Registration Dossier
Registration Dossier
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EC number: 212-990-3 | CAS number: 903-19-5
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 04 Oct - 07 Nov 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- Annex to Directive 92/69/EEC (OJ No. L383A, 29,12,92), Part B, Method B.1)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- Adopted 17 Dec 2001.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Good Laboratory Practice, The United Kingdom Compliance Programme, Department of Health and Social Security 1986 and subsequent revision, Department of Health, UK
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
- EC Number:
- 212-990-3
- EC Name:
- 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
- Cas Number:
- 903-19-5
- Molecular formula:
- C22H38O2
- IUPAC Name:
- 2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Remarks:
- Hsd/Ola: Sprague-Dawley (CD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Olac Ltd., Bicester, Oxon, UK
- Females: yes
- Age at study initiation: 4 - 7 wks
- Weight at study initiation: 94 - 100 g (males range), 99 - 105 g (females range)
- Fasting period before study: animals were fasted overnight prior to and approximately 4 hours after dosing
- Housing: groups of up to 5 rats of the same sex per cage, in metal cages with mesh floors
- Diet: SDS LAD 1, ad libitum
- Water: drinking water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 24 Oct 1995 To: 07 Nov 1995
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- 1%, aqueous
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% w/v
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: limit test in compliance with Test Guideline OECD420. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for mortality, morbidity and clinical signs soon after dosing and at frequent intervals on Day 1, then twice daily for 14 days. The bodyweight of each rat was recorded on Day 1 (prior to dosing), 8 and 15.
- Necropsy of survivors performed: yes - Statistics:
- Individual weekly bodyweight changes and group mean bodyweights.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: 2000 mg/kg bw: piloerection was observed in all rats within 5 min of dosing, recovery was complete in all instances by three hours after dosing. There were no other clinical signs.
- Gross pathology:
- No macroscopic abnormalities were observed for animals killed on Day 15.
Any other information on results incl. tables
Dose [mg/kg bw] |
Mortality |
Clinical Signs |
N |
N |
|
Males |
||
2000 |
0/5 |
5/5 |
Females |
||
2000 |
0/5 |
5/5 |
N = Number of animals dosed
Clinical Signs = Piloerection was observed in all rats, completely resolving in all instances by 3 hours after dosing
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- The acute lethal oral dose (LD50) to rats of AF-317 was found to be greater than 2000 mg/kg bw.
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