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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:
27 March 2012 and 19 April 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Qualifier:
according to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): (z)-hex-3-enyl acetate, LEAC
- Substance type: no data
- Physical state: Clear colourless liquid
- Analytical purity: 98.45 %
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: no data
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: 1Z00151
- Expiration date of the lot/batch: 13 June 2015
- Stability under test conditions: no data
- Storage condition of test material: room temperature in the dark under nitrogen

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories UK Ltd, Oxon, Uk
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: the bodyweight variation did not exceed ± 20 % of the bodyweight if the initially dosed animal
- Fasting period before study: over night before dosing and for approximately 3 to 4 hr after dosing
- Housing: The animals were housed in groups of up to 4 in suspended solid-floor polypropylene cages furnished with woodflakes. The animals were provided with environmental enrichment items.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Doses:
2000 mg/kg
No. of animals per sex per dose:
5/sex/dose
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: ½, 1, 2 and 4 hr after dosing and subsequently once daily for 14 d. Morbidity and mortality checks were made daily.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
There were no deaths
Clinical signs:
Decreased respiratory rate was noted 1 and 2 d after dosing in the initial treated animal. There were no signs of systemic toxicity noted in the remaining animals.
Body weight:
All animals showed expected gains in bodyweight over the observation period.
Gross pathology:
A cavity in the right kidney, which was considered to be a genetic defect and not test item related, was noted at necropsy of 1 animal. No abnormalities were noted at necropsy of the remaining animals.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute toxicity of the test item was assessed via the oral route according to OECD guideline 420. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.