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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 306-246-8 | CAS number: 96690-51-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- Jan 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Performed pre-GLP, method is described briefly (refer to the "principles of method" field)
- Principles of method if other than guideline:
- - Short description of test conditions: Dermal application of Nourypol 200 at dose levels of 0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight
- Parameters analysed / observed: growth, food and water intake and haematology, as well ass Gross examination at autopsy - GLP compliance:
- no
- Remarks:
- Prior to GLP adoption
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Soybean oil, epoxidized, Me ester, reaction products with propylene glycol
- EC Number:
- 306-246-8
- EC Name:
- Soybean oil, epoxidized, Me ester, reaction products with propylene glycol
- Cas Number:
- 96690-51-6
- IUPAC Name:
- Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Not Specified
Test animals
- Species:
- rabbit
- Strain:
- other: Albino
- Remarks:
- No further specification regarding the strain
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not specfied
Administration / exposure
- Type of coverage:
- not specified
- Vehicle:
- not specified
- Details on dermal exposure:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight
- Duration of exposure:
- Not specified
- Doses:
- 0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight
- No. of animals per sex per dose:
- Not specified
- Control animals:
- yes
- Remarks:
- The 0.0 ml/kg body weight (control) dosed group was used as control
- Details on study design:
- - Frequency of observations and weighing: Haeatological data was obtained 2 weeks after a single dermal appliaction. other observation frequencies are not specified.
- Necropsy of survivors performed: yes
- Other examinations performed: growth, food and water intake, haematology, gross examination - Statistics:
- not specified
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 9 mL/kg bw
- Based on:
- test mat.
- Mortality:
- No
- Clinical signs:
- other: slight skin effects at 3.0 and 6.0 ml/kg and slight to moderate skin effects at 9.0 ml/kg.
- Gross pathology:
- Gross examination at autopsy did not reveal any clearly treatment-related changes
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- Based on CLP criteria
- Conclusions:
- Under the conditions of the test, the dermal LD50 was > 9 mL/kg bw (which corresponds to > 8.856 g/kg bw). Therefore, the substance does not need to be classified for acute toxicity in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).
- Executive summary:
An acute dermal toxicity study with "Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was performed in a study similar to OECD TG 402, pre-GLP, scored Klimisch 2.
"Soybean oil, epoxidized, methyl ester, reaction products with propylene glycol" was tested at 0.0 (control), 3.0, 6.0 and 9.0 ml/kg body weight in albino rabbits. Duration of observation period following administration: 14 days, growth, food and water intake, haematology and gross pathology were examined. No mortality occurred, slight skin effects were seen at 3.0 and 6.0 ml/kg and slight to moderate skin effects at 9.0 ml/kg. Gross examination at autopsy did not reveal any clearly treatment-related changes. Under the conditions of the test, the dermal LD50 was > 9 mL/kg bw (which corresponds to > 8.856 g/kg bw). Therefore, the criteria laid down in Annex I of the CLP Regulation (1272/2008/EC) are not fullfilled and the substance does not need to be classified for acute toxicity.
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.
