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Toxicological information

Acute Toxicity: oral

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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:
1984-05-02 to 1984-08-08
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study is classified as reliable with restrictions because it is an acceptable and well documented study report.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
other: low viscosity liquid hydrocarbon
Details on test material:
Substance as identified in the study report: API 83-07 (CAS# 64741-59-9)
Physical Description: light brown liquid
Initial Boiling Point (°F): 464
Final Boiling Point (°F): 701
Gravity API degrees: 14.1

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Charles River Laboratories, Inc., Wilmington, Massachusetts
- Age at study initiation: 7 weeks old
- Weight at study initiation: females weighed from 275 to 326 grams while males weighed 301 to 349 grams
- Fasting period before study: overnight prior to test material administration
- Housing: group cages; individually housed after dosing
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 to 24°C
- Humidity (%): 38 to 68%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hours light/12 hours dark


IN-LIFE DATES: From: 1984-05-02 To: 1984-08-08

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Dose volume varied based on the average bulk density of the test material (0.97 g/mL)
Doses:
Males: 3200, 5000 or 6250 mg/kg
Females: 2050, 3200, 5000, or 6250 mg/kg
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for clinical signs and mortality were taken at hourly intervals for the first 6 hours after test material administration and twice daily thereafter until study termination. Rats were weighed before fasting, just prior to test material administration, and 7 and 14 days after test material administration.
- Necropsy of survivors performed: yes; necropsy of all animals was performed
Statistics:
No data reported.

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
4 660 mg/kg bw
95% CL:
3 500 - 6 180
Sex:
female
Dose descriptor:
LD50
Effect level:
3 200 mg/kg bw
95% CL:
2 310 - 4 430
Mortality:
In males, 1 of 5, 3 of 5, and 4 of 5 animals died when administered test material at dose levels of 3200, 5000, and 6250 mg/kg, respectively.
In females, 0 of 5, 3 of 5, 4 of 5, and 5 of 5 animals died when administered test material at dose levels of 2050, 3200, 5000, and 6250 mg/kg, respectively.
Clinical signs:
Clinical signs included hypoactivity; diarrhoea; yellow or brown-stained anal, genital and abdominal areas; hair loss on abdomen; ataxia; red-stained nose and mouth; prostration; lacrimation; hypothermic to touch; and death.
Body weight:
No changes in body weight in reported.
Gross pathology:
No significant findings were reported.
Other findings:
None reported.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Oral LD50 values of 4660 mg/kg body weight (males) and 3200 mg/kg body weight (females) were reported. The test material is not classified according to EU criteria.
Executive summary:

The acute oral toxicity of light catalytically cracked distillate was evaluated in fasted male and female Sprague Dawley rats. The test substance was administered undiluted at dose levels of 2050, 3200, 5000, or 6250 mg/kg in females and 3200, 5000, or 6250 mg/kg in males. The animals were observed hourly for clinical signs and mortality for 6 hours after test material administration, then twice daily thereafter for 14 days. Body weights were recorded prior to, and at 7 and 14 days after, test material administration. All animals were sacrificed 14 days post-treatment and subjected to a gross necropsy.

Clinical signs included hypoactivity; diarrhoea; yellow or brown-stained anal, genital and abdominal areas; hair loss on abdomen; ataxia; red-stained nose and mouth; prostration; lacrimation; hypothermic to touch; and death. Mortality was observed in 1 of 5, 3 of 5, and 4 of 5 males at dose levels of 3200, 5000, and 6250 mg/kg, respectively. In females, mortality was observed in 0 of 5, 3 of 5, 4 of 5, and 5 of 5 animals at dose levels of 2050, 3200, 5000, and 6250 mg/kg, respectively. No abnormal necropsy findings were reported. An oral LD50 of 4660 mg/kg body weight (males, 95% C.I.: 3.5-6.18) and 3200 mg/kg body weight (females, 95% C.I.: 2.31-4.43) was reported by the study authors. The test material is not classified according to EU criteria.

This study received a Klimisch score of 2 and is classified as reliable with restrictions because it is an acceptable and well documented study report.