(E)-1-(2,4,4-trimethyl-2-cyclohexen-1-yl)-2-buten-1-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

22 Aug - 13 Sep 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

24 Feb 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

EEC directive 92/69/EEC (July 31, 1992)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Niedersächsisches Umweltministerium, Hannover, Germany

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(E)-1-(2,4,4-trimethyl-2-cyclohexen-1-yl)-2-buten-1-one

EC Number:

254-663-8

EC Name:

(E)-1-(2,4,4-trimethyl-2-cyclohexen-1-yl)-2-buten-1-one

Cas Number:

39872-57-6

Molecular formula:

C13H20O

IUPAC Name:

(E)-1-(2,4,4-trimethyl-2-cyclohexen-1-yl)-2-buten-1-one

Test animals

Species:

rat

Strain:

other: Hsd/Cpb:WU

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Females nulliparous and non-pregnant: not specified
- Weight at study initiation: 230 - 252 g (males) and 155 - 171 g (females)
- Fasting period before study: 16 h before administration and 3 -4 h after administration
- Housing: up to 5 animals per cage per sex, in Makrolon type III cages on LIGNOCEL bedding
- Diet: pelleted rat diet (Ssniff R-Alleindiät, Ssniff Spezialdiäten GmbH, Soest, Germany), ad libitum
- Water: drinking water, ad libitum
- Acclimation period: 6 days (range-finding study), 7 days (main study, females), 14 days (main study, males)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 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: 2.11 mL/kg bw

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

Range-finding test: 2 females
Main study: 5 males and 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were examined 10 min, 1 h, 2 h, 6 h and 24 h after treatment and thereafter once daily up to Day 14. Body weights were recorded immediately before treatment (Day 0) and on Days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, gross pathology

Results and discussion

Preliminary study:

No mortility occured in the range-finding test.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

1/5 males and 0/5 females died

Clinical signs:

other: slight diarrhea in 5/5 males 24 h after treatment, fully reversible on Day 3; slight squatting position and slight piloerection in 1/5 female 24 h after treatment, fully reversible within 48 h.

Gross pathology:

In the animal found dead, test substance related findings of extreme redness of the gastric mucous membrane was observed.
In surviving animals, an adhesion of the stomach to other organs was found, mainly to the spleen which was enlarged in most animals. Additionally, particles of probably separated and indurated tissue portions were observed in the stomach.

Any other information on results incl. tables

Table 1. Results of the acute oral toxicity study in rats.

Dose level (mg/kg bw)	Mortalities	Clinical signs
males
2000	1/5	5/5
females
2000	0/5	1/5

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 male and female rats a LD50 value of > 2000 mg/kg bw was found.