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EC number: 619-290-0 | CAS number: 97780-06-8
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 97780-06-8
- Test material form:
- solid
- Details on test material:
- -Purity: 96.8%
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Buckshire Corporation, Perkasie, Pennsylvania
- Age at study initiation: Young adult
- Weight at study initiation: 2390-2964 g
- Housing: The rabbits were housed singly in suspended, stainless steel, wire-mesh cages
- Diet (e.g. ad libitum): Purina Certified Rabbit Chow® #5322
- Water (e.g. ad libitum): No details are available on the source of the water
- Acclimation period: 2 weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 2°C
- Humidity (%): 50% ± 10%
- Air changes (per hr): No information is available
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: Shaved and abraded on the left side and shaved and intact of the right side of the rabbit
- Vehicle:
- other: Dimethyl phthalate to moisten the test substance
- Controls:
- no
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g moistened with dimethyl phthalate - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 1 male and 5 females
- Details on study design:
- TEST SITE
- Area of exposure: scapular to the lumbar region of the back
- Type of wrap if used: 1-inch gauze square that was held in place with non-irritating tape; Rubber sheeting was then wrapped around the animal and secured with clips to retard evaporation and to keep the test material in contact with the skin without undue pressure
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The test sites were gently washed with paper towels and warm water to remove excess test material and gently wiped dry
- Time after start of exposure: 24 hours
OBSERVATION TIME POINTS
24, 48, and 72 hours following the application of the test material
SCORING SYSTEM:
- Method of calculation: The numerical values corresponding to each animal for erythema and edema were recorded at each observation period. Mean group scores were calculated for each dermal response (erythema and edema) by summing the scores obtained from all intact sites at the 24-, 48-, and 72-hour observations. The 3 means corresponding to the 3 observation periods were averaged and Overall Averages were obtained for each dermal lesion.
In addition, for each of 6 rabbits, the values for both dermal lesions at 24, 48, and 72 hours were summed and divided by 3 to obtain primary irritation scores. A Primary Irritation Index (P.I.I.) which is an average of these 6 scores was also calculated.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: Primary Irritation Index (P.I.I.)
- Basis:
- other: All 6 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 5
- Reversibility:
- other: No irritation was observed; therefore reversibility is not an appropriate parameter
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- No irritation was observed at any of the time points for observation.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Not irritating when applied to the intact and abraded, shaved skin of rabbits. Primary Irritation INdex (P.I.I.) score is 0 on a scale of 0 (No irritation) to 5 (Severe irritation).
- Executive summary:
Approximately 0.5 g of the test substance, moistened with dimethyl phthalate, was applied to each site beneath a 1-inch gauze square that was held in place with non-irritating tape. The rubber sheeting was then wrapped around the animal and secured with clips to retard evaporation and to keep the test material in contact with the skin without undue pressure (OECD Guideline 404)
Approximately 24 hours after application of the test material, the rubber sheeting was loosened, and the skin at the corners of the gauze squares was marked with a waterproof pen; wrappings and gauze squares were then removed. The test sites were gently washed with paper towels and warm water to remove excess test material and gently wiped dry.
Approximately 24 hours after application of the test material, the test sites were evaluated for erythema, edema, and other evidence of dermal effects and were scored according to the Draize scale. Additional evaluations were made at 48 and 72 hours after removal of the patches. The adjacent areas of untreated skin were used for comparison.
Dermal erythema and edema are evaluated and scored at 24, 48, and 72 hours following the application of the test material at the end of the 24-hour exposure in each of 6 rabbits. The reversibility of any dermal effects is assessed for up to 14 days, if necessary. Dermal effects are quantified according to the Draize Scale.
Scores for the intact sites obtained at the 24-, 48-, and 72-hour observations are added together and a mean group score is calculated for each lesion at each of these 3 observation times. Classification of dermal irritancy potential according to the EEC is based on the mean scores for the lesions observed. An Overall Average of these 3 means is also calculated. When no dermal irritation is observed in any of the test sites, the P.I.I. is 0.
The P.I.I. score for the test substance was zero (0) and therefore the test substance is not a skin irritant when tested on the skin of rabbits.
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