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Toxicological information

Acute Toxicity: oral

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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:
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

Constituent 1
Chemical structure
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 levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
> 25 mL/kg bw
Based on:
test mat.
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