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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 601-101-8 | CAS number: 111497-86-0
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 25 August 1999 - 25 February 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Laromer LR 8956X
- IUPAC Name:
- Laromer LR 8956X
- Reference substance name:
- 2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine
- EC Number:
- 601-101-8
- Cas Number:
- 111497-86-0
- Molecular formula:
- Molecular formula not available for this UVCB.
- IUPAC Name:
- 2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine
- Details on test material:
- - Name of test material (as cited in study report): Laromer LR 8956X- Physical state: Liquid / Yellowish, clear- Analytical purity: 94.9 g/100 g- Lot/batch No.: Partie 10- Storage condition of test material: Room temperature
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- Age at study initiation: Young adult animals- Weight at study initiation: animals of comparable weight (150g - 300g) (+/- 20% of the mean weight)- Housing: stainless steel wire mesh cages, type DK-III (single housing)- Diet (e.g. ad libitum): ad libitum (feed assayed for chemical and microbiological contaminants)- Water (e.g. ad libitum): Tap water ad libitum per day- Acclimation period: acclimatization for at least 1 weekENVIRONMENTAL CONDITIONS- Temperature (°C): The animals were housed in fully air-contitioned rooms. Central air-conditioning guaranteed a range of 20 - 24 degrees centigrade for temperature and of 30 - 70 % for relative humidity. There were no deviations from these ranges, which influenced the results of the study.- Photoperiod (hrs dark / hrs light): 12 h/12 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE- Concentration in vehicle: 40.00 g/100mL- Amount of vehicle (if gavage): 5.00 ml/kg- Justification for choice of vehicle: The test substance could not be homogeneously distributed in aqua bidest.
- Doses:
- 2,000 mg/kg bw
- No. of animals per sex per dose:
- 3 males / 3 females
- Control animals:
- not specified
- Details on study design:
- - Duration of observation period following administration: 14 days - Examinations performed: clinical signs and symptoms, body weight,mortality, pathology: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality.
- Clinical signs:
- other: Signs of toxicity noted in female animals comprised impaired general state, dyspnoea and staggering. These syptoms were considered to be unspecific toxicity symptoms. The animals appeared normal 2 days after application.The male rats did not show any sym
- Gross pathology:
- No abnormalities were noted at necropsy of animals sacrificed at the end of the study.
Applicant's summary and conclusion
- Conclusions:
- Under the test conditions, the LD50 value of the test substance was > 2,000 mg/kg bw.
- Executive summary:
A study was conducted to determine the acute oral LD50 of the test substance according to EPA OPPTS 870.1100, OECD Guideline 423 and EU Method B.1.
No mortality was observed at the dose level of 2,000 mg/kg bw .
Under the conditions of the study, the LD50 of the test substance was therefore >2,000 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.
