2,6-dimethyloct-7-en-2-yl formate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

02 January 2018 - 02 February 2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,6-dimethyloct-7-en-2-yl formate

EC Number:

246-788-1

EC Name:

2,6-dimethyloct-7-en-2-yl formate

Cas Number:

25279-09-8

Molecular formula:

C11H20O2

IUPAC Name:

2,6-dimethyloct-7-en-2-ol

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Remarks:

RccHan: WIST

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Jai Research Foundation
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 8 to 10 weeks
- Weight at study initiation: 164.6-188.2 g
- Fasting period before study: Overnight and until 3 h post dosing.
- Housing: Two rats per cage.
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 6-11 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-23 ºC
- Humidity (%): 49-67 %
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12 (lights hours 06:00 h – 18:00 h)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 0.44 mL

DOSAGE PREPARATION (if unusual): Individual dose volume was adjusted according to body weight and dose level and density (852.7 mg/mL).

Doses:

Sighting test: 300 and 2000 mg/kg bw
Main test: 2000 mg/kg bw

No. of animals per sex per dose:

Sighting test: 2 rats
Main test: 4 rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Signs of toxicity: 0.5, 1, 2, 3, 4 and 6 h post-administration
Morbidity and mortality: twice a day thereafter
Clinicals signs: Once a day
Weighing: Days 0, 7 and 14
- Necropsy of survivors performed: yes (external examination and opening of the abdominal and thoracic cavities)

Results and discussion

Preliminary study:

A sighting study was conducted using two animals; the first animal was dosed at the dose level of 300 mg/kg body weight. As no toxic sign or mortality was observed at this dose level, another animal was dosed at the higher dose level of 2000 mg/kg body weight. Nno toxic sign or mortality was observed.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

>= 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No clinical sign was observed.

Clinical signs:

other: No clinical sign was observed.

Gross pathology:

External examination of terminally sacrificed rats did not reveal any abnormality of pathological significance.
Visceral examination of terminally sacrificed rats did not reveal any lesion of pathological significance.

Any other information on results incl. tables

Dose (mg/kg bw)	Study	Rat N°	Volume of Dose Administered (mL)	Body Weight (g) on Day			Percent Body Weight Change on Day
				0	7	14	7	14
300	Sighting	1	0.06	164.6	180.4	208.2	9.6	26.5
2000	Sighting	2	0.40	170.4	195.4	209.2	14.7	22.8
	Main	3	0.44	188.2	211.1	221.2	12.2	17.5
		4	0.43	185.1	200.5	214.5	8.3	15.9
		5	0.44	188.1	225.4	232.8	19.8	23.8
		6	0.42	180.2	202.1	216.4	12.2	20.1

Applicant's summary and conclusion

Interpretation of results:

Category 5 based on GHS criteria

Conclusions:

The acute oral median lethal dose (LD50) of test item in Wistar rats was found to be greater than 2000 mg/kg body weight.

Executive summary:

An acute oral toxicity test was performed according to OECD Guideline 420 (GLP study). A sighting study was conducted using two animals; the first animal was dosed at the dose level of 300 mg/kg body weight. As no toxic sign or mortality was observed at this dose level, another animal was dosed at the higher dose level of 2000 mg/kg body weight. As no toxic sign or mortality was observed, a main study (limit test) was conducted by dosing further four animals at the same dose level. No toxic signs or mortality was observed in main study conducted at the dose level of 2000 mg/kg body weight. There were no treatment-related mortality, clinical sign, changes in body weight or necropsy findings recorded. The acute oral median lethal dose (LD50) of test item in Wistar rats was found to be greater than 2000 mg/kg body weight