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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:
8 May - 22 May 1990
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:
1990
Report date:
1990

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
Glycerides, C14-18 and C16-22-unsatd. mono- and di-
EC Number:
294-574-1
EC Name:
Glycerides, C14-18 and C16-22-unsatd. mono- and di-
Cas Number:
91744-13-7
IUPAC Name:
91744-13-7
Details on test material:
- Name of test material (as cited in study report): only trade name given
- Chemical denomination: Glycerides, C14-18 and C16-22, unsaturated, Mono- and Di-
- Batch No.: 0189-0-040
- Physical state: brownish fluid
- Analytical purity: approximately 100 %

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Weight at study initiation: 180 g (males), 161 g (females)
- Fasting period before study: animals were fasted 16 h prior to administration
- Housing: animals were housed in groups of 5 per cage in Makrolon 3 cages with softwood bedding
- Diet: Altromin Diet 1324 (Altromin GmbH, Lage, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-25
- Humidity (%): 45-60
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: CMC (carboxymethyl cellulose, 1%) + Cremophor (0.5%) in aqua dest.
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20% (g/v)

MAXIMUM DOSE VOLUME APPLIED: 10 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: several times at day of application and subsequently twice daily
- Frequency of weighing: animals were weighted on Day 0, 2, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

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 and histopathological examination revealed no substance-related findings. In one female a bilateral hydrometra was observed, not treatment-related.

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