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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:
1980-10-31 to 1980-11-14
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable without restriction because it was conducted according to OECD Guideline 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report Date:
1982

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): API 78-9 Solvent dewaxed light paraffinic oil
- CAS number: 64742-56-9
- API Identification number: API 78-9
- Molecular weight (if other than submission substance): 322
- Substance type: Other Lubricant Base Oil (Sufficiently Refined, IP 346 < 3%)
- Physical state: Liquid
- Analytical purity: Not reported
- Composition of test material, percentage of components: Saturates (88.7%); Aromatics (11.3%)
- Stability under test conditions: Not reported
- Storage condition of test material: Stable at room temperature
- Other:
Specific gravity 60/60: 0.8490
Viscosity: 64.2 SUS @ 100°F

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Taconi Farms, Germantown, New York
- Age at study initiation: Not reported
- Weight at study initiation: 200-300 grams
- Fasting period before study: 16 hours
- Housing: Individual in standard wire-bottom cages
- Diet (e.g. ad libitum): Purina Laboratory Chow (ad libitum)
- Water (e.g. ad libitum): Fresh water (ad libitum)
- Acclimation period: 1 week


ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported


IN-LIFE DATES: From: 1980-10-02 To: 1980-11-14

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
- Amount of vehicle (if gavage): TS administered without vehicle

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg (5 g/kg)
Doses:
5000 mg/kg (5 g/kg)
No. of animals per sex per dose:
5/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Twice daily for clinical signs; body weight on days 0, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Not performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Mortality:
None observed
Clinical signs:
No clinical signs of toxicity observed in either male or female rats
Body weight:
Body weight gain was normal in all animals through the post-exposure 14 day observation period.
Gross pathology:
Hydronephrosis of the right kidney was observed in one rat but was not considered treatment-related by the study authors. No other abnormalities were observed in any male or female rats.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
API 78-9 administered orally via gavage to young adult Sprague-Dawley rats has an acute oral LD50 >5,000 mg/kg body weight.
Executive summary:

In an acute oral toxicity study, paraffinic oil sample API 78-9 (CAS No. 64742-56-9) was administered via oral gavage to 5 Sprague-Dawley rats per sex at a single dose of 5,000 mg/kg (5 g/kg).

The rats were observed for clinical signs of toxicity, changes in body weight, and other gross abnormalities over a 14-day post-exposure observation period. All rats were killed and necropsied on day 14.

No mortalities or any sign of clinical sign of toxicity were observed in either male or female rats dosed at 5,000 mg/kg. Body weight gain was observed to be normal in all animals. One animal did exhibit hydronephrosis in the right kidney but this was not considered to be treatment-related. Necroscopy did not reveal any gross abnormalities in either male or female rats.

Acute oral LD50 >5,000 mg/kg (5 g/kg).

This study is classified as reliable without restriction because it was conducted according to OECD Guideline 401.