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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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with national standard methods
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A single dose of the test substance was applied to the shaved, abraded skin of 5 male and 5 female New Zealand White rabbits at a dosage of 2000 mg/kg of body weight. The application site was occluded for 24 hours. The rabbits were weighed and observed for 14 days (weekends excluded) following removal of the test material. At the end of the observation period, 2 male and 2 female rabbits were killed and examined for gross and histomorphologic changes.
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- no
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
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Buckshire Corporation, Perkasie, Pennsylvania
- Females (if applicable) nulliparous and non-pregnant: No data are provided in the report
- Age at study initiation: Young adult
- Weight at study initiation: The rabbits weighed between 2366 and 2927 grams on the day of dosing
- Fasting period before study: No data are provided in the report
- 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): Source of water was not provided in the report
- Acclimation period: Two weeks
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 2°C
- Humidity (%): 50% ± 10%.
- Air changes (per hr): No data are provided in the report
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark cycle
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: The aliquot of test material designated for an animal was moistened with dimethyl phthalate to form a paste
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Approximately 190 square centimeters
- % coverage: 190 square centimeters is approximately equal to 10 percent of
the total body surface area of rabbits in the 2 - 3 kg body weight range
- Type of wrap if used: The rabbits were then wrapped with successive layers of plastic film, stretch gauze bandage and elastic adhesive bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Excess test material was wiped from the animals' backs with dry paper towels
- Time after start of exposure: Approximately 24 hours after application
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg of body weight
- Concentration (if solution): Paste
- Constant volume or concentration used: yes
- For solids, paste formed: yes - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5 male and 5 female rabbits per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed approximately every other day (weekends excluded) until the 14th day post application
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross and histopathology - Statistics:
- No
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no deaths at highest dose tested
- Mortality:
- No rabbits died within 14 days after application of 2000 mg/kg of test substance
- Clinical signs:
- other: Clinical observations during the study were limited to body weight effects; no other clinical signs of toxicity were observed in any rabbit throughout the study
- Gross pathology:
- No gross or microscopic compound-related effects' were observed in rabbits killed 14 days after treatment
- Other findings:
- One rabbit exhibited severe erythema 1 day after application; the skin appeared normal at 3 days. No other dermal irritation was present throughout the remainder of the test
Any other information on results incl. tables
Individual body weights (g) of male rabbits after dermal exposure to the test substance
Animal # |
Initial body weight |
Body weight on day 1 |
Body weight on day 3 |
Body weight on day 6 |
Body weight on day 8 |
Body weight on day 10 |
Body weight on day 13 |
Body weight on day 14 |
19881 |
2524 |
2415 |
2569 |
2711 |
2766 |
2808 |
2961 |
3035 |
19882 |
2460 |
2427 |
2475 |
2634 |
2687 |
2724 |
2723 |
2769 |
19883 |
2366 |
2273 |
2379 |
2409 |
2537 |
2611 |
2694 |
2734 |
19884 |
2563 |
2514 |
2634 |
2643 |
2745 |
2852 |
2939 |
2950 |
19885 |
2927 |
2904 |
2975 |
2959 |
3023 |
3050 |
3074 |
3071 |
Individual body weights (g) of female rabbits after dermal exposure to the test substance
Animal # |
Initial body weight |
Body weight on day 1 |
Body weight on day 3 |
Body weight on day 6 |
Body weight on day 8 |
Body weight on day 10 |
Body weight on day 13 |
Body weight on day 14 |
19840 |
2746 |
2714 |
2888 |
2818 |
2920 |
2978 |
2973 |
3059 |
19841 |
2927 |
2900 |
3048 |
3096 |
3132 |
3190 |
3198 |
3102 |
19842 |
2862 |
2602 |
2861 |
2934 |
2972 |
3058 |
3123 |
3115 |
19843 |
2508 |
2508 |
2652 |
2611 |
2731 |
2756 |
2771 |
2825 |
19844 |
2609 |
2557 |
2696 |
2704 |
2856 |
2991 |
2986 |
2992 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 for male and female New Zealand White rabbits was greater than 2000 mg/kg of body weight.
- Executive summary:
A single dose of the test substance was applied to the shaved, abraded skin of 5 male and 5 female New Zealand White rabbits at a dosage of 2000 mg/kg of body weight. The application site was occluded for 24 hours. The rabbits were weighed and observed for 14 days (weekends excluded) following removal of the test material. At the end of the observation period, 2 male and 2 female rabbits were killed and examined for gross and histomorphologic changes.
No rabbits died within 14 days after dosing. Slight or moderate weight losses (up to 9% of initial body weight) occurred in the rabbits the day after application of the test material. One rabbit exhibited severe erythema 1 day after application; the skin appeared normal at 3 days. No other dermal irritation was present throughout the remainder of the test. No gross or microscopic compound-related effects' were observed in rabbits killed 14 days after treatment.
Under the conditions of this test, the skin absorption LD50 was greater than 2000 mg/kg of body weight, the highest dose tested.
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