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EC number: 412-050-4 | CAS number: 125109-85-5 FLORHYDRAL
- 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
Not skin sensitizer (OECD 406 GPMT, GLP, 1988)
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:
- 1988
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.6 (Skin Sensitisation)
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- Study already available
- Specific details on test material used for the study:
- Batch Number 8906-87
Purity 95.4% - Species:
- guinea pig
- Strain:
- Himalayan
- Remarks:
- Himalayan white spotted guinea pigs (outbred)
- Sex:
- male/female
- Details on test animals and environmental conditions:
- Standard laboratory conditions:
10-15 air changes
22 +/-3 degrees centigrade
40-70% relative humidity
12 hours fluorescent light/12 hours dark
Music/light period - Route:
- intradermal
- Vehicle:
- other: ethanol
- Concentration / amount:
- 0.5%
- Day(s)/duration:
- D1
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Ethanol
- Concentration / amount:
- 50%
- Day(s)/duration:
- One week after the intradermal induction
- Adequacy of induction:
- highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: Ethanol
- Concentration / amount:
- 30%
- Day(s)/duration:
- 2 weeks after the epidermal induction
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 10 animals (5 males and 5 females) for the vehicle control group
20 animals (10 males and 10 females) for the test item-treated group - Positive control substance(s):
- yes
- Remarks:
- A control group is teste twice a year as a sensitivity check of the guinea pig strain. The most recent test at the time was run during March 1988.
- Positive control results:
- 100% of the animal tested were found positive.
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 1
- Total no. in group:
- 19
- Remarks on result:
- other: One positive erythema reaction in one animal at 24 hrs after challenge
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 30%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 30%
- 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: 30%. No with. + reactions: 0.0. Total no. in groups: 5.0.
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- positive control
- Dose level:
- 3% DNCB
- No. with + reactions:
- 15
- Total no. in group:
- 15
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Giv 82-4130 (Florhydral) is considered to possess no skin sensitizing (contact allergenic) potential in albino guinea pigs.
- Executive summary:
A total of 30 male and female outbred Himalayan spotted animals were used. Animals were divided into two groups: test group = 10 males and 10 females; control group = 5 males and 5 females. Animals were 7-8 weeks old and weighed 433-478 grams (males) and 456-499 grams (females). Ethanol was used as a vehicle for the intradermal and epicutaneoues applications. Animals were housed individually in Makrolon type-3 cages. Temperature of the animal room was 22 +/- 3 C with a relative humidity of 40-70% and a 12 hour light/dark cycle, music during the light period. There were 10-15 air changes per hour. Animals received food and water ad libitum. Intradermal injections were made for the first portion of the induction phase of the study. An area of dorsal skin from the scapular region (approximately 6 x 8 cm) was clipped free of hair. Three pairs of intradermal injections (0.1 ml/site) were made at the border of a 4 x 4 cm area in the clipped region as follows: Test group - 1) Freund's complete adjuvant 50:50 with ethanol, 2) test material diluted to 0.5% with ethanol, 3) test material diluted to 0.5% by emulsion in a 50:50 mixture of Freund's complete adjuvant and ethanol; Control group - 1) Freund's complete adjuvant 50:50 with ethanol, 2) Vehicle (ethanol), 3) Freund's complete adjuvant 50:50 with ethanol. On day 7 of the study and approximately 24 hours prior to the epidermal application, the scapular area (approximately 6 x 8 cm) was clipped free of hair. Patches of filter paper (4 x 4 cm) were saturated with 50% test material in ethanol and applied over the injection sites of the test animals. Patches were covered by a strip of aluminum foil and firmly secured by elastic plaster wrapped around the trunk and covered with impervious adhesive tape. Dressings remained in place for approximately 48 hours. The animals of the control group were treated as described above except with the vehicle (ethanol) only. The test and control group animals were challenged 2 weeks after the epidermal induction application. Hair was clipped from a 5 x 5 cm area on the left and right flank of each animal. Two patches (2 x 2 cm) of filter paper were saturated with a) non-irritant concentrations of test material in ethanol, b) with the vehicle only and applied to the a) left flank and b) right flank using the same method as for the epidermal application. The dressings remained in place for 24 hours after which time they were removed. Sites were assessed for erythema and edema immediately, 24, and 48 hours after removal of the dressing, using the following numerical scoring system according to Draize: Erythema and eschar formation: 0 = no erythema, 1 = very slight erythema (barely perceptible), 2 = well-defined erythema, 3 = moderate to severe erythema, 4 = severe erythema (beet redness) to slight eschar formation (injuries in depth); Edema formation: 0 = no edema, 1 = very slight edema (barely perceptible), 2 = slight edema (edges of area well-defined by definite raising), 3 = moderate edema (raised approximately 1 millimeter), 4 = severe edema (raised more than 1 millimeter and extending beyond the area of exposure). The control animals were treated in the same way as the test animals. In addition, observations were made daily for viability/mortality and systemic/local symptoms. Animals were weighed at acclimatization start, start of applicaiton and termination of test. No necropsies were performed
A separate positve control study was conducted with Dinitro-chloro-benzol (DNCB) in Dunkin-Hartley guinea pigs. Induction was 5% DNCB in ethanol and challenge was 3% DNCB in ethanol.
OECD Guidelines for Testing of Chemicals, Section 4: Health Effects No. 406, "Skin Sensitization", adopted May 12, 1981. Directive 84/449, EEC B.6. "Acute Toxicity - Skin Sensitization".
1/20 animals showed positive reations at the 24 hour reading which cleared by the 48 hour reading. Under the conditions of the study, 30% benzenepropanal, .beta.-methyl-3-(1-methylethyl) in ethanol is considered to possess no skin sensitizing potential in guinea pigs. No positive results were observed in the vehicle control group. No second challenge was performed. The positive control 3% DNCB in ethanol showed strong skin sensitizing potential in the guinea pigs.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to the test results available, the substance does not need any classification for skin sensitization under CLP.
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