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Diss Factsheets
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EC number: - | CAS number: -
- 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
- Remarks:
- Read-across from a structural analogue
- Adequacy of study:
- key study
- Study period:
- 27 September 2006 to 11 October 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Test material form:
- solid: particulate/powder
- Specific details on test material used for the study:
- Sample ID: AD-1500
Physicalstate:white powder
-Expiration date of the lot/batch: 01 August 2008
-Stability under storage conditions: stable
- Storage condition of test material: At room temperature in the dark
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
-Source: Charles River Deutschland, Sulzfeld, Germany
-Age at study initiation: approx. 9 weeks old
-Weight at study in iation: Variation in body weight did not exceed=/- 20% of the sex mean.
- Fasting period before study: not applicable
-Housing: Individually housed in labeled Macrolon cages (Mill type, height 18 em.) containing sterilized sawdust as bedding material and
paper as cage-enrichment.
-Diet (e.g. ad lib um): Free access to standard pelleted rodent diet
-Water (e.g. ad libitum): Free access to tap water.
-Acclimation period: Acclimatization period was at least 5 days before start of treatment under laboratory conditions.
ENVIRONMENTAL CONDITIONS
-Temperature ("C): 21.0 +/- 3.0
-Humidity(%): 30- 70
-Air changes (per hr): 15
-Photoperiod (hrs dark I hrs light): 12/12
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- propylene glycol
- Details on dermal exposure:
- TEST SITE
-Area of exposure: approx. 25 cm2 for males and 18 cm2 for females (10% of total body surface)
- % coverage: all
-Type of wrap if used: The formulation was held in contact with the skin with a dressing, consisting of a surgical gauze patch, successively
covered with aluminum foil and Caban elastic bandage. A piece of Micropore tape was additionally used for fccation of the bandages in females only.
REMOVAL OF TEST SUBSTANCE
-Washing (if done): skin cleaned of residual test substance using tap water
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with un ): 2000 mglkg (10 mUkg) body weight
-Constant volume or concentration used: yes
VEHICLE: Propylene glycol (specific gravity 1.036).
Rationale: The vehicle was selected based on trial formulations performed at NOTOX and on test substance data supplied by the sponsor. Preparation: The formulation (wlw) was prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level. Adjustment was made for specific gravity of the vehicle. - Duration of exposure:
- 24h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Details on study design:
- -Duration of observation period following administration: 14 days
MortalityNiability: Twice daily.
Body weights: Days 1 (pre-administration), 8 and 15.
Clinical signs: At periodic intervals on the day of dosing (day 1) and once daily thereafter, until day 15. The time of onset, degree and duration were recorded and the symptoms graded according to fixed scales:
Necropsy: At the end of the observation period, all animals were sacrificed by oxygen/carbon dioxide procedure and subjected to necropsy.
Descriptions of all internal macroscopic abnormalities were recorded.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortalities
- Clinical signs:
- Signs of toxicity: Flat posture, ptosis and/or chromodacryorrhoea were noted among the animals on day 1
- Body weight:
- The changes noted in body weight gain in males and females were within the range expected for rats used in this type of study and were therefore considered not indicative of toxicity.
- Gross pathology:
- Effects on organs:
No abnormalities were found at macroscopic post mortem examination of the animals - Other findings:
- Signs of toxicity (local}:
Scales, scabs and/or erythema were seen in the treated skin- area of the animals during the observation period.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Dermal LD50 for the test substance for rats was established at >2000 mg/kg bw.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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