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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:
key study
Study period:
02.02.1988 - 16.02.1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
GLP - Guideline study, tested with the source substance CAS 111-11-5. 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:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl octanoate
EC Number:
203-835-0
EC Name:
Methyl octanoate
Cas Number:
111-11-5
Molecular formula:
C9H18O2
IUPAC Name:
methyl octanoate
Details on test material:
- Name of test material (as cited in study report): C8 Methyl Caprylate, 90-100%
- Physical state: liquid, colourless

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Winkelmann GmbH, Germany
- Weight at study initiation: Mean weights: Male: 185 g, Female: 164 g
- Housing: Makrolon Type 3 cages
- Fasting period before study: 16 h before until 3 h after dosing
- Diet (e.g. ad libitum): ad libitum (Altromin Maintainance diet 1324)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 d


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

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 20% (g/v)
- Amount of vehicle (if gavage): 10 mL/kg

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Maximum dose recommended
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 and weighing: clinical observations were done twice daily, weighing on days -1, 1, 2, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross pathology
Statistics:
Not applicable

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Remarks on result:
other: rat
Mortality:
No mortality
Clinical signs:
other: No clinical signs of toxicity
Gross pathology:
No macroscopic findings

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU