reaction mass of [(1R*,5S*)-3,3,5-trimethylcyclohexyl] acetate and [(1S*,5S*)-3,3,5-trimethylcyclohexyl] acetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

20 Sep - 7 Oct 2004

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2004

Report date:

2004

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

adopted in Feb 2002

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Version / remarks:

2004/73/EC

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Behörde für Arbeit, Gesundheit und Soziales, Hamburg, Germany

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

reaction mass of [(1R*,5S*)-3,3,5-trimethylcyclohexyl] acetate and [(1S*,5S*)-3,3,5-trimethylcyclohexyl] acetate

EC Number:

946-282-7

Molecular formula:

C11H20O2

IUPAC Name:

reaction mass of [(1R*,5S*)-3,3,5-trimethylcyclohexyl] acetate and [(1S*,5S*)-3,3,5-trimethylcyclohexyl] acetate

Test animals

Species:

rat

Strain:

other: Crl:CD

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at start of adaptation: 40 days (males), 47 days (females)
- Weight at study initiation: 192 - 206 g (males), 171 - 190 g (females)
- Fasting period before study: animals were fasted 16 h prior to administration
- Housing: groups of 3 animals in MAKROLON cages (type III), granulated textured wood was used as bedding material
- Diet: ssniff R/M-H V1534 (ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum, analysis was performed
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 40 - 70
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 2.17 mL/kg bw

Doses:

2000 mg/kg bw (step 1 and 2)

No. of animals per sex per dose:

3 males (step 1) and 3 females (step 2)

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed before and immediately 5, 15, 30 and 60 min, as well as 3, 6 and 24 hours after administration. During the follow-up period of two weeks, changes of skin and fur, eyes and mucous membranes, respiratory and the circulatory, autonomic and central nervous system and somatomotor activity as well as behaviour pattern were observed at least once a day until all symptoms subsided, thereafter each working day. Attention was also paid to possible tremor, convulsions, salivation, diarrhoea, lethargy, sleep and coma. Observations on mortality were made at least once daily.
Individual body weights were determined before administration of the test substance and thereafter in weekly intervals. Changes in weight was calculated when survival exceeded one day.
- Necropsy of survivors performed: yes
- Other examinations performed: From animals which survive 24 h or longer a microscopic examination of all organs which showed evident lesions was performed, if necessary.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: LD50 cut-off of 5000 mg/kg bw according to OECD 423

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: No signs of toxicity were observed up to the end of the 14-day observation period.

Gross pathology:

No pathological findings were noted at necropsy.

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 > 2000 mg/kg bw was found.

Executive summary:

Under the present test conditions a single oral administration of 2000 mg Mintonat/kgb.w. rats did not reveal any signs of toxicity. Mortality did not occur, all male and female animals gained the expected body weight at the end of the study.