Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: oral

Currently viewing:

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

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

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.