Extracts (petroleum), heavy naphthenic distillate solvent

Acute Toxicity: oral

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

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restriction because it was conducted similar to OECD Test Guideline 401.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

64742-05-8

IUPAC Name:

64742-05-8

Constituent 2

Reference substance name:

Light paraffinic distillate solvent extract

IUPAC Name:

Light paraffinic distillate solvent extract

Test material form:

liquid: viscous

Details on test material:

- Name of test material (as cited in study report): API 83-16
- Physical state: Liquid, brown
- Viscosity, SSU: 67.2 at 100°F
- API Gravity: 16.7
- Flash Point: (°F) 335
- Pour Point (°F): 20
- Aniline Point (°F): 95.5
- Sulfur, Wt %: 2.64

- Composition of test material ASTM D-2007, Wt. %:
Saturates: 29.2
Aromatics 68.6

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 Laboratories, Inc., Stone Ridge, NY
- Age at study initiation: 7 weeks old
- Weight at study initiation: 316 to 346 g (males), 234 to249 g (females)
- Fasting period before study: Overnight before dosing
- Housing: Group cages
- Diet (e.g. ad libitum): Purina certified rodent chow 5002, ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: At least 14 days

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

IN-LIFE DATES: From: 03-12-1984 To: 17-12-1984

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5.43 mL/kg body weight based upon average bulk density of 0.92 g/mL = 5000 mg/kg body weight

Doses:

5000 mg/kg body weight

No. of animals per sex per dose:

5 per sex

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed for clinical signs and mortality at hourly intervals during the first 6 hours after test material administration and twice daily thereafter for 14 days
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, mortality

Statistics:

No data reported.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

0/10

Clinical signs:

other: Clinical signs of toxicity observed included hypoactivity, ataxia, red stained face, yellow-stained anal area, diarrhoea, and oily haircoat. All animals had returned to normal within 8 days of test material administration.

Gross pathology:

No visible lesions

Other findings:

Initial: 314g (male), 231g (female)
Day 7: 343g (male), 246g (female)
Terminal: 386g (male), 267g (female)

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information LD50 >5000 mg/kg bw Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study, the oral LD50 for male and female rats administered light paraffinic distillate solvent extract was greater than 5000 mg/kg body weight. According to EU criteria, the test material is not classified.

Executive summary:

In an acute oral toxicity study, groups of fasted, 7 week old Sprague-Dawley rats (5/sex) were given a single oral dose of undiluted light paraffinic distillate solvent at a dose of 5000 mg/kg body weight. Animals were observed for 14 days.

 

Clinical signs observed included: hypoactivity, ataxia, red stained face, yellow-stained anal area, diarrhoea, and oily haircoat. All animals had returned to normal within 8 days of test material administration. The oral LD50 was determined to be greater than 5000 mg/kg body weight in males and females.

 

This study received a Klimisch score of 1 and is classified as reliable without restriction because it was conducted similar to OECD Test Guideline 401.