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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-363-4 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1992/93
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- propylidynetrimethanol, ethoxylated, esters with acrylic acid and its reactions products with dibutylamine
- EC Number:
- 701-363-4
- Molecular formula:
- Not specified UVCB - Reaction product of ethoxylated (0-7 EO) propylidenetrimethanol with acrylic acid and dibutylamine (propylidenetrimethanol with acrylic acid : dibutylamine = 5:1)
- IUPAC Name:
- propylidynetrimethanol, ethoxylated, esters with acrylic acid and its reactions products with dibutylamine
- Details on test material:
- - Name of test material (as cited in study report): Laromer LR8869
- Physical state: liquid, yellowish
- Analytical purity: 99.8%
- Lot/batch No.: 1/92
- Stability under test conditions: proven by reanalysis
- Storage condition of test material: refrigerator, exclusion of light
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach
- Age at study initiation: young adult
- Weight at study initiation: 178-190g
- Fasting period before study: 16h (water available ad lib.)
- Housing: single, in stainless steel wire mesh cages, type DK-III
- Diet (e.g. ad libitum): Kliba-lab-diet 343, ad lib.
- Water (e.g. ad libitum): tap water ad lib.
- Acclimation period: > 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12h/12h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Remarks:
- DAB 9
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 40g/100ml
- Justification for choice of vehicle: poor solubility of test substance in water
MAXIMUM DOSE VOLUME APPLIED: 5ml/kg
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: no acute toxicity expected due to chemical characteristics - Doses:
- 2000mg/kg
- No. of animals per sex per dose:
- 3 males + 3 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
observations: several times on the day of administration, thereafter: twice daily on workdays, daily on weekends
body weight: day 0, weekly thereafter and at the end of the study before the fasting period
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- no findings
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this study the median lethal dose after oral applications was found to be greater than 2000mg/kg b.w. for the male and female animals.
- Executive summary:
The study was preformed to assess the range of mortality following oral administration of the test material, applied as a solution in olive oil DAB 9, to Wistar rats.
A group of 6 fasted animals (3males and 3females) was given a single oral dose of test material preparation in olive oil DAB 9 at a dose level of 2000mg/kg body weight.
Signs of toxicity have not been noted.
The expected body weight gain has been observed in the course of the study.
No mortality occured.
No abnormalities were noted at necropsy of animals sacrificed at the end of the study.
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.
