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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: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 November 2016 (reception of animals) to 13 December 2016 (experimental completion)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- Relative humidity values (min 28-29 %) which lie outside the expected range (30-70%) where recorded twice during the study. The vehicle, PEG400, was not confirmed by the Sponsor before experimental start. These had no effect on study integrity/validity.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- yes
- Remarks:
- Relative humidity values (min 28-29 %) which lie outside the expected range (30-70%) where recorded twice during the study. The vehicle, PEG400, was not confirmed by the Sponsor before experimental start. These has no effect on study integrity/validity.
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- Relative humidity values (min 28-29 %) which lie outside the expected range (30-70%) where recorded twice during the study. The vehicle, PEG400, was not confirmed by the Sponsor before experimental start. These has no effect on study integrity/validity.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- 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
- Chemical name: 1,2-Cyclohexanedicarboxylic acid
- Test item name: MDAC
- Other name: Diallyl hexahydrophthalate
- CAS number: 13846-31-6
- Description Colourless liquid
- Source and lot No.of test material: Supplied by the Sponsor (Osaka Soda Co., Ltd.,Japan), Lot No. 40201
- Expiration date of the lot/batch: 26 January 2019
- Purity test date: 99.2%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Controlled Room Temperature (15-25 °C, below 70% Relative humidity), protected from light.
- Stability under test conditions: Assumed stable for the duration of the test
- Solubility and stability of the test substance in the solvent/vehicle: Frestly formulated at 200 mg/mL in PEG400 on the day of use, assumed stable for the duration of the test.
- Reactivity of the test substance with the solvent/vehicle: None
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final dilution of a dissolved solid, stock liquid or gel: Formulated at 200 mg/mL in PEG400 on day of administration.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- Crl:WI Wistar rats
- Sex:
- 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
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 10-11 weeks old
- Animal identification: Animals were individually identified using numbers written on the tail with an indelible marker pen. The numbers were allocated based on CiToxLAB Hungary Ltd.' s Master File, for each animal allocated to the treatment groups. Cages were identified by cards with information about study code, sex, dose group, cage number and individual animal numbers.
- Weight at study initiation: 220 - 232 g
- Fasting period before study: The night before treatment animals were fasted. The food (not water) was withheld during an overnight period. The test item
was administered by oral gavage in the morning and food returned 3 hours after treatment.
- Housing: 3 animals / cage. Cage Type II. polypropylene/polycarbonate. Lignocel 3/4-S Hygienic Animal Bedding (J. Rettenmaier & Söhne GmbH + Co.KG (D-73494 Rosenberg, Germany). For nesting, Arbocel (natural) crinklets (J. Rettenmaier & Söhne GmbH + Co.KG (D-73494 Rosenberg, Germany) were available to animals during the study. Animals were housed by group to allow social interaction and with deep wood sawdust bedding to allow digging and other normal rodent activities.
- Diet (e.g. ad libitum): ad libitum from 3 hours after treatment with test item. Animals received ssniff® SM R/M "Autoclavable complete diet for rats and mice –
breeding and maintenance" produced by ssniff Spezialdiäten GmbH, D-59494 Soest Germany (batch number: 141 8884, expiry date: 31 January 2017).
- Water (e.g. ad libitum): ad libitum. Water quality control analysis is performed every three months and microbiological assessment performed monthly. Results are retained in the archives at CiToxLAB Hungary Ltd.
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.9 - 23.7 °C
- Humidity (%): 28 - 60%
The temperature and relative humidity were recorded twice daily during the acclimatisation period and throughout the study.
- Air changes (per hr): 15-20
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light (6 a.m to 6 p.m)
IN-LIFE DATES: From: 03 November 2016 to 13 December 2016
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Details on oral exposure:
- VEHICLE
- Vehicle name: Poly(ethylene glycol) 400 (PEG 400). Manufactured by Sigma Aldrich
- Concentration in vehicle: Freshly formulated at a concentration of 200 mg/mL in the vehicle, PEG 400. Formulations were magnetically stirred continuously up to the end of dose administration procedures.
- Justification for choice of vehicle: The toxicological characteristics of PEG 400 are well known and it is routinley used as a vehicle within this test system.
- Lot no. BCBQ0052V
- Expiry date: 31 December 2016
- Storege: Room temperature
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg (200 mg/mL x 10 mL/kg)
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: The initial dose level was selected by the Study Director to be that which is most likely to produce mortality in some of the dosed animals. In the lack of any preliminary toxicological information, 2000 mg/kg bw was selected as the starting dose. - Doses:
- Two groups of three female Crl:WI rats were treated with MDAC at a dose level of 2000 mg/kg bw (Group 1 and Group 2). Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As one animal was found dead with no further mortality observed, a confirmatory group (Group 2) was treated at the same dose level. One animal was found dead in the confirmatory group; therefore no further testing was required according to OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris.
- No. of animals per sex per dose:
- 3 female rats per dose (6 animals used in total)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were performed on all animals at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was recorded day before treatment (Day -1), day of treatment (Day 0) and weekly thereafter.In the case of found dead animals, a final
body weight measurement was performed right after the recognition of death.
- Necropsy of survivors performed: yes
- Other examinations performed:
Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern. Particular attention was directed to observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
All animals were subject to necropsy and macroscopic examination. After examination of the external appearance, the cranial, thoracic and the abdominal cavities were opened and the organs and the tissues were observed.
Clinical signs, body weight, body weight gain and gross macroscopic data were all tabulated and reported.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- MDAC caused mortality in 2/6 animals (one for each treatment group) at a dose level of 2000 mg/kg bw. Animal number 3614 died on Day 1 and animal number 3615 died on Day 0.
- Clinical signs:
- Found dead animals showed decreased activity (slight to moderate), hunched back, and in one animal piloerection up to the time of death.
Surviving animals showed decreased activity in 2/4 animals up to Day 2, hunched back in 3/4 animals, up to Day 4, and piloerection in 3/4 animals up to Day 7. - Body weight:
- Minimal body weight gains and slightly reduced body weights in 2/4 animals were observed in the surviving MDAC treated animals during the study. These changes were considered possible test-item related effects.
- Gross pathology:
- In found dead animals, diffuse/focal dark/red discoloration of the non-glandular/glandular mucosa, were considered to be test item-related. Diffuse dark/red discoloration of the non-collapsed lungs found, was regarded as agonal or post mortem.
In surviving animals, there was no evidence of macroscopic changes in animals dosed at 2000 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 value of MDAC was found to be equal or above 2000 mg/kg bw in female Crl:WI Wistar rats. According the CLP criteria, MDAC is not classified for acute oral exposure.
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