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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
06 Nov - 05 Dec 2007
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study. According to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Ministerium für Umwelt und Naturschutz, Landwirtschaft und Verbraucherschutz des Landes Nordrhein-Westfalen, Düsseldorf, Germany
Test type:
acute toxic class method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
97593-30-1 (C12)
IUPAC Name:
97593-30-1 (C12)
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Chemical name: Acetylided glyceride-mixture
- Physical state: yellowish fluid
- Analytical purity: 99.8%
- Lot/batch No.: CH70920C
- Expiration date of the lot/batch: 20 Sep 2008
- Stability under test conditions: the analytical data on stability verified that the test compound formulations were stable at room temperature for at least 4 h.
- Storage condition of test material: at room temperature

Test animals

Species:
rat
Strain:
other: HsdCpb:Wu
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan/Winkelmann GmbH, Borchen, Germany
- Age at study initiation: approx. 9-12 weeks
- Weight at study initiation: 165-189 g
- Fasting period before study: 16-24 h
- Housing: the animals were caged conventionally in polycarbonate cages on low dust wood granulate bedding. The cages of the animals were placed on racks. The wood granulate was randomly checked for contaminants at regular intervals. The analyses yielded no evidence of any adverse effects on the aim of the study. The cages were changed at least once a week. Feed racks and water bottles were not changed. All cage material was washed with hot water. In the first stage of the washing programs, an alkaline cleaning agent was used.
The animal room was provided with sound from a radio program.
- Diet: standard diet Provimi Kliba 3883 PM S15 Maus/Ratte Haltung (Provimi Kliba, Kaiseraugst, Switzerland), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 5
- Air changes (per hr): approx. 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 200 mg/mL
- Amount of vehicle (if gavage): 10 mL/kg bw

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw

DOSAGE PREPARATION: For oral administration, the test substance was formulated in corn oil. The applied formulations were well mixed before administration. The formulations for administration were prepared at room temperature.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
6 (3 per step)
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs and mortality rates were determined several times on the day of administration and subsequently at least once daily through the end of the observation period. The weight gain of the animals was checked weekly until the end of the study.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: experimental result
Sex:
female
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: LD50 cut-off according to OECD 423
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs were observed.
Body weight:
There were no toxicologically significant effects on body weight or body weight gain.
Gross pathology:
The necropsies performed at the end of the study revealed no treatment-related findings.

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