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Toxicological information

Acute Toxicity: oral

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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Version / remarks:
adopted on 24th February 1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
Deviations:
no
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

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
429-460-4
EC Name:
-
Cas Number:
7078-98-0
Molecular formula:
C21 H26 O
IUPAC Name:
2,6-di-tert-butyl-4-(phenylmethylidene)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