Registration Dossier
Registration Dossier
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EC number: 249-044-4 | CAS number: 28472-97-1
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 9 Nov - 29 Nov 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study with acceptable restrictions (test substance purtiy not given)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- , lack of details on test substance
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Niedersächsisches Umweltministerium, Hannover, Germany
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Diisodecyl azelate
- EC Number:
- 249-044-4
- EC Name:
- Diisodecyl azelate
- Cas Number:
- 28472-97-1
- Molecular formula:
- Main component: C29H56O4
- IUPAC Name:
- C9-11 branched alcohols , C10 rich diesters with nonanedioic acid
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: clear yellow liquid
- Analytical purity: no data
- Density: 0.92 g/mL
- Storage: at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Bor: WISW (SPF cbp)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Winkelmann, Borchen, Germany
- Age at study initiation: no data
- Weight at study initiation: males: 222-240 g, females: 161-181 g
- Fasting period before study: from 16 h before until 3-4 h after administration
- Housing: up to 5 animals per Makrolon type III cage on sterilised soft wood bedding.
- Diet: Ssniff-R Alleindiät, Ssniff Spezialdiäten GmbH, Soest, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: 9 - 29 Nov 1993
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.17 mL/kg bw
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: 10 min, 1, 2, 6 and 24 h after application. Thereafter once daily.
- Frequency of weighing: On days 0, 7 and 14 p.a.
- Necropsy of survivors performed: yes, on all animals on day 14.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: No abnormal clinical signs were observed.
- Gross pathology:
- No test-item dependent findings were noted.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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