Registration Dossier
Registration Dossier
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EC number: 260-070-5 | CAS number: 56235-92-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 4 August 1982
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- Study conducted outside the EU over 10 years before the EU cosmetic testing ban came into effect.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Code of Federal Regulations 16, Part 1500.3 (USA)
- GLP compliance:
- no
- Test type:
- fixed dose procedure
Test material
- Reference substance name:
- Bis(2-ethylhexyl) malate
- EC Number:
- 260-070-5
- EC Name:
- Bis(2-ethylhexyl) malate
- Cas Number:
- 56235-92-8
- Molecular formula:
- C20H38O5
- IUPAC Name:
- 1,4-bis(2-ethylhexyl) 2-hydroxybutanedioate
- Test material form:
- liquid
- Details on test material:
- Identification: Dermol DOM
Appearance: Clear colourless to pale yellow liquid
Batch: P7677
Purity/Composition: >95%
Test item storage: At room temperature
Stable under storage conditions until: 31 December 2018 (retest date)
Additional information
Test Facility test item number: 209081/A
Purity/Composition correction factor: No correction factor required
Test item handling: No specific handling conditions required
Molecular structure: Not indicated
Molecular formula: C20H38O5
Molecular weight: 358.5
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: albino
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Not detailed
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Animals were observed for pharmacologic activity and drug toxicity 1,3,6 and 24 hours after treatment, and daily thereafter for a total of 14 days.
- Doses:
- 5 grams per kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 other: g/kg
- Mortality:
- two animals died during the study
- Clinical signs:
- other: not reported
- Gross pathology:
- Not reported
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- 20% of the animals used at the dose level of 5g/kg died. LD50 is greater than 5ml/kg
- Executive summary:
In this guideline (CFR 1500.3) study the LD50 of the test material was determined to be 5g/kg bw. 5 male and 5 female rats were dosed orally by gavage at 5g/kg and observed for 2 weeks post-dose. 2 deaths were observed.
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