Stoddard solvent

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Single dose

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:

Published data in readily available literature.Reliability score 2 on the basis of the weight of evidence found during review of public documents existing relating to toxicological data

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

10 rats male/female test substance was administered to 10 rats male/female in undiluted form MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw

GLP compliance:

yes

Test type:

acute toxic class method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Stoddard solvent

EC Number:

232-489-3

EC Name:

Stoddard solvent

Cas Number:

8052-41-3

Molecular formula:

C10H22

IUPAC Name:

stoddard solvent

Test material form:

liquid

Specific details on test material used for the study:

C9-C13 Mixed aliphatics and aromatics (8052-41-3)

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: Bantin & Kingman, Fremont, CA- Age at study initiation: young adults (eight to twelve weeks old)
- Weight at study initiation: approximately 200 to 350 grams pre-fasting- Fasting period before study: animals were not fed the night before dosing
- Housing: individually housed in stainless steel, wire mesh bottom cages
- Diet: fresh certified Agway rodent feed provided ad libitum, feed was withheld the night before dosing
- Water: fresh potable water was provided ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS- Temperature (°C): 17 to 26 degrees Celsius, within protocol limits
- Humidity (%): 40 to 70%, within protocol limits
- Air changes (per hr): no less than ten air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No vehicle, test substance was administered in undiluted form MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 male and 5 female

Control animals:

yes

Details on study design:

- Duration of observation period following administration: fourteen days
- Frequency of observations and weighing: animals were observed hourly for first four hours after dosing and twice daily for the following fourteen days; animals were weighed when acquired by the testing facility, prior to fasting, prior to test administration, and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, external evaluation at necropsy

Statistics:

The mean and standard deviation for body weight data were calculated

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: Based on lack of mortality and systemic effects

Mortality:

No animals died during the testing period

Clinical signs:

other: All of the study animals exhibited one or more of the following clinical signs: nasal discharge, ocular discharge, abnormal stools, lethargy, stained coat, and alopecia.

Gross pathology:

At necropsy, one of the ten animals exhibited visual lesions, the remaining nine showed signs of alopecia in the inguinal and/or perineal regions.

Applicant's summary and conclusion

Interpretation of results:

other: not classified

Conclusions:

The LD50 value of >5000 mg/kg for Stoddard Solvent was determined in a rat study.
In an acute oral toxicity study, groups of fasted, young adult, Sprague Dawley rats, five male and five female, were given a single oral dose of undiluted Stoddard solvent at a dose of 5000 mg/kg bw and observed for 14 days.
There were no treatment related mortalities. All of the study animals exhibited one or more of the following clinical signs: nasal discharge, ocular discharge, abnormal stools, lethargy, stained coat, and alopecia. All animals gained weight during study period. At necropsy, one of the ten animals exhibited visual lesions, the remaining nine showed signs of alopecia in the inguinal and/or perineal regions. The oral LD50 was determined to be greater than 5000 mg/kg in males and females

Executive summary:

The LD50 value of >5000 mg/kg was determined in a rat study. In an acute oral toxicity study, groups of fasted, young adult, Sprague Dawley rats, five male and five female, were given a single oral dose of undiluted Stoddard solvent at a dose of 5000 mg/kg bw and observed for 14 days. There were no treatment related mortalities. All of the study animals exhibited one or more of the following clinical signs: nasal discharge, ocular discharge, abnormal stools, lethargy, stained coat, and alopecia. All animals gained weight during study period. At necropsy, one of the ten animals exhibited visual lesions, the remaining nine showed signs of alopecia in the inguinal and/or perineal regions. The oral LD50 was determined to be greater than 5000 mg/kg in males and females