Hex-3-en-1-yl acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

7 - 28 Jun 2016

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2016

Report date:

2016

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

Version / remarks:

adopted 17 Dec 2001

Deviations:

no

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Hex-3-en-1-yl acetate

EC Number:

911-593-9

Molecular formula:

C8H14O2

IUPAC Name:

Hex-3-en-1-yl acetate

Test animals

Species:

rat

Strain:

other: Crl:CD(SD), SPF

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 8 weeks
- Weight at study initiation: 185.1 - 200.1 g
- Fasting period before study: overnight, approx. 16 h prior and 4 h after dosing
- Housing: 1 animal per cage in stainless wire mesh cages (260W x 350D x 210H mm)
- Diet: Teklad Certified Irradiated Global 18% Protein Rodent Diet 2918C (Envigo RMS. Ltd., USA), ad libitum
- Water: public tap water filtered and irradiated by ultraviolet light, ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.4 - 23.3
- Humidity (%): 44.2 - 59.7
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 400 mg/mL
- Lot/batch no.: MKBV2080V (SIGMA-ALDRICH, Co., USA)

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg bw

CLASS METHOD
- Rationale for the selection of the starting dose: Due to the low expected toxicity of the test substance 2000 mg/kg bw was selected as the starting dose.

Doses:

2000 mg/kg bw (Steps 1 and 2)

No. of animals per sex per dose:

3 females per step

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed 30 min and 1, 2, 4 and 6 h after dosing and thereafter once daily for 14 days. Individual body weights were recorded prior to dosing on Day 0 and on Days 1, 3, 7 and on the day of necropsy, Day 14.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50 cut-off

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: no mortality occurred in Step 1 and 2 at 2000 mg/kg bw in an OECD 423 study

Mortality:

No mortality was observed during the study period.

Clinical signs:

No clinical abnormalities were observed in any animal.

Body weight:

Normal body weight gains were observed in all animals.

Gross pathology:

No grossly visible evidence of morphological abnormalities was observed in any animal.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

In this acute oral toxicity study in rats a LD50 cut-off value of ≥ 5000 mg/kg bw was derived.

Executive summary:

The acute oral toxicity of the test substance was assessed in a study according to OECD Guideline 423 and in compliance with GLP (2016).In this study, no mortality was observed at 2000 mg/kg bw (Steps 1 and 2) in female rats. Thus, a LD50 cut-off value ≥ 5000 mg/kg bw for female rats was derived.