Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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: 205-524-5 | CAS number: 142-16-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07.03.1994 - 24.03.1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Bis(2-ethylhexyl) maleate
- EC Number:
- 205-524-5
- EC Name:
- Bis(2-ethylhexyl) maleate
- Cas Number:
- 142-16-5
- Molecular formula:
- C20H36O4
- IUPAC Name:
- bis(2-ethylhexyl) but-2-enedioate
- Reference substance name:
- Dioctyl maleate
- EC Number:
- 220-835-6
- EC Name:
- Dioctyl maleate
- Cas Number:
- 2915-53-9
- Molecular formula:
- C20H36O4
- IUPAC Name:
- dioctyl but-2-enedioate
- Details on test material:
- - Name of test material (as cited in study report): Dioctylmaleinat (DOM)
- Chemical name (as cited in study report): (Z)-2-Butendisäure-bis-(2ethylhexyl)ester
- Substance type: active substance
- Physical state: colorless-yellowish liquid
- Analytical purity: 96.1%
- Lot/batch No.: Ch 35559, Beh. 828
- Expiration date of the lot/batch: August 1994 at the earliest
- Stability under test conditions: stable for at least one year
- Storage condition of test material: in a tightly closed vessel in the flue to the exclusion of atmospheric oxygen
- pH: neutral
- Homogeneity: The liquid seems optically to be homogeneous
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann GmbH, Borchen, Germany
- Age at study initiation: young adults
- Weight at study initiation: mean weight male rats 158g, mean weight female rats 133.6 g
- Fasting period before study: 16 hours
- Housing: conventional housing in Makrolon cages type III
- Diet: Ssniff r 10 Alleindiät für Ratten ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3°C
- Humidity (%): 30-70%
- Air changes (per hr): 15 air changes per hour
- Photoperiod (hrs dark / hrs light): artificial light, 12 hours light/12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.13 cm³/kg bw
- Doses:
- 2000 mg/kg BW
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were conducted 30 min, 1 hour, 2, 3, 4, 5, and 6 hours post application, followed by a daily observation during the two weeks post application period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, and pathological organ changes - Statistics:
- not performed
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- none
- Clinical signs:
- other: Not observed
- Gross pathology:
- A significant dilatation of the right renal pelvis was observed in one animal, but this was considered not to be a substance-related effect as it is unlikely that this effects already occurs after two weeks. Also, this effect is often heritable.
- Other findings:
- not reported
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of dioctyl maleate to rats was > 2000 mg/kg bw
- Executive summary:
In an acute oral toxicity study (limit test) one group of fasted, adult Wistar rats (5/sex) were given a single oral dose of dioctyl maleate at a dose level of 2000 mg/kg bw and observed for 14 days. The oral LD50 males was determined to be > 2000 mg/kg bw (limit test), oral LD50 females > 2000 mg/kg bw (limit test), oral LD50 combined > 2000 mg/kg bw (limit test). No mortalities occurred and no clinical signs were observed during the observation period. Dioctyl maleate is of low toxicity. Based on the results of the present test, dioctyl maleate does not require labeling.
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.
