Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
1985-08-20 to 1986-02-06
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 or similar to guideline study OECD TG 401.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: oily liquid
Details on test material:
- Name of test material (as cited in study report): Light Paraffinic Distillate
- Test substance: Unrefined light paraffinic distillate
- Molecular weight (if other than submission substance): 296
- Physical state: Liquid (light amber)
- CAS number: 64741-50-0
- Viscosity, cSt: 2.67 at 100°C
- API Gravity: 31.5
- Flash Point: (°F) 372
- Sulfur, Wt %: 0.2
- Nitrogen ppm: 256
- Distillation ASTM D 86 equivalent (°F) range: 601-803 (10-95%)
- Initial Boiling Point (°F): 579
- Composition of test material, Wt. %:
Olefins: 39.7
Naphthenes 21.7
- PONA % by MS: 37

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: Approximately 7 weeks
- Weight at study initiation: Males: 304 to 350 grams; females: 222 to 250 grams
- Fasting period before study: Overnight (water was not withheld)
- Housing: Individually housed
- Diet (e.g. ad libitum): Ad libitum; Purina Certified Rodent Chow #5002
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 to 23
- Humidity (%): 52 to 66
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 5.81 mL/kg of body weight

CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Based upon the average bulk density of 0.86 g/mL
Doses:
Single dosage level: 5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed hourly for the first 6 hours, twice daily thereafter for 14 days. Body weights were taken before fasting, prior to test material administration, and at 7 and 14 days.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, and histopathology
Statistics:
No data reported.

Results and discussion

Preliminary study:
Dose volume of test material was based upon the average bulk density of 0.86 g/mL.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
Number Dead/Number Dosed:
male - 0/5
female - 0/5
Clinical signs:
Clinical signs observed during study included: hypoactivity, diarrhoea, and yellow-stained anal area.
Body weight:
Male: average (g)
pre-fast: 329
initial: 306
day 7: 349
terminal: 379

Female: average (g)
pre-fast: 238
initial: 226
day 7: 251
terminal: 269
Gross pathology:
No visible lesions on any of the animals.

Any other information on results incl. tables

Acute Oral Toxicity

Summary of Clinical Signs

(Number of Animals Affected)

 

 

Hours

Days

Observation

1

2

3

4

5

6

1

2

3

4

5

6

7

8

9

10

11

12

13

14

5.0 g/kg - Males

Appeared normal

5

2

2

1

1

0

0

0

0

5

5

5

5

5

5

5

5

5

5

5

Diarrhoea

0

3

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Yellow-stained anal area

0

3

3

4

4

5

5

1

0

0

0

0

0

0

0

0

0

0

0

0

Hypoactivity

0

0

0

0

0

0

0

5

5

0

0

0

0

0

0

0

0

0

0

0

 

5.0 g/kg – Females

Appeared normal

5

2

2

0

0

0

0

0

4

5

5

5

5

5

5

5

5

5

5

5

Yellow-stained anal area

0

3

3

5

5

5

5

5

1

0

0

0

0

0

0

0

0

0

0

0

Hypoactivity

0

0

0

0

0

0

0

3

1

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Not considered toxic Criteria used for interpretation of results: EU
Conclusions:
With an estimated Oral LD50 of >5000mg/kg of body weight, the test material is considered practically nontoxic.
Executive summary:

In an acute oral toxicity study, groups of fasted, 7 week old Sprague-Dawley albino rats (5 male/5 female) were given a single oral dose of light paraffinic distillate at a dose of 5000 mg/kg bw and observed for 14 days. 

 

Clinical signs observed during the study included: hypoactivity, diarrhoea, and yellow-stained anal area. All animals had returned to normal by study day 4. There were no mortalities during this study. Necropsy pathology discovered no visible lesions on any of the animals.  The oral LD50 was determined to be greater than 5000 mg/kg of body weight in both males and females.

This study received a Klimisch score of 1 and is classified as reliable without restrictions because it was conducted according to or similar to guideline study OECD TG 401.