3,7-dimethyl-6-octenyl 2-methylcrotonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6 - 28 Sep 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:

3,7-dimethyl-6-octenyl 2-methylcrotonate

EC Number:

246-426-2

EC Name:

3,7-dimethyl-6-octenyl 2-methylcrotonate

Cas Number:

24717-85-9

Molecular formula:

C15H26O2

IUPAC Name:

3,7-dimethyl-6-octenyl 2-methylcrotonate

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: 185.6 - 202.7 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): 19.0 - 25.0
- Humidity (%): 30.0 - 70.0
- 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
- Lot/batch no.: MKBW9504V (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 starting dose.

Doses:

2000 mg/kg bw (step 1 and step 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

Statistics:

Statistical analysis was not performed. Mean scores and values were determined.

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.

Mortality:

No mortality was observed.

Clinical signs:

other: No clinical abnormalities were observed in any animal.

Gross pathology:

No abnormal morphological findings were 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 found.

Executive summary:

The purpose of this study was to assess the potential toxicity of CITRONELLYL TIGLATE following a single oral dose administration to female Sprague-Dawley rats and to classify the test substance under the category of GHS classification.

Two dose groups of three females were utilized as follows:

Groups 1 and 2 (Steps 1 and 2): 2,000 mg/kg of the test substance

Steps 1−2: A dose of 2,000 mg/kg was administered and then, there was no mortality (Step 1).

A second dose of 2,000 mg/kg was administered (Step 2).

All animals were monitored for clinical signs and body weight changes during the 14-day observation period after administration. They were subjected to a gross necropsy at the end of the observation period.