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Diss Factsheets
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EC number: 413-110-2 | CAS number: 135861-56-2
- 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:
- 5th March 1993 to 16th June 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline studies with restrictions. Information relating to the test animals, exposure and test system were not described in the main body of the report but were given in the protocol only.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
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 OTS 798.1100 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- Purity: 97.3%
Batch No.: 9236-23
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS (information given in the study protocol)
- Source: Iffa-Credo BP 0109 (69592 L'Arbresle Cedex - France)
- Age at study initiation: adult 5 to 7 weeks old
- Weight at study initiation: Males: 252-278 g; Females: 226-244 g
- Fasting period before study: Not specified
- Housing: Animals housed individually in polycarbonate cages type Fl (305 x 180 x 184 mm). Bedding was dust-tree sawdust made from spruce tree wood, analysed twice a year for chemical and bacterial contaminants.
- Diet (e.g. ad libitum): Pelleted complete diet available ad libitum (rat-mouse Diet reference AO4 C10, Usine d'Alimentation Rationnelle, Villemoisson s/Orge, France)
- Water (e.g. ad libitum): Filtered (0.2 µm) mains drinking water available ad libitum.
- Acclimation period: Minimum of 5 days
ENVIRONMENTAL CONDITIONS (information given in the study protocol)
- Temperature (°C): 19 to 25 °C
- Humidity (%): 30-70%
- Air changes (per hr): Minimum 8 air changes per hour
- Photoperiod: 12 hours light (artificial)/12 hours dark
IN-LIFE DATES: Not specified
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: Sterile Codex liquid paraffin
- Details on dermal exposure:
- TEST SITE (information given in the study protocol)
- Area of exposure: The day before the application of the test article, the back and the flanks of each animal were carefully clipped, to expose an area of skin which should not be less than 10 % of the total body surface area.
- % coverage: The test article was applied so that it formed a film as thin and as uniform as possible (% coverage not specified).
- Type of wrap if used: The semi-occlusive bandage covered fully the treated area, in order to prevent ingestion of the test article.
REMOVAL OF TEST SUBSTANCE (information given in the study protocol)
- Washing (if done): At the end of the 24 hour period, the binders were removed and the skin wiped clean of residual test article using water or other convenient means.
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): See below
- Concentration (if solution): Not applicable
- Constant volume or concentration used: Not specified
- For solids, paste formed: Yes (pH = 5.7)
VEHICLE
- Amount(s) applied: 4.199 mL/kg bw of test material in the vehicle
- Concentration: 47% test article in the vehicle
- Batch no.: T8810B
- Purity: Not specified - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males and 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Examinations for mortality and abnormal clinical signs were performed 15 minutes after application, then at 1, 2 and 4 hours, and then daily for the 14 day study period. Cutaneous examinations were performed from day 2 to 15.
- Necropsy of survivors performed: Yes
- Other examinations performed: All the animals were weighed, immediately before application of the test article (Day 1), on Days 8 and 15. - Statistics:
- No data available
Results and discussion
- Preliminary study:
- Not performed
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0 - Clinical signs:
- other: There were no changes in behaviour or clinical signs in any of the treated animals during the observation period. The local tolerance of the test article was good; no cutaneous lesion (erythema or oedema) was noted to the application site of the test arti
- Gross pathology:
- There were no macroscopic findings that could be associated with treatment.
- Other findings:
- None reported
Applicant's summary and conclusion
- Interpretation of results:
- other: EU-GHS criteria not met
- Conclusions:
- From the results obtained under the experimental conditions employed, the LD 50 by the cutaneous route in the rat (male + female) is >2000 mg/kg.
- Executive summary:
The test material, Millad®3988, was evaluated for its acute dermal toxicity potential in male and female rats following a single cutaneous application at a dose level of 2000 mg/kg bw. The estimated dermal LD50 values for male and female rats were determined to be greater than 2000 mg/kg bw. All animals appeared normal and exhibited body weight gain throughout the study. The gross necropsy examinations at termination revealed no macroscopic findings that could be associated with treatment.
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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