Registration Dossier
Registration Dossier
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EC number: 286-081-5 | CAS number: 85186-95-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Study period:
- 09 Nov - 25 Nov 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable deviations (Analytical purity not reported)
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)
- Version / remarks:
- adopted in 1987
- Deviations:
- yes
- Remarks:
- Analytical purity not reported
- GLP compliance:
- yes
- Remarks:
- Niedersächsisches Umweltministerium, Hannover, Germany
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with neopentyl glycol
- EC Number:
- 284-957-1
- EC Name:
- Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with neopentyl glycol
- Cas Number:
- 85005-25-0
- IUPAC Name:
- 85005-25-0
- 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
- Storage condition of test material: ambient 20 ± 2 °C
- Other: density 0.91 g/mL
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
- Weight at study initiation: 209-221 g (males); 153-189 g (females)
- Fasting period before study: the animals were fasted from 16 h before until 3 – 4 h after administration of the test article.
- Housing: in groups of a maximum of 5 animals per cage in Makrolon cages type III, bedding from pure soft wood dried, freed from dust and sterilized at 180°C.
- Diet: Ssniff- R Alleindiät, pelleted, ad libitum
- Water: drinking water (drinking bottles) as for human consumption, ad libitum
- Acclimation period: 13 days (range findings); 15 days (main test)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 – 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 09 Nov 1993 To: 25 Nov 1993
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.20 mL/kg
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were examined at the following post-treatment intervals: 10 min, 1 h, 2 h, 6 h, 24 h, and thereafter once daily up to 14 days. Body weights were recorded immediately before treatment (day 0) and on days 7 and 14 post administration (termination).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology
Results and discussion
- Preliminary study:
- During a preliminary range finding test with doses of 2000 mg/kg bw administered to two females no deaths occurred.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- No clinical signs of toxicity were observed up to the end of the 14-day observation period.
- Body weight:
- No effect on body weight was noted.
- Gross pathology:
- Just one dose: necropsy revealed the following findings which were not considered substance-related: urinary retention in urinary bladder in 1/5 males, hyperaemia in lung in 2/5 females and hydrometra in uterus in 1/5 female.
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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