Reaction mass of 6-ethyl-3-methyloct-5-en-1-ol and 6-ethyl-3-methyloct-6-en-1-ol

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study, to GLP.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2014

Report date:

2014

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6-ethyl-3-methyloct-5-en-1-ol

EC Number:

247-615-2

EC Name:

6-ethyl-3-methyloct-5-en-1-ol

Cas Number:

26330-64-3

Molecular formula:

C11H22O

IUPAC Name:

6-ethyl-3-methyloct-5-en-1-ol

Constituent 2

Reference substance name:

247-615-2 & 247-616-8

IUPAC Name:

247-615-2 & 247-616-8

Test material form:

other: liquid

Details on test material:

Test article identification: Super Muguet
Batch number: SC00011582
CAS Number: 26330-64-3
EC number: 247-615-2 & 247-616-8
Molecular formula: C11H22O
Molecular weight: 170.30 g/mol
Expiration date: 20 June, 2016
Appearance: Clear, colourless liquid
Purity: 98.27 %
Storage conditions: Sealed container, 15 to 30 deg C, in the dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

Female (nulliparous, non-pregnant) Crl:WI(Han) strain rats were obtained from Charles River UK Ltd., Margate. All animals were given a clinical inspection for ill health on arrival and a sample was weighed.
Rats were arbitrarily selected from the delivery boxes and allocated to the appropriate number of cages using a sequence that reduced selective bias. The condition of the animals was assessewd daily throughout the acclimatisation period of 14 to 16 days. A second inspection was performed prior to the study commencement to ensure the animals were suitable for the study. Overtly healthy animals were arbitrarily allocated study groups at least one day prior to dosing.
At the start of the study the rats were 9 to 10 weeks of ages. The weight variation did not exceed ± 20% of the mean weight.
- Housing: The animals were housed in groups of up to 5 during the acclumatisation period in cages that conform to the 'Code of Practice for the Housing and Care of Animals Used in Scientific Procedures' (Home Office, London, 1989). From the day prior to dosing (Day -1), the rats were housed in groups of 3 in similar cages.
Bedding was provided on a weekly basis to each cage by use of clean European sofe wood bedding (Datesand Ltd, Manchester, UK).
Each atch of bedding was analysed for specific constituents and contaminants. No contaminants werre present in the bedding at levels which might have interfered with achieving the objective of the study.
- Water: Mains water was provided ad libitum via cage mounted water bottles. Yje water was periodically analysed for specific contaminants.
No contaminants were present in the water at levels which mighthave interfered with achieving the objective of the goal.
- Diet: Throughout the study the animals had access to SQC(E) Rat and Mouse Maintenance Diet No. 1, from Special Diets Services Ltd., Witham, UK which was freely available to the animals at all times, except for a period of fasting from the evening of the day prior to dosing (Day -1) until approximately 3 hours after dosing. Each batch of diet had been analysed for specific constituents and contaminants. No contaminants werre present in the bedding at levels which might have interfered with achieving the objective of the study.
- Environment: The animal rooms were designed to permit 15 to 20 air changes per hour. The target temperature and humidity were 20 to 24 °C and 45 to 65% respectively. Daily recordings of maximum and minimum temperature and humidity were made.
Fluorescent lighting was controlled automatically to give a cycle of 12 hours light and 12 hours dark.
- Environmental Enrichment: In order to enrich both the environment and the welfare of the animals, they were provided with wooden Aspen chew blocks and rodent retreats.
- Animal Identification: A number written on the tail in indelible ink on the day before dosing individually identified the rats. A colour coded card on each cage gave information including study number, group number, animal numbers and sex.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

The test article was used as supplied. The specific gravity was determined and used to calculate the appropriate does volume for the required does level. Dose containers were repeatedly inverted prior to the administration to ensure homogeneity.

Doses:

A limit test at one dose level of 2000 mg/kg was carried out with six animals (three animals per step).

No. of animals per sex per dose:

Six

Control animals:

no

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:

other: No clinical signs were seen.

Gross pathology:

No abnormalities were noted at necropsy of animals killed at the end of the study.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Remarks:

Migrated information

Conclusions:

The acute median lethal oral dose level of the test article, Super Muguet, was found to exceed 2000 mg/kg.
The test material was considered to have no significant acute toxic risk in respect of its acute oral toxicity and did not meet the criterea for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS).