Reaction Mass of (1R)-1-[(1S)-3,3-dimethylcyclohexyl]ethyl formate and (1R,2S)-2,6,6-trimethylcycloheptyl formate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

29 Jan 1982 to 12 Feb 1982

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction Mass of (1R)-1-[(1S)-3,3-dimethylcyclohexyl]ethyl formate and (1R,2S)-2,6,6-trimethylcycloheptyl formate

EC Number:

939-618-9

Cas Number:

25225-08-5

Molecular formula:

C11H20O2

IUPAC Name:

Reaction Mass of (1R)-1-[(1S)-3,3-dimethylcyclohexyl]ethyl formate and (1R,2S)-2,6,6-trimethylcycloheptyl formate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals
- Weight at study initiation: 235-287 g
- Fasting period before study: 16-20 hours
- Housing: 5/cage in suspended wire mesh cages. Bedding was placed beneath the cages.
- Diet: fresh Purina Rat Chow (Diet #5012), ad libitum, except 16-20 hours prior to dosing
- Water: ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Photoperiod (hrs dark / hrs light): 12 / 12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Doses:

5.0 g/kg bw

No. of animals per sex per dose:

10 males/dose

Control animals:

no

Details on study design:

- Observations: Animals were observed 3-4 hours post dosing and once daily thereafter for 14 days for mortality, toxicity and pharmacological effects.
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: Clinical signs included chromorhinorrhea (9 animals), ptosis (7 animals), chromodacryorrhea (7 animals), emaciation (3 animals), lethargy (3 animals), piloerection (3 animals), diarrhea (1 animal), yellow nasal discharge (1 animal) and respiratory rattle

Gross pathology:

All animals were normal.

Applicant's summary and conclusion

Interpretation of results:

other: Not harmful

Remarks:

In accordance with EU CLP (EC no 1272/2008 and its amendments)

Conclusions:

The acute oral LD50 in rats was determined to be > 5000 mg/kg bw in a study performed similar to OECD TG 401.

Executive summary:

An acute oral toxicity study with the substance was conducted in rats, according to a protocol similar to OECD TG 401 and in compliance with GLP. Ten male Wistar rats received a single dose of 5000 mg/kg bw by gavage. Animals were observed for 14 days and necropsied. There were no deaths. Main clinical signs were chromorhinorrhea, ptosis and chromodacryorrhea. No findings were observed at gross pathology. Based on the results of the study, the LD50 was > 5000 mg/kg bw.