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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
07 Dec - 26 Mar 1999
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with acceptable restrictions (no data on analytical purity).

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1999
Report date:
1999
Reference Type:
secondary source
Title:
Test Plan for the polyol esters category of the aliphatic esters chemicals
Author:
US-EPA (American Chemistry Council’s Aliphatic Esters Panel)
Year:
2004
Bibliographic source:
High Production Volume (HPV)

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Version / remarks:
adopted in 1992
Deviations:
yes
Remarks:
no data on analytical purity
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Fatty acids, C5-9, hexaesters with dipentaerythritol
EC Number:
267-021-7
EC Name:
Fatty acids, C5-9, hexaesters with dipentaerythritol
Cas Number:
67762-52-1
IUPAC Name:
67762-52-1
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Physical state: pale yellow liquid
- Analytical purity: no data
- Lot/batch No.: CRU 98433
- Expiration date of the lot/batch: 05 Nov 2003
- Storage condition of test material: room temperature
- Other: Density: 1.0 g/mL

Test animals

Species:
rat
Strain:
other: Albino Rats (Outbred). Stock: Sprague-Dawley – derived (CD ®) [Crl: CD ® (SD) IGS BR]
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Kingston, New York, USA
- Age at study initiation: 9-12 weeks
- Weight at study initiation: 279 – 318 g (males); 204 – 219 g (females)
- Fasting period before study: animals were fasted overnight prior to administration
- Housing: 2 – 6/ cage during acclimation. Individually housed in suspended and stainless steel cages with wire mesh bottoms during study.
- Diet: Certified Rodent Diet, No. 5002, ad libitum
- Water: automatic watering system, ad libitum.
- Acclimation period: 15 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 – 24
- Humidity (%): 30 – 70
- Photoperiod (hrs dark / hrs light): 12 / 12



Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 2.0 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: mortality was observed twice daily for 14 days. Clinical signs were observed several times on the day 1, and daily until day 14. Body weights were measured on day 0 (at time of fasting), 1 (just prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes (on day 15)
- Other examinations performed: clinical signs, body weight, food consumption, gross pathology and histopathology

Results and discussion

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:
other: No clinical signs of toxicity were observed up to the end of the 14-day observation period.
Gross pathology:
Necropsy examination revealed no substance-related findings.
Other findings:
- Histopathology: there were no treatment-related effects on histopathology.

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