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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:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Datais from National Toxicology Program

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1987

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Acute oral toxicity study of C.I. Acid Orange 10 in rats
GLP compliance:
not specified
Test type:
other: No data
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):C.I. Acid Orange 10 - Molecular formula (if other than submission substance):C16H10N207S2.2Na - Molecular weight (if other than submission substance):452.37 g/mole - Substance type:Organic - Physical state:No data available Purity80% pure - Impurities (identity and concentrations):20 %

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: NCI Frederick Cancer Research Center, Frederick, Maryland- Age at study initiation: Male: 6 weeks old, Female: 5 weeks old - Weight at study initiation: No data available - Fasting period before study: No data available - Housing: Animals were housed five per cage in solid-bottom polycarbonate cages (LabProducts, Inc., Garfield, NJ) equipped withDuPont 2024 spun-bonded polyester filters and supplied with Absorb-Dri hardware chips (Lab Products, Inc.). Cages and bedding were changed twice weekly. - Diet (e.g. ad libitum): Ralston Purina Laboratory Chow Meal, ad libitum, Feed hoppers were changed once per week.- Water (e.g. ad libitum): Tap water, supplied by an automatic watering system (Edstrom Industries, Waterford, WI), ad libitum- Acclimation period: 2 weeks ENVIRONMENTAL CONDITIONS- Temperature (°C): 21° and 23° C- Humidity (%): 40%-60% - Air changes (per hr): Incoming air was passed through a filter equipped with an electrostatic precipitator at a volume equivalent to 15 changes per hour.- Photoperiod (hrs dark / hrs light): Fluorescent lighting was provided 12 hours per day.IN-LIFE DATES: From: To: No data available

Administration / exposure

Route of administration:
oral: feed
Vehicle:
other: Ralston Purina Laboratory Chow Meal
Details on oral exposure:
VEHICLE- Concentration in vehicle: 600, 1250, 2500, 5000, 10000 and 20000 mg/kg bw- Amount of vehicle (if gavage): No data available - Justification for choice of vehicle: No data available - Lot/batch no. (if required): No data available - Purity: No data available MAXIMUM DOSE VOLUME APPLIED: No data available DOSAGE PREPARATION (if unusual): C.1. Acid Orange 10 was mix with weighed amounts of Purina Laboratory Chow animal meal in a Patterson Kelly twin shell blender for 15 minutes. Formulated diets were stored at 23° C for no longer than 10 days.CLASS METHOD (if applicable)- Rationale for the selection of the starting dose: No data available
Doses:
600, 1250, 2500, 5000, 10000 and 20000 mg/kg bw
No. of animals per sex per dose:
Total: 60600 mg/kg bw: 5 male , 5 female 1250 mg/kg bw: 5 male , 5 female2500 mg/kg bw: 5 male , 5 female5000 mg/kg bw: 5 male , 5 female10000 mg/kg bw: 5 male , 5 female20000 mg/kg bw: 5 male , 5 female
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days - Frequency of observations and weighing: No data available - Necropsy of survivors performed: yes- Other examinations performed: survival and clinical sign were observed.
Statistics:
No data available

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 20 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No effect on survival, clinical sign and gross pathology
Mortality:
No effect on survival of treated male and female rats was observed.
Clinical signs:
No clinical sign were observed in treated male and female rats.
Body weight:
No data available
Gross pathology:
No gross pathological changes were observed in treated male and female rats.
Other findings:
No data available

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
LD50 was considered to be >20000 mg/kg bw when F344/N male and female rats were treated with C.I. ACID ORANGE 10 orally in feed for 24 hours.
Executive summary:

In a acute oral toxicity study,F344/N male and female rats were treated with C.I. ACID ORANGE 10 in the concentration of600, 1250, 2500, 5000, 10000 and 20000 mg/kg bw orally in feed and observed for 14 days. No effect on survival and clinical sign were observed in treated male and female rats. In addition, No gross pathological changes were observed in 20000 mg/kg bw treated male and female rats. Therefore,  LD50 was considered to be>20000 mg/kg bw when F344/N male and female rats were treated with C.I. ACID ORANGE 10 orally in feed for 24 hours.