Glycerides, C8-10 mono- and di-

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

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given. Lack of details on experimental conditions and on test substance. No necropsy was performed.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

yes

Remarks:

lack of details on experimental conditions and on test substance; no necropsy was performed

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Glycerides, mixed decanoyl and octanoyl

EC Number:

277-452-2

EC Name:

Glycerides, mixed decanoyl and octanoyl

Cas Number:

73398-61-5

Molecular formula:

C27H50O6 to C33H62O6

IUPAC Name:

Glycerides, mixed decanoyl and octanoyl

Details on test material:

- Name of test material (as cited in study report): only trade name given
- Physical state: straw-coloured clear liquid
- Analytical purity: no data

Test animals

Species:

mouse

Strain:

other: Tyler's Original Strain

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bantin and Kingman Ltd., Yorks, UK
- Weight at study initiation: 20 ± 4 g
- Fasting period before study: animals were fasted overnight prior to administration.
- Housing: solid-floor polycarbonate cages
- Diet: Standard Laboratory Diet, 41B (Dixon and Sons Ltd., Herts, UK), ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- 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: 25 mL/kg bw

Doses:

12.5, 20 and 25 mL/kg bw
(equivalent to 11812.5, 18900 and 23625 mg/kg (Density 945 - 949 mg/cm³))

No. of animals per sex per dose:

10

Control animals:

other: not required

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed daily for signs of toxicity and mortality. Body weights were determined daily during the study period.
- Necropsy of survivors performed: no
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Effect levels 1

Sex:

female

Dose descriptor:

LD50

Effect level:

> 25 mL/kg bw

Based on:

test mat.

Effect levels 2

Sex:

female

Dose descriptor:

LD50

Effect level:

> 23 625 mg/kg bw

Based on:

test mat.

Mortality:

Deaths occurred within 24-48 h in the 20 and 25 mL/kg dose groups. All survivors appeared asymptomatic by Day 3, although certain individuals did showed a slight loss in weight at Day 7. No further details given.

Clinical signs:

other: Ataxia, lethargy, dyspnoe and diuresis were exhibited within 15 min of administration of the test substance. Complete loss of activity was shown in several animals within 2 h, although other individuals were found to become more active by this time.

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