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Toxicological information

Acute Toxicity: oral

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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other: GLP compliant, guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment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:
EPA OTS 798.1175 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
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 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:
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.
Body weight:
No effects.
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 Dir 67/548/EEC or under GHS/CLP.