Registration Dossier
Registration Dossier
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EC number: 947-486-9 | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980-07-31 to 1980-08-14
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study result presented as summary but includes all relevant information. Study was performed prior to implementation of GLP but carried out according to the principles of GLP.
Cross-reference
- Reason / purpose for cross-reference:
- read-across source
Reference
- Endpoint:
- acute toxicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- other information
- Justification for type of information:
- Justification for the read-across from the introduced read-across supporting substance (CAS 67938 -21 -0) to the registration substance:
The introduced read-across supporting substance (CAS 67938-21-0) is structurally related to the registration substance. Both substances are fatty acid esters of polyglycerols, the only diffence being that the introduced read-across source substance (CAS 67938-21-0) is synthesized by using isostearic acid as fatty acid while the registration substance by using stearic acid.
Both substances are expected to undergo enzymatic hydrolysis resulting into the release of polyglyerols and the corresponding fatty acids (isostearic acid for the read-across supporting substance and the stearic acid for the registration substance. Isostearic acid as well as the stearic acid are well-investigated substances and occurs also endogenously. No difference in the acute oral toxicity can be reliably derived. - Reason / purpose for cross-reference:
- assessment report
- Interpretation of results:
- GHS criteria not met
- Executive summary:
No classification is warranted for the registration substance based on the read-across data.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
- Report date:
- 1980
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Remarks:
- Study was performed prior to implementation of GLP
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Fettsaeurepolyglycerinester
- IUPAC Name:
- Fettsaeurepolyglycerinester
- Reference substance name:
- Di(isooctadecanoic) acid, diester with oxydi(propanediol)
- EC Number:
- 267-821-6
- EC Name:
- Di(isooctadecanoic) acid, diester with oxydi(propanediol)
- Cas Number:
- 67938-21-0
- Molecular formula:
- C42H82O7
- IUPAC Name:
- di(isooctadecanoic) acid, diester with oxydi(propanediol)
- Reference substance name:
- Diglyceryl-diisostearate
- IUPAC Name:
- Diglyceryl-diisostearate
- Test material form:
- other: clear light yellow liquid
- Details on test material:
- - Name of test material (as cited in study report): Hoe S 2721 = Fettsaeurepolyglycerinester
- Physical state: clear light yellow liquid
- Analytical purity:
- Purity test date:
- Lot/batch No.:
- Expiration date of the lot/batch:
- Other:
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- 5000 mg/kg body weight
- No. of animals per sex per dose:
- 10 females
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortallity occurred during the subsequent observation of 14 days.
- Clinical signs:
- other: Minor clinical symptoms, i.e. squatting posture, hair-raising, have been observed, but were reversible within 24 hours post application of test item.
- Gross pathology:
- The animals killed at the end of the observation period showed no macroscopcally visible changes.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the study results, the acute oral toxicity (LD50) of the test substance registered is greater than 5000 mg/kg body weight.
- Executive summary:
Based on the study results, the acute oral toxicity (LD50) of Hoe S 2721 in the rat is greater than 5000 mg/kg body weight. Accordingly Hoe S 2721 is not subject for labelling requirements with regard to acute oral toxicity.
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