Reaction Mass of Cyclohexanepropanol, 2,2,6-trimethyl-a-propyl-, (alpha.R,1R,6S)- and Cyclohexanepropanol, 2,2,6-trimethyl-a-propyl-, (alpha.S,1R,6S)-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From March 11 to April 03, 2014

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

GLP study conducted in compliance with OECD Guideline No. 420 without any deviation.

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:

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

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

Deviations:

no

Principles of method if other than guideline:

Not applicable

GLP compliance:

yes (incl. QA statement)

Remarks:

UK GLP Compliance Programme (inspected on July 10, 2012/ signed on November 30, 2012)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(3R)-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]-3-hexanol

Cas Number:

253454-12-5

Molecular formula:

C15H30O

IUPAC Name:

(3R)-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]-3-hexanol

Constituent 2

Reference substance name:

(3S)-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]-3-hexanol

Cas Number:

253454-10-3

Molecular formula:

C15H30O

IUPAC Name:

(3S)-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]-3-hexanol

Test material form:

liquid

Details on test material:

- Physical state: Colourless liquid
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature, protected from light, in the original container (aluminium bottle)

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Laboratories UK Ltd., Oxon, UK.
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 153-169 g
- Fasting period before study: Animals were fasted for overnight period before administration of test material and for approximately 2-4 h after dosing.
- Housing: Animals were housed in groups of up to 4 in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: Food (2014C Teklad Global Rodent diet supplied by Harlan Laboratories UK Ltd., Oxon, UK), ad libitum
- Water: Mains drinking water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19-25 °C
- Humidity: 30-70 %
- Air changes: 15 changes / h
- Photoperiod: 12 h dark / 12 h light

IN-LIFE DATES: From: March 11, 2014 To: April 03, 2014

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.26 mL/kg bw

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Using available information on the toxicity of the test material, 2000 mg/kg bw was chosen as the starting dose.

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

- Sighting study: 1 female/dose
- Main study: 5 females/dose (1 animal included from sighting study)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Clinical observations were made 0.5, 1, 2 and 4 h after dosing and then daily for up to 14 days. Morbidity and mortality checks were made twice daily. Body weight of each animal was recorded on Day 0 (the day of dosing) and on Days 7 and 14.
- Necropsy of survivors performed: Yes; on completion of the observation period, animals were killed by cervical dislocation and subjected to gross necropsy.

Statistics:

None

Results and discussion

Preliminary study:

- No mortality or clinical sign was observed at 2000 mg/kg bw.

Effect levels

Key result

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality was observed.

Mortality:

- No mortality was observed at 2000 mg/kg bw.

Clinical signs:

other: - No clinical signs were observed at 2000 mg/kg bw.

Gross pathology:

- No abnormalities were observed at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Rat Oral LD50 (females) > 2000 mg/kg bw

Executive summary:

In an acute oral toxicity study (limit test) performed according to OECD Guideline No. 420 and in compliance with GLP, one female Wistar (RccHan™:WIST) rat was administered a single oral dose of test material at 2000 mg/kg bw by gavage (sighting study). Following a sighting study, additional 4 animals were administered a single oral dose of test item at 2000 mg/kg bw (main study). Animals were then observed for mortality, clinical signs and bodyweights for 14 days and at the end of the study the surviving animals were sacrificed for macroscopic examination.

No mortality or clinical signs were observed. All animals showed expected gains in body weight over the 14 day study period. No abnormalities were noted at necropsy.

Rat Oral LD50 (females) > 2000 mg/kg bw

Under the test conditions, the test material is not classified according to the Regulation EC No. 1272/2008 (CLP) and to the GHS.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.