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Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1980-10-31 to 1980-11-14
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 420.
Reason / purpose for cross-reference:
reference to same study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guidelineopen allclose all
according to guideline
OECD Guideline 401 (Acute Oral Toxicity)
equivalent or similar to guideline
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
GLP compliance:
Test type:
fixed dose procedure
Limit test:

Test material

Constituent 1
Reference substance name:
Solvent Dewaxed Light Paraffinic Oil (CAS # 64742-56-9) (For Petrolatum (Non-carcinogenic Feed-stock))
Solvent Dewaxed Light Paraffinic Oil (CAS # 64742-56-9) (For Petrolatum (Non-carcinogenic Feed-stock))
Details on test material:
Read across to Other Lubricant Base Oils (IP 346 < 3 wt%)
- Name of test material (as cited in study report): API 78-9 Solvent dewaxed light paraffinic oil
- Molecular weight (if other than submission substance): 322
- Substance type: Lubricant Base Oil (Sufficiently Refined, IP 346 < 3 wt%)
- 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

Details on test animals or test system and environmental conditions:
- 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

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

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg (5 g/kg)
5000 mg/kg (5 g/kg)
No. of animals per sex per dose:
Control animals:
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
Not performed

Results and discussion

Effect levels
Dose descriptor:
Effect level:
> 5 000 mg/kg bw
None observed
Clinical signs:
other: No clinical signs of toxicity observed in either male or female rats
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
Migrated information Criteria used for interpretation of results: EU
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:

Read across justification

No acute oral toxicity studies have been reported for petrolatum (non-carcinogenic feed-stock), but data have been reported for other lubricant base oils, materials similar to the oil entrained in petrolatum (non-carcinogenic feed-stock).

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)

Paraffinic oil 78-9 is practically non-toxic when administered orally via gavage to Sprague-Dawley rats.

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