2,6-bis(1,1-dimethylethyl)-4-(phenylenemethylene)cyclohexa-2,5-dien-1-one

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1998-02-23 - 1998-04-28

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (OECD TG 401) performed under GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

adopted on 24th February 1987

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

429-460-4

EC Name:

-

Cas Number:

7078-98-0

Molecular formula:

C21 H26 O

IUPAC Name:

2,6-bis(1,1-dimethylethyl)-4-(phenylenemethylene)cyclohexa-2,5-dien-1-one

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Boyertown, PA, U.S.A. (on 2/05, 2/10 and 3/03/98)
- Age at study initiation: born the weeks of 12/04/97 through 1/22/98
- Weight at study initiation: 220 - 290 g (males), 224 – 268 g (females)
- Housing: 5/sex/cage in suspended wire cages
- Diet: Fresh Purina Rat Chow ad libitum, except for 16-20 hours prior to dosing
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: temperature-controlled
- Humidity: Not indicated
- Photoperiod: 12 hours dark / 12 hours light

IN-LIFE DATES: From: 1998-02-23 To: 1998-03-25

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE:
- Concentration in vehicle: 0.5 g/mL or 0.2 g/mL, based on dose volume
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: to make dosing by gavage possible
- Purity: no data

Doses:

5000 mg/kg bw; 2000 mg/kg bw (additional group)

No. of animals per sex per dose:

5 rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
Frequency of observations and weighing: 1, 2 and 4 hours postdose and once daily for 14 days for clinical signs and mortality
- Body weights were recorded immediately before administration and on days 7 and 14, at death or at termination in the survivors
- Necropsy of survivors performed: yes

Statistics:

No statistical testing was performed.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

- 1/10 dosed at 5000 mg/kg bw
- 1/10 dosed at 2000 mg/kg bw

Clinical signs:

5000 mg/kg bw:
- Survivors: diarrhea, soiling of the anogenital area, lethargy, bloated abdomen, piloerection, wetness of body areas, brown staining of the nose/mouth area and localized alopecia.
- Male died on day 3: diarrhea, chromodacryorrhea, soiling of the anogenital area, piloerection, lethargy, flaccid muscle tone, brown staining of the nose/mouth area and wetness of the anogenital area.

2000 mg/kg bw:
- Survivors: diarrhea, soiling of the anogenital area, lethargy, brown staining of the nose/mouth area and wetness of the anogenital area
- Male died on day 2: lethargy, dyspnea and soiling of the anogenital area

Body weight:

5000 mg/kg bw: Body weight changes were normal in 7/9 survivors. Two males lost weight by day 3 but gained normally by day 7.
2000 mg/kg bw: Body weight changes were normal in 8/9 survivors. One female lost weight during the 2nd week of the observation period.

Gross pathology:

5000 mg/kg bw: Necropsy results of survivors were normal in 2/9 animals. Localized alopecia was noted in 7/9 animals.
2000 mg/kg bw: Necropsy results of survivors were normal.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU