Registration Dossier
Registration Dossier
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: 826-122-1 | CAS number: 13431-57-7
- 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
- Adequacy of study:
- key study
- Study period:
- 12 - 28.03.2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- February 24, 1987
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 3-(acetyloxy)-2,2-dimethylpropyl acetate
- EC Number:
- 826-122-1
- Cas Number:
- 13431-57-7
- Molecular formula:
- C9 H16 O4
- IUPAC Name:
- 3-(acetyloxy)-2,2-dimethylpropyl acetate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: ZH 472 redestilliert.
- Expiration date of the lot/batch: January 2020.
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature. The stability of the test item under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Homogeneity: The test item was homogeneous by visual inspection.
- Analysis of the test item preparation: Because the test item was used undiluted, no samples were taken.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: none. The test item was applied undiluted.
FORM AS APPLIED IN THE TEST (if different from that of starting material) : undiluted.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Rat / Wistar / Crl:WI (Han) SPF
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Germany.
- Females (if applicable) nulliparous and non-pregnant: yes.
- Age at study initiation: Young adult animals (male animals approx. 8 weeks, female animals approx. 12 weeks).
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight).
- Housing: Single housing in Makrolon cage, type III. Bedding: H 15005-29; Ssniff, Spezialdiäten GmbH (Experimental Animal Diets Inc., 59494 Soest, Germany). Cage enrichment. The animals were housed in fully air-conditioned rooms.
- Diet: VRF1(P); SDS Special Diets Services, 67122 Altrip, Germany, ad libitum.
- Water: Tap water ad libitum.
- Acclimation period: Acclimatization period of at least 5 days before the beginning of the experimental phase; during the acclimatization period, the animals were accustomed to the environmental conditions of the study and to the diet.
- Identification: Individual identification by cage cards and tail marking.
- Reasons for selection of the test species: Rats were selected since this rodent species is recommended in the respective test guidelines. Wistar rats were selected since there is extensive experience available in the laboratory with this strain of rats.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C.
- Humidity (%): 30 – 70% relative humidity.
- Air changes (per hr): Approx. 10.
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.).
IN-LIFE DATES: From: 13.03.2018 To: 27.03.2018.
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: About 40 cm² covering dorsal and dorsolateral parts of the trunk.
- % coverage: 10% of the body surface.
- Type of wrap if used: semi-occlusive dressing.The test item was covered with an air-permeable dressing (4 layers of absorbent gauze (Ph. Eur. supplied by Lohmann GmbH & Co., KG) and stretch bandage (Fixomull® Stretch (adhesive fleece) supplied by Beiersdorf AG).
- Clipping of the fur: About 24 hours before application.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, rinsing of the application site with warm water.
- Time after start of exposure: 24 hours.
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1.97 mL/kg bw.
- Concentration (if solution): undiluted. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw / undiluted.
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days.
- Body weight determination: Individual body weights shortly before application (day 0), weekly thereafter and on the last day of observation.
- Clinical observations: Clinical signs for each animal were recorded several times on the day of application and at least once during each workday thereafter.
- Scoring of skin findings: Individual readings 30 – 60 minutes after removal of the semi-occlusive dressing (day 1), weekly thereafter and on the last day of observation.
- Mortality: A check for any dead or moribund animals was made at least once each workday, these records are archived by Bioassay.
- Pathology: Necropsy with gross-pathology examination was performed on the last day of the observation period after sacrifice by CO2-inhalation in a chamber with gradually increasing concentrations.
Assessment of skin reactions:
- The evaluation of skin reactions was performed according to Draize, J. H. "Dermal toxicity." Appraisal of the safety of chemicals in foods, drugs and cosmetics (1959): 46-59. Appraisal of the safety of chemicals in foods, drugs and cosmetics. The association of food and drug officials of the United States Austin, Texas:
- Erythema and eschar formation Grading: 0 - No erythema, 1 - Very slight erythema (barely perceptible), 2 - Well- defined erythema, 3 - Moderate to severe erythema, 4 - Severe erythema (beet redness) to eschar formation preventing grading of erythema.
- Edema formation Grading: 0 - No edema, 1 - Very slight edema (barely perceptible), 2 -Slight edema (edges of area well- defined by definite raising), 3 - Moderate edema (raised approx. 1 mm), 4- Severe edema (raised more than 1 mm and extending beyond area of exposure).
- Descriptions of any dermal findings not covered by this scale were recorded.
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 occured
- Mortality:
- No mortality occurred.
- Clinical signs:
- other: No systemic clinical signs were observed during clinical examination.
- Gross pathology:
- No macroscopic pathologic abnormalities were noted in any animal examined at the end of the study (5 males and 5 females).
- Other findings:
- No local effects were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of this study the median lethal dose (LD50) of the test item after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.
- Executive summary:
In an acute dermal toxicity study (Limit Test), young adult Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 2000 mg/kg bw of the undiluted test item to the clipped application site (dorsal and dorso-lateral parts of the trunk and covered by semi-occlusive dressing during the 24-hour exposure period. The application area comprised at least 10% of the total body surface). The animals were observed for 14 days.
- No mortality occurred.
- Neither signs of systemic toxicity nor local skin effects were observed in the animals.
- All animals gained weight in a normal range throughout the study period.
- No macroscopic pathologic abnormalities were noted in any animal examined at the end of the study (5 males and 5 females).
Accordingly, the acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 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.
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.
