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EC number: 440-020-0 | CAS number: 61668-40-4
- 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:
- Between 12 October 2001 and 15 November 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols and under GLP conditions.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Five animals w'ere above the weight range specified in the study protocol (450g).
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Supplied by a reputable supplier. For full details please see full study report
- Age at study initiation: Approximately eight to twelve weeks old
- Weight at study initiation: 384 to 499g
- Housing: The animals were housed singly or in pairs in solid-floor polypropylene cages furnished with woodflakes.
- Diet: Free access to food (Certified Guinea Pig Diet (Code 5026
- Water: Free access to mains tap water
ENVIRONMENTAL CONDITIONS
- Temperature: 17 to 23°
- Humidity: 30 to 70%
- Air changes (per hr): At least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): Twelve hours continuous light (06:00 to 18:00) and twelve hours darkness. - Route:
- intradermal and epicutaneous
- Vehicle:
- arachis oil
- Concentration / amount:
- INDUCTION
Intradermal: 5% v/v
Topical: 100%
CHALLENGE CONCENTRATIONS: 100% and 75% v/v - Route:
- epicutaneous, occlusive
- Vehicle:
- arachis oil
- Concentration / amount:
- INDUCTION
Intradermal: 5% v/v
Topical: 100%
CHALLENGE CONCENTRATIONS: 100% and 75% v/v - No. of animals per dose:
- A group of fifteen guinea pigs was used for the main study, ten test and five control
- Details on study design:
- Selection of Concentrations for Main Study (Sighting Tests)
The concentrations of test material to be used at each stage of the main study were determined by 'sighting tests' in which groups of guinea pigs were treated with various concentrations of test material. The procedures were as follows:
Selection of Concentration for Intradermal Induction
Intradermal injections (0.1 ml/injection site) were made on the clipped shoulder of two guinea pigs, using concentrations of 1 % and 5% v/v in arachis oil BP. The degree of erythema at the injection sites was assessed approximately 24, 48, 72 hours and 7 days after injection. The degree of oedema was not evaluated. Any evidence of systemic toxicity was also recorded. The highest concentration that caused only mild to moderate skin irritation, and which was well tolerated systemically, was selected for the intradermal induction stage of the main study.
Selection of Concentration for Topical Induction
Two guinea pigs (intradermally injected with Freund's Complete Adjuvant fourteen days earlier) were treated with the undiluted test material and three preparations of the test material (75%, 50% and 25% v/v in arachis oil BP). Applications were made to the clipped flanks under occlusive dressings for an exposure period of 48 hours. The degree of erythema and oedema was evaluated approximately 1, 24 and 48 hours after dressing removal. The highest concentration producing only mild to moderate dermaI irritation was selected for the topical induction stage of the main study.
Selection of Concentration for Topical Challenge
The undiluted test material and three preparations of the test material (75%, 50% and 25% v/v in arachis oil BP) were applied to the clipped flanks of two guinea pigs under occlusive dressings for an exposure period of 24 hours. These guinea pigs did not form part of the main study but had been treated identically to the control animals of the main study, up to Day 14. The degree of erythema and oedema was evaluated approximately 1, 24 and 48 hours after dressing removal. The highest non-irritant concentration of the test material and one lower concentration were selected for the topical challenge stage of the main study.
Main Study
A group of fifteen guinea pigs was used for the main study, ten test and five control. The bodyweight of each animal was recorded at the start and end of the study.
Two phases were involved in the main study: (a) an induction of a response and (b) a challenge of that response.
Induction
Induction of the Test Animals: Shortly before treatment on Day 0 the hair was removed from an area approximately 40 mm x 60 mm on the shoulder region of each animal with veterinary clippers. A row of three injections (0.1 m) each) was made on each side of the mid-line into a 20 mm x 40 mm area. The injections were:
a) Freund's Complete Adjuvant plus distilled water in the ratio 1:1
b) a 5% v/v formulation of the test material in arachis oil BP
c) a 5% v/v formulation of the test material In a 1 :1 preparation of Freund's Complete Adjuvant plus distilled water.
Approximately 24 and 48 hours after intradermal injection the degree of erythema at the test material injection sites (ie. injection site b) was evaluated.
On Day 7 the same area on the shoulder region used previously for intradermal injections was clipped again and treated with a topical application of the undiluted test material. A filter paper patch (WHATMAN No. 4: approximate size 40 mm x 20 mm), saturated with the undiluted test material was applied to the prepared skin and held in place with a strip of surgical adhesive tape covered with an overlapping length of aluminium foil. The patch and foil were further secured with a strip of elastic adhesive bandage wound in a double layer around the torso of each animal. This occlusive dressing was kept in place for 48 hours.
The degree of erythema and oedema was quantified one and twenty-four hours following removal of the patches.
Any other reactions were also recorded.
Induction of the Control Animals: The intradermal induction was performed using an identical procedure to that used for the test animals except that the test material was omitted from the intradennal injections. Injection b) was therefore the vehicle alone, injection c) was a 50% formulation of the vehicle in a 1:1 preparation of Freund's Complete Adjuvant plus distilled waler. Similarly, the topical induction procedure was identical to that used for the test animals except that the test material was omitted.
Challenge
Shortly before treatment on Day 21, an area of approximately 50 mm x 70 mm on both flanks of each animal, was clipped tree of hair with veterinary clippers.
A square filter paper patch (WHATMAN No. 4: approximate size 20 mm x 20 mm), saturated with the undiluted test material was applied to the shorn right flank of each animal and was held in place with a strip of surgical adhesive tape. To ensure that the maximum non-irritant concentration was used at challenge, the test material at a concentration of 75% v/v in arachis oil BP was similarly applied to a skin site on the left shorn flank. The patches were occluded with an overlapping length of aluminium foil and secured with a strip of elastic adhesive bandage wound in a double layer around the torso of each animal.
After 24 hours, the dressing was carefully removed and discarded. The challenge sites were swabbed with cotton wool soaked in diethyl ether to remove residual material. The position of the treatment sites was identified by using a black indelible marker-pen.
Prior to the 24-hour obsenration the flanks were clipped using veterinary clippers 10 remove regrown hair.
Approximately 24 and 48 hours after challenge dressing removal, the degree of exythema and oedema was quantified.
Any other reactions were also recorded. - Positive control substance(s):
- no
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 75% v/v in arachis oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 75% v/v in arachis oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 47
- Group:
- test chemical
- Dose level:
- 75% v/v in arachis oil
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 47.0. Group: test group. Dose level: 75% v/v in arachis oil. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 10
- Clinical observations:
- 1 animal with score [1]. 1 = Discrete or patchy erythema
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 100%. No with. + reactions: 1.0. Total no. in groups: 10.0. Clinical observations: 1 animal with score [1]. 1 = Discrete or patchy erythema.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- 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: 10.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 75% v/v in arachis oil
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 75% v/v in arachis oil. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 75% v/v in arachis oil
- No. with + reactions:
- 0
- Total no. in group:
- 5
- Remarks on result:
- other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 75% v/v in arachis oil. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- 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: 5.0.
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 5
- 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: 5.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material produced a 0% (0/10) sensitisation rate and was classified as a NON-SENSITISER to guinea pig skin under the conditions of the test.
The test material did not meet the criteria for classification as a sensitiser according to CLP Regulation (EC) 1272/2008 - Executive summary:
A GPMT study according to OECD 406 was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. Ten test and five control animals were used for the study. Two phases were involved in the main study; an induction of a response by intradermal injection and topical application and a topical challenge of that response. Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as: 5% v/v in arachis oil BP for Intradermal Induction, undiluted as supplied for Topical Induction and undiluted as supplied and 75% v/v in arachis oil BP for Topical Challenge. Under the conditions of the test, the test material produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to CLP Regulation (EC) 1272/2008.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A GPMT study according to OECD 406 was performed to assess the contact sensitisation potential of the test material in the albino guinea pig. Ten test and five control animals were used for the study. Two phases were involved in the main study; an induction of a response by intradermal injection and topical application and a topical challenge of that response. Based on the results of sighting tests, the concentrations of test material for the induction and challenge phases were selected as: 5% v/v in arachis oil BP for Intradermal Induction, undiluted as supplied for Topical Induction and undiluted as supplied and 75% v/v in arachis oil BP for Topical Challenge. Under the conditions of the test, the test material produced a 0% (0/10) sensitisation rate and was classified as a non-sensitiser to guinea pig skin. The test material did not meet the criteria for classification as a sensitiser according to CLP Regulation (EC) 1272/2008.
Migrated from Short description of key information:
Skin sensitisation: Not sensitising (Guinea Pig Maximisation Test) OECD TG 406
Justification for selection of skin sensitisation endpoint:
The study result of this study is reliable and adequate for covering this endpoint
Justification for classification or non-classification
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