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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:
1972
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Reliability has been presented as 2 because similar to OECD Guideline protocol has been follo wed but not GLP.
Justification for type of information:
The information is used for read across to Pseudo linalyl acetate.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1972
Report date:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
Test was done before GLP came into force.
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Myrcenyl acetate
EC Number:
214-262-0
EC Name:
Myrcenyl acetate
Cas Number:
1118-39-4
Molecular formula:
C12H20O2
IUPAC Name:
2-methyl-6-methylideneoct-7-en-2-yl acetate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200 - 250 gram
- Fasting period before study: a minimum of 16 hours prior to administration of the test material
- Diet: ad libitum
- Water: ad libitum

Administration / exposure

Route of administration:
oral: unspecified
Details on oral exposure:
Test substance was administered as a concentrate.
Doses:
4000, 5000, 6250 and 7800 mg/kg bw
No. of animals per sex per dose:
10 per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations: Observations for mortality were made at 1 and 6 hours after application and thereafter daily.
- Necropsy of survivors performed: Gross necropsies were performed on all survivors.

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
6 300 mg/kg bw
Based on:
test mat.
95% CL:
>= 5 300 - <= 7 300
Mortality:
Dose: Deaths
4000 mg/kg bw: 1/10
5000 mg/kg bw: 3/10
6250 mg/kg bw: 5/10
7800 mg/kg bw: 7/10
Deaths occurred overnight to three days following administration of the drug.
Clinical signs:
The rats experienced piloerection and lethargy.

Applicant's summary and conclusion

Interpretation of results:
other: Not acute harmful
Remarks:
according to EU CLP (EC No. 1272/2008 and its amendments).
Conclusions:
The acute oral toxicity test showed a calculated LD50 of 6300 mg/kg bw.
Executive summary:

Acute oral toxicity: In this study, 40 male rats (10/dose) were administered the substance at dose levels of 4000, 5000, 6250, 7800 mg/kg bw. The test material was administered as a concentrate. At dosage 4000 mg/kg bw 1/10 animals died, at 5000 mg/kg bw 3/10 animals died, at 6250 mg/kg bw 5/10 animals died and at 7800 mg/kg bw 7/10 animals died. The rats experienced piloerection and lethargy. Deaths occurred overnight to three days following administration of the substance. The calculated acute oral LD50 is 6300 mg/kg bw, the 95% confidence limit is 5300-7300 mg/kg bw.

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