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other: GLP compliant, guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment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

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Sasco, Inc., Omaha, Nebraska, USA.
- Age at study initiation: Young adults (< 12 weeks)
- Weight at study initiation: 190-350 g (pre-fast)
- Fasting period before study: overnight
- Housing: Individually in stainless steel, wire mesh bottom cages
- Diet: Agway Rodent Feed ad libitum (except during overnight pre-dose fast)
- Water: Fresh potable water ad libitum
- Acclimation period: 7 days

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

IN-LIFE DATES: From: 23 February 1990 To: 9 March 1990

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
DOSE VOLUME: 5 mL/kg. Individual dose volumes were adjusted based on the density (0.9145 g/mL) and the animals bodyweight.
Doses:
5000 mg/kg
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations hourly for initial 4 hours after dosing, twice daily thereafter. Bodyweights recorded pre-fast, pre-dose, week 1 and at termination.
- Necropsy of survivors performed: yes

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 and no significant macroscopic findings at only dose tested
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.