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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
![](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:
- April - May 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study according to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- Batch no. 1400-005
Storage at ca. 4 degr C
42% peroxide in aliphatic hydrocarbons
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Animals and Animal Husbandry
Five male and five female Sprague-Dawley CD (Crl : CD ® BR) strain rats
supplied by Charles River (UK) Ltd, Margate, Kent were used. At the start of
the study the males weighed 206 to 228g, and the females 209 to 233g, and
were approximately eight to twelve weeks old. After a minimum
acclimatisation period of five days the animals were selected at random and
given a number unique within the study by indelible ink-marking on the tail
and a number written on a cage card.
The animals were housed in suspended polypropylene cages furnished with
woodflakes. The animals were housed individually during the 24-hour
exposure period and in groups of five, by sex, for the remainder of the study.
Free access to mains drinking water and food (Rat and Mouse Expanded Diet
No.1, Special Diets Services Limited, Witham, Essex, UK) was allowed
throughout the study.
The animal room was maintained at a temperature of 19 to 24 degrees C and relative
humidity of 47 to 54%. The rate of air exchange was approximately fifteen
changes per hour and the lighting was controlled by a time switch to give
twelve hours continuous light and twelve hours darkness.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- other: None, test material was administered as supplied
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- For the purpose of the study the test material was used as supplied. The
specific gravity was determined and used to calculate the appropriate dose
volume for the required dose level.
On the day before treatment the back and flanks of each animal were clipped
free of hair using veterinary clippers.
DOSE LEVEL(mg/kg): 2000
SPECIFIC GRAVITY: 0.882
DOSE VOLUME (ml/kg): 2.27
The calculated volume of the test material, as received, was applied uniformly
to an area of shom skin (approximating to 10% of the total body surface area)
using a graduated syringe. A piece of surgical gauze was placed over the
treatment area and semi-occluded with a piece of self-adhesive bandage. The
bandage was further secured with a piece of BlENDERM wrapped around each
end. The animals were caged individually for the 24-hour exposure period.
Shortly after dosing the dressings were examined to ensure that they were
securely in place.
The animals were observed for deaths or overt signs of toxicity l/2, 1,2 and
4 hours after dosing and subsequently once daily for fourteen days.
After the 24-hour contact period the bandage was carefully removed and the
treated skin and surrounding hair wiped with cotton wool moistened with
distilled water to remove any residual test material. The animals were returned
to group housing for the remainder of the study period.
After removal of the dressings and subsequently once daily for fourteen days,
the test sites were examined for evidence of primary irritation and scored
according to the following scale from Draize J H (1977) "Dermal and Eye
Toxicity Tests" In: Principles and Procedures for Evaluating the Toxicity of
Household Substances, National Academy of Sciences, Washington DC p.31:
Results and discussion
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:
- Signs of toxicity related to dose levels: no signs of systemic toxicity were noted during the study.
- Gross pathology:
- Effects on organs: no abnormalities noted at necropsy.
- Other findings:
- Signs of toxicity (local): no effects of skin irritation or any other local effects were noted during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The acute dermal median lethal dose (LD50 of the test material, in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg
bodyweight. - Executive summary:
A study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley CD strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals No. 402 "Acute Dermal Toxicity" (adopted 24 February 1987) and Method B3 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC).
A group of ten animals (five males and five females) was given a single 24-hour, semioccluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of treatment and were then killed for gross pathological examination. There were no deaths. No signs of systemic toxicity or skin irritation were noted during the study. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy.
The acute dermal median lethal dose (LDso) of the test material (which is one of the major component of CAS 1613243 -54 -1) in the SpragueDawley CD strain rat was found to be greater than 2000 mg/kg bodyweight.
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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