synthetic film and the trunk wrapped with an elastic adhesive bandage to maintain the test substance and vehicle in contact with the skin (occlusive barrier). After a contact period of 24 h, the dressings and patches were removed and the treated sites were washed with lukewarm water.
- Observations
The treated sites were closely clipped to remove any hair that may have grown approximately 21 h after the removal of the dressings. Observation of the treated sites was carried out approximately 24 and 48 h after removal of the dressings.
The reaction was scored according to the following table:
Reaction to treatment Value
No visible change 0
Discrete or patchy erythema 1
Moderate and confluent erythema 2
Intense erythema and swelling 3 - Positive control substance(s):
- yes
- Remarks:
- α-Hexylcinnamaldehyde tested in separate study
- Positive control results:
- Sensitisation reactions were observed in 60% of the animals. These results are considered to be acceptable for a weak sensitiser like the α-Hexylcinnamaldehyde.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 20% in corn oil (topical exposure)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20% in corn oil (topical exposure). No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 20% in corn oil (topical exposure)
- No. with + reactions:
- 10
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20% in corn oil (topical exposure). No with. + reactions: 10.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- other: control
- Dose level:
- 20% in corn oil (topical exposure)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control. Dose level: 20% in corn oil (topical exposure). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- other: control
- Dose level:
- 20% in corn oil (topical exposure)
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: other: control. Dose level: 20% in corn oil (topical exposure). No with. + reactions: 0.0. Total no. in groups: 5.0.
- Conclusions:
- Under the study conditions, the test substance was considered to be a skin sensitizer.
- Executive summary:
A guinea pig maximization test was conducted to evaluate the skin sensitization potential of the test substance according to OECD Guideline 406 and EU Method B.6, in compliance with GLP.Based on the results of a preliminary study, 0.5 and 50% in corn oil were selected as intradermal and dermal induction doses. The concentration used for challenge application was 20% in corn oil. All of the animals of the test group showed skin reactions 24 and 48 h after challenge exposure.No reaction to the vehicle alone was observed in any animal.Under the study conditions, the test substance was considered to be a skin sensitizer (Salvador M, 2015).
Reference
Preliminary tolerance test
The preliminary tolerance test to establish a suitable concentration for injection in the main sensitisation test indicated that the test substance at a concentration of 0.5% in corn oil was reasonably tolerated. A concentration of 50% was selected for the main topical induction as it was judged to be tolerated by the animals.
Induction
Moderate to severe erythema (score of 3) was seen at the intradermal injection sites following administration of Freund’s complete adjuvant (test and control group, anterior sites), at sites treated with the Freund’s complete adjuvant mixed with 0.5% of the test substance (test group, posterior sites) and at sites treated with the test substance at a concentration of 0.5% in corn oil (test group, median sites). Well defined erythema (score of 2) was seen at sites treated with the Freund’s complete adjuvant mixed with vehicle (control group, posterior sites). None to very slight erythema (scores of 0 and 1) was noted at median sites treated with the vehicle alone (control group). Moderate/confluent to intense erythema and swelling (scores of 2 and 3) were observed following 48 h of topical exposure with the test substance at a concentration of 50% in corn oil (test group). In addition, fissuring of the treated site was observed in test group animals. No erythema was seen in the control group animals. Based on the above results and those seen in the preliminary phase, the test substance at 20% concentration was selected to be used in the challenge phase.
Challenge
Discrete/patchy to intense erythema and swelling (scores ranging from 1 to 3) were observed in all test group animals at the observation performed 24 and 48 h following 24 h topical exposure period to the test substance at 20% concentration in corn oil. No reaction to the vehicle alone was observed in any animal.
Body weight
Body weight changes were not out of the expected range.
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
A guinea pig maximization test was conducted to evaluate the skin sensitization potential of the test substance according to OECD Guideline 406 and EU Method B.6, in compliance with GLP. Based on the results of a preliminary study, 0.5 and 50% in corn oil were selected as intradermal and dermal induction doses. The concentration used for challenge application was 20% in corn oil. All of the animals of the test group showed skin reactions 24 and 48 h after challenge exposure. No reaction to the vehicle alone was observed in any animal. Under the study conditions, the test substance was considered to be a skin sensitizer (Salvador M, 2015).
Migrated from Short description of key information:
Under the study conditions, the test substance was considered to be a skin sensitizer.
Justification for selection of skin sensitisation endpoint:
The study was conducted according to internationally accepted guidelines and in compliance with GLP.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Skin sensitisation
Based on the available guinea pig maximization test, the substance is classified as skin sensitizer Category 1A (H317: May cause an allergic skin reaction) according to CLP (EC 1272/2008).
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