Glycerides, C14-18 and C16-18-unsatd. mono-, di- and tri-

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:

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

Test material information

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