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EC number: 237-580-1 | CAS number: 13846-31-6
- 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:
- 13 December 2017 to 29 December 2017 (Experimental start to experimental completion)
- 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 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 OPPTS 870.1200 (Acute Dermal Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- Diallyl hexahydrophthalate
- EC Number:
- 237-580-1
- EC Name:
- Diallyl hexahydrophthalate
- Cas Number:
- 13846-31-6
- Molecular formula:
- C14H20O4
- IUPAC Name:
- 1,2-bis(prop-2-en-1-yl) cyclohexane-1,2-dicarboxylate
- Test material form:
- liquid
- Remarks:
- Colourless
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source of test material: Osaka Soda Co Ltd., Japan
- Lot/batch No.of test material: 40201
- Expiration date of the lot/batch: 26 January 2019
- Purity test date: 26 September 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, protected from light
- Stability under test conditions: Assmued stable for the duration of the test
- Solubility and stability of the test substance in the solvent/vehicle: Not applicable, test item administered as supplied.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Not applicable, no vehicle used. Test item was administered as supplied.
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None, test item used as supplied.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI Wistar rats
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sandhofer Weg 7, D-97633 Sulzfeld, Germany
- Males: yes
- Females (if applicable): yes, nulliparous and non-pregnant
- Age at study initiation: Young adult rats
- Weight at study initiation: 241g - 270g
- Fasting period before study: Not specified
- Housing: Individual caging (Type II. polypropylene/polycarbonate)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 or 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.1 - 25.0°C
- Humidity (%): 30-48%
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
IN-LIFE DATES: From: To: 13 December 2017 to 29 December 2017 (Experimental start to experimental completion)
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: Back of each animal
- % coverage: Approximately 10% area of the total body surface
- Type of wrap if used: semi-occlusive plastic wrap
REMOVAL OF TEST SUBSTANCE
- Washing (if done): At the end of 24 hour treatment, washed with water at body temperature
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): Test item administered as a single (limit) dose at 2000 mg/kg bw (without vehicle) as supplied. - Duration of exposure:
- 24-hour
- Doses:
- Single (limit) dose of 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 animals / sex
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on day of treatment at 1 and 5 hours after application of test item and once each day for 14 days thereafter. Body weights were recorded on Day 0 prior to test item administration and on days 7 and 14 (prior to necropsy)
- Necropsy of survivors performed: yes, macroscopic examination was performed on all animals. All animals were anaesthetised with pentobarbital sodium and exsanguinated. Following confirmation of death, after examination of the external appearance, the cranial, thoracic and abdominal cavities were opened and the appearance of the tissues and organs was observed. All macroscopic changes were recorded.
- Other examinations performed: Observations included skin and fur, eyes and mucous membranes, the respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was given to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Gross macroscopic examination was performed on all animals at necropsy at the end of the 2-week observation period.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- no indication of skin irritation up to the relevant limit dose level
- Mortality:
- The test item did not cause mortality at the dose level of 2000 mg/kg bw
- Clinical signs:
- Systemic Clinical Signs: No systemic clinical signs were noted in any animal throughout the study
Local Dermal Signs: No adverse local dermal signs were observed after treatment with the test item or during the 14 days observation period. - Body weight:
- One out of 10 animals had body weight loss (-3g) between Day 0-7. This bodyweight loss was temporary and returned to normal range later in the study. There were no treatment related effects on body weight or body weight gain during the observation period.
- Gross pathology:
- There was no evidence of any gross macroscopic changes at a dose level of 2000 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal median lethal dose (LD50) of the test item MDAC was found to be greater than 2000 mg/kg body weight in male and female Crl:WI rats.
According to the GHS criteria. MDAC can be ranked as "Unclassified" for acute dermal exposure. - Executive summary:
An acute dermal toxicity study was performed with the test item MDAC in male and female Crl:WI Wistar rats, in compliance with OECD Guideline No. 402, Commission Regulation (EC) No 440/2008, B.3 and OPPTS 870.1200 [1 -3].
A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as a single dermal 24 -hour exposure followed by a 14 -day observation period.
Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured on Day 0 (prior to dosing) and on Days 7 and 14 (before necropsy). Gross macroscopic examination was performed on all animals at necropsy at the end of the 2 -week observation period (Day 14).
Application of MDAC at 2000 mg/kg bw had no effect of mortality, no observable systemic clinical signs, no adverse local dermal signs, and no treatment related effects on body weight and body weight gain. No gross macroscopic changes were observed at necropsy.
The study concluded that the acute dermal median lethal dose of MDAC was >2000 mg/kg bw in male and female Crl:WI rats. According to GHS criteria, MDAC can be ranked as "Unclassified" for acute dermal exposure.
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