Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 614-455-3 | CAS number: 68411-07-4
- 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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28 May 2010 - 30 June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Compliant to GLP and testing guideline; adequate coherence between data, comments and conclusions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- Copper Lead Resorcylate Salicylate Complex
- EC Number:
- 614-455-3
- Cas Number:
- 68411-07-4
- Molecular formula:
- C7H5O4-, C7H5O3- Cu , Pb
- IUPAC Name:
- Copper Lead Resorcylate Salicylate Complex
- Details on test material:
- - Name of test material (as cited in study report): Lead-Cooper-Resorcylate-Salicylate (LC 12-15)
- Substance type: multicontituent
- Physical state: slightly pale green powder
- Composition of test material, percentage of components: copper: 11.9%, lead: 35.7%, resorcylate: 14.1%, salicylate: 35.7%
- Lot/batch No.: 09/201
- Expiration date of the lot/batch: 04 November 2011
- Storage conditions of test material: at room temperature.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Breeder: Janvier, Saint-Genest-Saint-Isle, France
- Age at study initiation: on the day of treatment, the animals were approximately 8 weeks old
- Weight at study initiation: mean body weight ± standard deviation of 207 ± 12 g
- Fasting period before study: approximately 18 hours
- Housing: cages with stainless steel lid (43 cm x 22 cm x 20 cm)
- Diet (e.g. ad libitum): free access to SSNIFF R/M-H pelleted diet
- Water (e.g. ad libitum): free access to bottles containing tap water (filtered with a 0.22 µm filter)
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 50 +/- 20%
- Air changes (per hr): 12 cycles/hour
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
IN-LIFE DATES: From: 02 June 2010 To: 30 June 2010.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5% methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 30 and 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg
- Justification for choice of vehicle: standard vehicle used for specific routes of administration
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Taking into account information on the test item, the starting dose-level of 300 mg/kg was chosen. - Doses:
- 300 and 2000 mg/kg.
- No. of animals per sex per dose:
- 3 females per group and per dose.
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: a period of up to 14 days
- Frequency of observations and weighing: Each animal was observed after dosing at least once during the first 30 minutes, periodically during
the first 24 hours for detection of possible treatment-related clinical signs and then at least once a day for 14 day.
The body weight of each animal was recorded just before administration of the test item on day 1 and then on days 8 and 15.
- Necropsy of all animals performed: yes.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No unscheduled mortality were observed during the study.
- Clinical signs:
- other: No clinical signs were observed during the study.
- Gross pathology:
- Macroscopic post-mortem examination of the main organs of the animals revealed no apparent abnormalities.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The oral LD50 of the test item, Lead Copper Resorcylate-Salicylate (LC 12-15), was higher than 2000 mg/kg in rats.
According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations) on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labeling of dangerous substances, concerning the potential toxicity by oral route, the test item, Lead-Copper-Resorcylate-Salicylate (LC 12-15), should not be classified. - Executive summary:
The objective of this study was to evaluate the toxicity of the test item, Lead‑Copper‑Resorcylate‑Salicylate (LC 12-15), following a single oral administration in rats according to OECD (No. 423, 17th December 2001) and Commission Regulation (EC) (No. 440/2008, B.1tris, 30 May 2008)guidelines.
The study was conducted in compliance with the principles of Good Laboratory Practice Regulations.
Methods
The test item, Lead-Copper-Resorcylate-Salicylate (LC 12-15), was administered by oral route (gavage) to groups of three fasted female Sprague-Dawley rats at dose-levels of 300 and 2000 mg/kg under a dosage-volume of 10 mL/kg. The test item was prepared in 0.5% methylcellulose.
The study design was as follows:
Dose-level
(mg/kg)
Volume
(mL/kg)
Female
300
10
3
2000
10
3
2000
10
3
Each animal was observed at least once a day for mortality and clinical signs for a period of up to 14 days following the single administration. Body weight was recorded on day 1 and then on days 8 and 15.
On completion of the observation period, the animals were sacrificed then subjected to a macroscopic post-mortem examination.
The interpretation of results was based on the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations).
Results
No unscheduled mortality and noclinical signs were observed during the study.
When compared to CIT historical control data, a lower body weight gain was noted between day 8 and day 15 in 1/3 females treated at the dose-level of 300 mg/kg (vs.15 ± in control data base) and between day 1 and day 8 in 4/6 females treated at the dose-level of 2000 mg/kg (24 to 31 g vs.41 ± 9 g in control data base). The body weight gain returned to normal thereafter.
At necropsy, no apparent abnormalities were observed in any animal.
Conclusion
Under the experimental conditions of this study, the oral LD50 of the test item, Lead‑Copper‑Resorcylate-Salicylate (LC 12-15), was higher than 2000 mg/kg in rats.
According to the classification criteria laid down in Council Directive 67/548/EEC (and subsequent adaptations), concerning the potential toxicity by oral route, the test item should not be classified.
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.