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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:
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:
1996
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

Constituent 1
Chemical structure
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

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.