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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:
The study was conducted between 11 July 2000 and 25 July 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
ST 30 C 00
IUPAC Name:
ST 30 C 00
Constituent 2
Reference substance name:
Reaction products of 7-hydroxy-3,7-dimethyloctanal and methyl 2-aminobenzoate
IUPAC Name:
Reaction products of 7-hydroxy-3,7-dimethyloctanal and methyl 2-aminobenzoate
Test material form:
other: clear liquid
Details on test material:
- Name of test material (as cited in study report): ST 30 C 00 (Aurantiol pure - confirmed in RIFM database)
- Physical state: clear liquid
- Lot/batch No.: #AB6271
- Stability under test conditions: expected to be stable for duration of study
- Storage condition of test material: room temperature
- Other: expiry date 18 November 2001

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Inc., Boyer Town, PA, USA
- Age at study initiation: 8-9 weeks
- Weight at study initiation: 182-194 g males and 146-170 g females
- Fasting period before study: 18 hours; feed was returned to the cages approximately 3.5 hours after dosing
- Housing: singly in suspended stainless steel cage with mesh floor
- Diet (e.g. ad libitum): ad libitum Purina Rodent Chow #5012 (except during fasting)
- Water (e.g. ad libitum): ad libitum access to filtered tap water
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-24
- Humidity (%): 40-54
- Air changes (per hr): no details
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 11 July 2000 To: 25 July 2000

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Individual doses were calculated based on initial body weight and were in the range of 0.28 to 0.38 mL. The specific gravity of the undiluted test substance was stated to be 1.028 g/mL

Doses:
Animals were gavaged with a single dose of 2000 mg/kg bw
No. of animals per sex per dose:
Five
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 1 and 3 hours post-dosing and at least once daily thereafter for 14 days. Body weights were recorded on Day 0 (shortly before dosing) and on Days 7 and 14 (termination)
- Necropsy of survivors performed: Yes, at study termination (Day 14)
- Other examinations performed: Clinical signs (mortality, signs of gross toxicity and behavioural changes), body weight
Statistics:
Not required.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality at the limit dose
Mortality:
There were no mortalities.
Clinical signs:
One rat appeared hypoactive at 1 hour post dosing. No other clinical signs were observed and all other rats appeared active and healthy during the observation period.
Body weight:
All rats gained weight throughout the observation period
Gross pathology:
No gross abnormalities were observed at terminal necropsy.
Other findings:
No other findings.

Any other information on results incl. tables

The acute oral LD50 of the test material was found to be greater than 2000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute oral LD50 was >2000 mg/kg bw.
Executive summary:

The acute oral toxicity of ST 30 C 00 (aurantiol pure) was evaluated in Sprague-Dawley rats, according to OECD Guideline 401. Five males and five female rats were administered the undiluted test substance by gavage, at a dose of 2000 mg/kg bw. The animals were observed for mortality, signs of reaction to treatment and behavioural changes at least once daily for 14 days. Bodyweights were recorded on the day of administration and again on Days 7 and 14. All rats were euthanised on Day 14 and gross necropsies were performed. All rats survived and all gained weight during the study. With the exception of one rat that appeared hypoactive 1 hour post-dosing, all animals appeared active and healthy during the study. No abnormalities were detected at necropsy. Under the conditions of the study, the acute oral LD50 of aurantiol pure was found to be > 2000 mg/kg bw.