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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Justification for type of information:
data is from peer-reviewed journal

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Acute Toxicity Evaluation of Solvent Red 1
Author:
Gunda Reddy and Dale A. Mayhew
Year:
1996
Bibliographic source:
International Journal of Toxicology Vol 15, Issue 1_suppl, pp. S43 - S44, 1996
Reference Type:
secondary source
Title:
Dermal, Eye and Oral toxicological evaluations, phase IV report with Disperse Red 11, Disperse Blue 3, Solvent Red 1 and Red and Violet Mixtures.
Author:
U.S. Army Medical Bioengineering Research and development Laboratory
Year:
1986
Bibliographic source:
NTRL- April - 1986, Page no 1-169.

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
Acute oral toxicity study of Solvent Red 1 in rat.
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Solvent Red 1
- Molecular formula (if other than submission substance): C17H14N2O2
- Molecular weight (if other than submission substance): 278.31 g/mole
- Substance type: Organic
- Physical state: Solid
Specific details on test material used for the study:
- Name of test material (as cited in study report): Solvent Red 1
- Molecular formula (if other than submission substance): C17H14N2O2
- Molecular weight (if other than submission substance): 278.31 g/mole
- Substance type: Organic
- Physical state: Solid

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals and environmental conditions:
Details on test animal
TEST ANIMALS
- Source: Charies river breeding laboratories, IC (postage NY, facility)
- Age at study initiation: No data available
- Weight at study initiation: 208-221 g male, 174-183 g female.
- Fasting period before study: Yes, fasted overnight.
- Housing: Animals were housed in the appropriate randomly selected cage. Each animal was then assigned a sequential animal number unique within American Biogenics Corporation (ABC) and identified with an ear tag bearing this animal number, The sequential animal number was listed on a cage card that was affixed to the front of the animal's cage. Rooms were cleaned daily and the cages were cleaned and sanitized as specified in ABC SOP's. Urine and feces fell through the wire mesh floor onto animal caging board. The cage boards were changed at least 2 to 3 times per week.
- Diet (e.g. ad libitum): Purina Certified Rodent Chow 5002, ad libitum, except for fasting prior to dosing.
- Water (e.g. ad libitum): Filtered tap water was provided through an automatic watering system and was analyzed periodically, ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 7 °C
- Humidity (%): 30-70 %
- Air changes (per hr): No data available
- Photoperiod (hrs dark / hrs light): 6:00 a.m. to 6:00 p.m. (12 hour light/dark, cycle)

IN-LIFE DATES:
From: October 30, 1985
To: November 13, 1985

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
corn oil
Details on oral exposure:
Details on exposure
VEHICLE
- Concentration in vehicle: 5000 mg/kg bw
- Amount of vehicle (if gavage): 28 mllkg
- Justification for choice of vehicle: com oil
- Lot/batch no. (if required): No data available
- Purity: No data available

MAXIMUM DOSE VOLUME APPLIED: No data available

DOSAGE PREPARATION (if unusual): Solvent Red 1 was suspended in 18 % weight/volume corn oil in two doses and then administered.

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: No data available

Doses:
5000 mg/kg bw

No. of animals per sex per dose:
Total:10
5 male , 5 female
Control animals:
not specified
Details on study design:
Details on study design
- Duration of observation period following administration: 14 days (or other?): 14 days

- Frequency of observations and weighing: on day 0 and daily thereafter.
- Necropsy of survivors performed: Yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: Yes, clinical signs, body weight and histopathology were performed.
Statistics:
The mean, standard deviation, and standard error were calculated for the body weight data and for the amount of test article administered.
For oral LD50 value, the 95 percent confidence interval, the slope of the dose-response curve, and correction factors for 0 and 100 percent observed responses were calculated by computer program employing the methodology of Litchfield and Wilcoxon.

Results and discussion

Preliminary study:
not specified
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: No mortality observed
Mortality:
No mortality was observed in treated rat at 5000 mg/kg bw
Clinical signs:
Red colored urine and stool; loose stool; red stained fur in the perianal region, on the head and ventral portion of the body, on the muzzle and red colored stain on the tail of treated rat
Body weight:
Overall body weight gain was observed in treated rat
Gross pathology:
No gross pathological abnormal findings were observed in treated rat.
Other findings:
Red colored urine and stool; loose stool was observed in treated rat.

Applicant's summary and conclusion

Interpretation of results:
Category 5 based on GHS criteria
Conclusions:
LD50 was considered to be > 5000 mg/kg bw when Fischer 344 male and female rats were treated Solvent Red 1 (manganese(2+) bis(phosphinate)) orally.
Executive summary:

In acute oral toxicity study, Fischer 344 male and female rats were treated Solvent Red 1 (manganese(2+) bis(phosphinate)) in the concentration of 5000 mg/kg bw in corn oil orally by gavage. No mortality was observed in treated rat at 5000 mg/kg bw. Red colored urine and stool; loose stool; red stained fur in the perianal region, on the head and ventral portion of the body, on the muzzle and red colored stain on the tail of treated rat. Overall body weight gain was observed in treated rat. No gross pathological abnormal findings were observed in treated rat. Therefore, LD50 was considered to be > 5000 mg/kg bw when Fischer 344 male and female rats were treated Solvent Red 1 (manganese(2+) bis(phosphinate)) orally.