Naphtha (petroleum), steam-cracked, hydrotreated, C9-10-arom.-rich

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant, guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1990

Report date:

1990

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.1175 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Naphtha (petroleum), steam-cracked middle arom.

EC Number:

271-138-9

EC Name:

Naphtha (petroleum), steam-cracked middle arom.

Cas Number:

68516-20-1

IUPAC Name:

Naphtha (petroleum), steam-cracked middle arom.

Constituent 2

Reference substance name:

E000144700

IUPAC Name:

E000144700

Details on test material:

- Name of test material (as cited in study report): E000144700
- Physical state: Clear, pale yellow to yellow liquid, gasoline-like naphtha odour
- Analytical purity: Not reported
- Lot/batch No.: Not reported
- Stability under test conditions: Stable
- Storage condition of test material: 50-80°F
- Test material data responsibility of study sponsor

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Sasco, Inc., Omaha, Nebraska, USA
- Sex: 5 males and 5 females
- Age at study initiation: Young adults (less than 12 weeks of age)
- Weight at study initiation: 190-350 g at pre-fast. Weights were within 20% of the group mean
- Housing: Individually in stainless steel, wire mesh bottom cages
- Diet: Agway Rodent Feed ad libitum, except overnight prior to dosing
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 64-79°F
- Humidity: 40-70%
- Air changes: At least 10/hr
- Photoperiod: 12hrs dark / 12hrs light

IN-LIFE DATES: From: 23 February 1990 To: 26 February 1990

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

- Undiluted test article was administered by oral gavage.
- Individual dosing volumes were adjusted based on the density of the test article and the animal's fasted bodyweight.

Doses:

5000 mg/kg to each animal

No. of animals per sex per dose:

5 per sex

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 4 days
- Frequency of observations and weighing: Observations were made hourly for the first 4 hours immediately after dosing and twice daily (a.m. and p.m.) for the next 4 days - a total of 5 days of observation.
- Necropsy of survivors performed: yes. Animals dying on test also underwent a post mortem examination.
- Other examinations performed: Animal body weights were recorded on arrival, the day before dosing (pre-fast), the day of dosing (fasted) and at animal death.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: 1/10 mortalities at 5000 mg/kg

Mortality:

0/5 males, 1/5 females (day 3)

Clinical signs:

other: All of the animals on study exhibited one or more of following: oral / nasal / ocular discharge, tremors, ataxia, abnormal stools, lethargy, moribund, stained coat, alopecia, hunched posture.

Gross pathology:

One animal had alopecia in abdominal area, one had staining in the nasal and perineal regions

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 for E000144700 is greater than 5000 mg/kg.

Executive summary:

The acute oral toxicity of E000144700 (CAS 68516 -20 -1) was determined in a group of 5 male and 5 female rats administered a single dose of undiluted test substance at a dose of 5000 mg/kg. One of the animals died and adverse clinical signs including oral / nasal / ocular discharge, tremors, ataxia, abnormal stools, lethargy, moribund, stained coat, alopecia, hunched posture were observed.

The acute oral LD50 is greater than 5000 mg/kg and no classification is warranted under GHS/CLP.