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Diss Factsheets
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EC number: 482-670-8 | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 28 May 2007 to 13 December 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: the study was performed according to internationally recognised guidelines and GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- slight high body weight of one animal on day 1 (this minor deviation was not considered to have compromised the validity or integrity of the study).
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- yes
- Remarks:
- see higher
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- see higher
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: on the day of treatment, the animals were approximately 8 weeks old
- Weight at study initiation: on the day of treatment, the animals had a mean body weight of 314 ± 5 g for the males and 217 ± 9 g for the females
- Fasting period before study: no
- Housing: during the treatment period, the animals were housed individually in polycarbonate cages with stainless steel lid (35.5 cm x 23.5 cm x 19.3 cm)
- Diet: free access to SsniffR/M-H pelleted diet (SSNIFF Spezialdiäten GmbH, Soest, Germany)
- Water: drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2°C
- Humidity: 30 to 70%
- Air changes: approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod: 12hrs dark / 12hrs light
IN-LIFE DATES: from 12 June 2007 (treatment) to 26 June 2007 (necropsy of the last animal)
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: dorsal area
- % coverage: approximately 10% of the total body surface of the animals
- Type of wrap if used: gauze pad held in contact with the skin by means of an adhesive hypoallergenic aerated semi-occlusive dressing and a restraining bandage
REMOVAL OF TEST SUBSTANCE
- Washing: yes (using a dry cotton pad)
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount applied: 2000 mg/kg bw
- For solids, paste formed: yes (the hydrophilic gauze pad was pre-moistened with 2 mL of purified water) - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- five males and five females
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
> Clinical signs and mortality: frequently during the hours following administration of the test item, at least once a day thereafter. From day 2, any local cutaneous reaction was recorded.
> Body weight: the animals were weighed individually just before administration of the test item on day 1 and then on days 8 and 15.
- Necropsy of survivors performed: yes
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 mortality observed
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- other: No systemic clinical signs were observed during the study. Crusts were noted in one female from day 11 until day 15 (end of the observation period).
- Gross pathology:
- Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Dermal LD50 of neodymium tris(di-2-ethylhexylphosphate) is higher than 2000 mg/kg bw for male and female rats.
- Executive summary:
In an acute dermal toxicity study according to OECD TG 402, EC B.3, OPPTS 870.1200 and GLP (CIT report No.33192 TAR, 2007), scored as validity 1 according to Klimisch criteria, a group of 8-week old Sprague-Dawley rats (5/sex) were applied a single dermal dose of undiluted neodymium tris(di-2-ethylhexylphosphate) at the dose of 2000 mg/kg bw (limit test) under a semi-occlusive dressing applied for 24 hours. The animals were observed for 14 days. Clinical signs and mortality were checked frequently during the hours following administration of the test substance, and at least once a day thereafter. Body weight was measured just before administration of the test substance on day 1 and then on days 8 and 15. Local tolerance was also observed from Day 2.
No deaths and no systemic clinical signs were observed during the study.
Crusts were noted in one female from day 11 until day 15 (end of the observation period).
When compared to historical control animals, a slightly lower body weight gain was noted in 1/5 females between day 8 and day 15. The overall body weight gain of the other animals was not affected by treatment with the test item.
No apparent abnormalities were observed at necropsy in any animal.
Under the experimental conditions of this study, the dermal LD50 of the test item neodymium tris(di-2-ethylhexylphosphate) was higher than 2000 mg/kg in rats.
No classification for acute dermal toxicity is warranted based on the absence of mortality up to a limit dose level, according to the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS.
This study is classified as acceptable, as it is performed according to OECD guideline and GLP.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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