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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Sep 1970
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Basic data given. High administration volume, few details on the test protocol were given, no individual data was given, 7-day observation period in the absence of mortality/clinical signs, the analytical purity of the test substance was not speciified.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1970
Report Date:
1970

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
high administration volume, few details on test protocol given, no individual data, 7-day observation period in the absence of mortality/clinical signs
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Isononanoic acid, C16-18-alkyl esters
- Analytical purity: no data
- Other: pH approximately 5

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 144 g (mean)

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 50% or undiluted test substance

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
10 and 19.9 mL/kg bw
(equivalent to 8.55 and 17.01 g/kg bw, as calculated from mean density 0.8548 g/cm³, Cognis 2010)
No. of animals per sex per dose:
10 males per dose group
Control animals:
no
Details on study design:
- Duration of observation period following administration: 7 days
- Other examinations performed: clinical signs

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
> 19.9 mL/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
> 17 010 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Calculated from a mean density of 0.8548 g/cm³ (Cognis, 2010)
Mortality:
No mortality occurred during the study period.
Clinical signs:
No clinical signs of systemic toxicity were observed during the study period.

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