Asphalt, sulfonated, sodium salt

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1985-09-18 to 1985-10-16

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: EPA requirements, 40 CFR 158.135

Deviations:

no

Principles of method if other than guideline:

Method References: Acute oral toxicity study in rats-EPA Assessment Guidelines, Subdivision F: Hazard Evaluation: Human and Domestic Animals, Series 81-1 (November 1982) and Revised Acute Toxicity Testing Guidelines, Acute Exposure Oral Toxicity, October 1984. Good Laboratory Practice Standards, Federal Register, November 29, 1983.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Soltex product #2

IUPAC Name:

Soltex product #2

Constituent 2

Reference substance name:

Soltex contains 85% w/w Asphalt, sulfonated, sodium salt (CAS# 68201-32-1) (EC # 269-212-0)

IUPAC Name:

Soltex contains 85% w/w Asphalt, sulfonated, sodium salt (CAS# 68201-32-1) (EC # 269-212-0)

Details on test material:

- Name of test material (as cited in study report): Soltex Product #2
- Molecular formula (if other than submission substance): N/A
- Molecular weight (if other than submission substance): N/A
- Smiles notation (if other than submission substance): N/A
- InChl (if other than submission substance): N/A
- Structural formula attached as image file (if other than submission substance): N/A
- Substance type: active
- Physical state: dark brown granular material

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Kingston, NY
- Age at study initiation: young adult
- Weight at study initiation: Initial body weights of the males ranged from 252.4 to 299.0 g, and the initial body weights of the females ranged from 227.6 to 264.7 g
- Fasting period before study: Food was withheld overnight before test substance administration, but water was available.
- Housing: Animals were maintained individually in elevated wire-mesh cages.
- Diet (e.g. ad libitum): ad libitum except during fasting period
- Water (e.g. ad libitum): ad libitum
- Acclimation period: ~1 week


ENVIRONMENTAL CONDITIONS
- Temperature (deg. C): Animal quarters were temperature-controlled. No further information was provided.
- Humidity (%): Animal quarters were humidity-monitored. No further information was provided.
- Air changes (per hr): N/A
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 1985-10-02 To: 1985-10-16

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Polar Distilled Water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: N/A
- Amount of vehicle (if gavage): dosage factor was 20 mL/kg
- Justification for choice of vehicle: N/A
- Lot/batch no. (if required): 51267
- Purity: N/A


MAXIMUM DOSE VOLUME APPLIED: N/A


DOSAGE PREPARATION (if unusual):The required amount of test substance was weighed on an appropriate balance and placed into pre-calibrated glass beakers. Distilled water was added to each beaker to bring the mixture to the desired volume. The mixtures were stirred on a Tekmar Tissue Miser for approximately 2-3 minutes and then on a magnetic stirrer for approximately 3-4 minutes. All mixtures were stirred while dosing. The test substance was assumed to be 100 % pure for purposes of dosage calculations.


CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Dose level was selected based on a range-finding study.

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each animal was observed for signs of toxic and pharmacologic effects at 1, 2 and 4 hours after administration and once daily thereafter to 14 days. Mortality/moribundity was recorded twice daily. Individual body weights were recorded immediately prior to treatment, at 7 days and at termination.
- Necropsy of survivors performed: yes; observations were recorded.
- Other examinations performed: N/A

Statistics:

N/A

Results and discussion

Preliminary study:

Materials and Methods:
-One rat/sex was dosed at levels of 1000, 2000, 3000, 4000 and 5000 mg/kg bw (initial body weights of males ranged from 205.7 to 221.8 g, and the initial body weights of females ranged from 203.0 to 236.1 g).
-Each animal was observed for signs of toxic and pharmacologic effects at 1, 2, 4, 24 and 48 hours after administration. Mortality/moribundity was recorded twice daily. Individual body weights were recorded immediately prior to treatment and at termination. At termination, all rats were sacrificed and observations were recorded.
Results:
-No animals were found dead.
-Clinical signs were limited to instances of soft feces and/or a rough coat in all groups at one or more intervals. All animals gained weight from initiation to termination.
- Gross pathology findings noted were limited to pale adrenals in Groups 1-3 (1000 mg/kg, 2000 mg/kg, and 3000 mg/kg) and Group 5 (5000 mg/kg) males and in Group 2 (2000 mg/kg) and Groups 4-5 (4000 mg/kg and 5000 mg/kg) females, and dark adrenals were noted in the Group 4 (4000 mg/kg) males.

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks:

No animals died in the study.

Remarks on result:

other: equivalent to an LD50 of >4250 mg SAS/kg bw

Mortality:

No animals were found dead.

Clinical signs:

other: -Clinical signs noted consisted of soft feces in three males and all females at one hour post dose, in all animals at two and four hours, and a rough coat in all animals on Day 1. All animals appeared normal from Day 2 through termination.

Gross pathology:

No observable gross pathology was noted in any of the animals upon necropsy.

Other findings:

N/A

Any other information on results incl. tables

N/A

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based upon the results of this study, the LD50 was estimated to be greater than 5000 mg/kg of body weight in both female and male rats.

Executive summary:

N/A