Registration Dossier
Registration Dossier
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 429-460-4 | CAS number: 7078-98-0
Toxicological information
Acute Toxicity: oral
Currently viewing:
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:
- 1 998
- 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
- 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
Constituent 1
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
