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EC number: 419-720-5 | CAS number: 182061-89-8
- 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:
- 15 June 1995 to 21 July 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, performed to valid guidelines and the study was conducted under GLP conditions.
- 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
- Type of study:
- guinea pig maximisation test
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male/female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Age at study initiation: approximately 3 months
- Weight at study initiation (mean (standard deviation)): 338 (30) g males; 312 (27) g females
- Housing: individually in polycarbonate cages
- Diet: diet provided ad libitum
- Water: filtered drinking water (0.22 µm), ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 12 cycles per hour of filtered, non-recycled air.
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: From 15 June 1995 to 21 July 1995 - Route:
- intradermal and epicutaneous
- Vehicle:
- other: isotonic saline solution (0.9 % NaCl)
- Concentration / amount:
- Induction
- intradermal: 10 % (w/w) in sterile isotonic saline solution (0.9 % NaCl)
- topical: 10 % (w/w) in sterile isotonic saline solution (0.9 % NaCl)
First challenge:
- topical: 5 % (w/w) in sterile isotonic saline solution (0.9 % NaCl)
Second challenge:
- topical: 1 % (w/w) in sterile isotonic saline solution (0.9 % NaCl) - Route:
- epicutaneous, occlusive
- Vehicle:
- other: isotonic saline solution (0.9 % NaCl)
- Concentration / amount:
- Induction
- intradermal: 10 % (w/w) in sterile isotonic saline solution (0.9 % NaCl)
- topical: 10 % (w/w) in sterile isotonic saline solution (0.9 % NaCl)
First challenge:
- topical: 5 % (w/w) in sterile isotonic saline solution (0.9 % NaCl)
Second challenge:
- topical: 1 % (w/w) in sterile isotonic saline solution (0.9 % NaCl) - No. of animals per dose:
- 5 males and 5 females (control group)
10 males and 10 females (treatment group) - Details on study design:
- RANGE FINDING TESTS
A preliminary study was conducted to inform on test concentrations to be used in the main study. The maximal practicable concentration by both the intradermal, and cutaneous route, was 10 % and this was selected for the main study.
MAIN STUDY
On day 1, an area of 4 cm x 2 cm in the dorsal region between the shoulders was clipped free of fur. Three injections of 0.1 mL were made in this region as follows:
Injection Site Treated group Control group
Anterior 1: FCA diluted at 450 % (v/v) with 0.9% NaCl 1: FCA diluted at 450 % (v/v) with 0.9% NaCl
Middle 2: test material at 10 % (w/w) in vehicle 2: vehicle
Posterior 3: mixture of 50/50 (w/v) of 1 and 2 3: mixture of 50/50 (w/v) of 1 and 2
On day 7, the same region received a topical application of 0.5 mL of sodium laurylsulphate in vaseline (10 % w/w) in order to induce local irritation.
On day 8, the same test site was treated by topical application of 0.5 mL test material at the chosen concentration (treatment group) or the vehicle (control group) and was covered by an occlusive dressing, for 48 hours. On removal of the dressing, any residual test material was removed using a moistened gauze pad.
After a rest period of 12 days, all animals of the treatment and control groups were challenged by a topical application of the test material (0.5 mL) on the right flank. The left flank served as the control and received the vehicle (0.5 mL) only. Test material and vehicle were maintained under an occlusive dressing for 24 hours. On removal of the dressing, any residual test material was removed using a moistened gauze pad. Skin reactions were evaluated approximately 24 and 48 hours after the challenge application according to the scale outlined in the field "Any other information on materials and methods incl. tables", and any other lesions were recorded.
After a rest period of 10 days, a second challenge application was performed under the same experimental conditions. Where the test material and the vehicle were applied to the left and right flanks, respectively. Skin reactions were evaluated approximately 24 and 48 hours after the challenge application and any other skin lesions wee
During the study the animals were observed for clinical signs and mortality twice a day. Individual bodyweights were recorded on study days 1, 8, 15, 25 and on the last day of the study.
At the end of the study, animals were killed. Macroscopic examination of the main organs was performed on the animal found dead during the study. No necropsy on the surviving animals was performed and no skin samples were taken from the challenge application sites. - Challenge controls:
- During the challenge applications the left flank served as a control and was treated topically with the vehicle only (0.5 mL).
- Positive control substance(s):
- yes
- Remarks:
- 2,4-dinitro-1-chlorobenzene
- Positive control results:
- A positive response was observed in 95 % of animals treated with the positive control (1% w/w) during a concurrent study.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: test group. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 1 %
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: rechallenge. . Hours after challenge: 48.0. Group: negative control. Dose level: 1 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the study, no cutaneous reactions, which could be attributable to the sensitisation potential of the test material, were observed. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
- Executive summary:
The skin sensitisation potential of the test material was determined in accordance with standardised guidelines OECD 406 and EU Method B.6 using the Guinea-pig Maximisation Test. The test material was dosed as a 10 % w/w preparation in isotonic saline solution in an intradermal and topical induction phase. Challenge applications were performed topically with a 5 % w/w application made during the first challenge and a 1 % w/w application made during the second challenge. The positive control was shown to have the capacity to cause skin sensitisation confirming the validity of the protocol used for this study. Under the conditions of the study, no cutaneous reactions, which could be attributable to the sensitisation potential of the test material, were observed.
Reference
Clinical examinations
- No clinical signs were observed during the study. In the treated group, one animal was found dead on day 33. Such spontaneous mortality is often observed in guinea-pigs and it was not thought to be related to treatment.
- The body weight gain of the treated animals was normal when compared to the controls.
Scoring cutaneous reactions
- On day 10, after topical application of the induction period, signs of irritation were observed at the test site in the control group. In the treatment group it was not possible to detect signs of dermal irritation due to the test site colouration.
- No cutaneous reactions were observed after both challenge applications. A red colouration of the test site which could mask erythema grade 1 or 2 was noted in all animals after the first challenge application.
- After the second challenge application, a slight colouration which could mask a very slight erythema (grade 1) was observed in 3/10 and 8/19 animals of the control and treated groups, respectively. This was noted at the 24 hour reading only.
Necropsy
- Macroscopic examination of the animal found dead during the study revealed no abnormalities.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitisation potential of the test material was determined in accordance with standardised guidelines OECD 406 and EU Method B.6 using the Guinea-pig Maximisation Test. The test material was dosed as a 10 % w/w preparation in isotonic saline solution in an intradermal and topical induction phase. Challenge applications were performed topically with a 5 % w/w application made during the first challenge and a 1 % w/w application made during the second challenge. The positive control was shown to have the capacity to cause skin sensitisation confirming the validity of the protocol used for this study. Under the conditions of the study, no cutaneous reactions, which could be attributable to the sensitisation potential of the test material, were observed.
The study was performed in line with GLP and accepted standardised guidelines with a high standard of reporting. The study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997) and considered suitable for assessment as an accurate reflection of the test material.
The available data are considered to be complete and the conclusion, not sensitising, was taken forward for risk assessment.
Migrated from Short description of key information:
Not sensitising, male/female Guinea pig, OECD 406, EU Method B.6, de Jouffrey 1995d
Justification for selection of skin sensitisation endpoint:
Only one study is available.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material did not elicit a response in the Guinea pig Maximisation Test and therefore does not meet the criteria for classification as a skin sensitizer.
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