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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:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Cross-reference
Reason / purpose:
reference to same study
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1971
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
See read across justification document attached in section 13.2
Reason / purpose:
read-across source
Related information:
Composition 1
Reference:
Composition 0
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute oral toxicity study
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
Test material information:
Composition 1
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Fasting period before study: 16 h
TEST ANIMALS
- Weight at study initiation: 150 - 208 g
- Acclimation period: 5 d before beginning of study
- Housing: stock cages
- Housing after dosing: individually in wire-mesh cages
- Food and water: ad libitum
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
dose levels ranging from 0.6 – 23.1 g/kg
3.0, 4.6, 6.8, 10.2 g/kg bw
No. of animals per sex per dose:
2 per dose
Control animals:
other: not applicable
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, initial and final body weight
Statistics:
Weil and Thompson methods
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
6 800 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Standard deviation: +/- 800 mg/kg bw
Mortality:
3.0 g/kg bw: 0/4 deaths
4.6 g/kg bw: 0/4 deaths
6.8 g/kg bw: 2/4 deaths
10.2 g/kg bw: 4/4 deaths
Clinical signs:
3000 mg/kg: hypoactivity, ruffed fur
4600 mg/kg bw: hypoactivity, ruffed fur, muscular weakness
6800 mg/kg bw: hypoactivity, muscular weakness, prostration, diarrhea, ruffed fur
10200 mg/kg bw: hypoactivity, muscular weakness, prostration, diarrhea, ruffed fur
Body weight:
Not specified
Gross pathology:
Animals sacrificed: no gross findings
Animals found dead: gastroenteritis, pale livers, pale kidneys, hemorrhages in the stomachs
Interpretation of results:
GHS criteria not met
Conclusions:
According to this study, the LD50 observed after an exposure of the test substance on rats (male/female) was 6.8 g/kg bw.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Acute oral toxicity study
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
Designation: CITRONELLYL ACETATE EXTRA
Appearance: colourless to pale yellowish liquid
Specific details on test material used for the study:
CAS number: 150-84-5

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Fasting period before study: 16 h
TEST ANIMALS
- Weight at study initiation: 150 - 208 g
- Acclimation period: 5 d before beginning of study
- Housing: stock cages
- Housing after dosing: individually in wire-mesh cages
- Food and water: ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
dose levels ranging from 0.6 – 23.1 g/kg
3.0, 4.6, 6.8, 10.2 g/kg bw
No. of animals per sex per dose:
2 per dose
Control animals:
other: not applicable
Details on study design:
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, clinical signs, initial and final body weight
Statistics:
Weil and Thompson methods

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
6 800 mg/kg bw
Based on:
test mat.
Remarks on result:
other: Standard deviation: +/- 800 mg/kg bw
Mortality:
3.0 g/kg bw: 0/4 deaths
4.6 g/kg bw: 0/4 deaths
6.8 g/kg bw: 2/4 deaths
10.2 g/kg bw: 4/4 deaths
Clinical signs:
3000 mg/kg: hypoactivity, ruffed fur
4600 mg/kg bw: hypoactivity, ruffed fur, muscular weakness
6800 mg/kg bw: hypoactivity, muscular weakness, prostration, diarrhea, ruffed fur
10200 mg/kg bw: hypoactivity, muscular weakness, prostration, diarrhea, ruffed fur
Body weight:
Not specified
Gross pathology:
Animals sacrificed: no gross findings
Animals found dead: gastroenteritis, pale livers, pale kidneys, hemorrhages in the stomachs

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to this study, the LD50 observed after an exposure of the test substance on rats (male/female) was 6.8 g/kg bw.