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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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 for cross-reference:
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 for cross-reference:
read-across source
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
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system 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

Constituent 1
Reference substance name:
Citronellyl acetate
EC Number:
205-775-0
EC Name:
Citronellyl acetate
Cas Number:
150-84-5
IUPAC Name:
3,7-dimethyloct-6-en-1-yl acetate
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 or test system 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.