Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Initiation date:October 14, 1980; Termination date: Octerber 27 1980
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): EHS-152
- Physical state: Clear, colourless liquid:
- Lot/batch No.: B-0228 (8-18-80)
- Storage condition of test material: Room temperature in a locked test compound cabinet

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan Industries, Inc., Indianapolis, Indiana
- Age at study initiation: Young adult
- Weight at study initiation: 213 to 287 grams
- Fasting period before study: Yes
- Housing: The animals individually housed in wire-bottomed cages.
- Acclimation period: The rats were quarantined and acclimated to laboratory conditions for 21 days prior to initiation of the study. Animals were examined twice during the quarantine period.

ENVIRONMENTAL CONDITIONS
Room conditionsm as well as availability of adequate food and water were checked and any noteworthy conditions recorded.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
VEHICLE
No vehicle used.

MAXIMUM DOSE VOLUME APPLIED: 4.9 ml/kg

DOSAGE PREPARATION (if unusual): Individual dose amounts were calculated using fasted bodyweights (day 0, mean: males 261 g, females 210 g) taken prior to dosing. The test material was measured in a plastic disposable syringe and administered directly into the rats stomach as a single dose using a rubber catheter and tubing adapter.
Doses:
One dose leve of 5 g/kg (5000 mg/kg)
No. of animals per sex per dose:
5 males and 5 females at 5000 mg/kg.
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of observations and weighing: All animals were observed closely for gross signs of systemic toxicity and mortality at frequent intervals during the day of dosing and at least twice daily thereafter for a total of 14 days. All animals were weighed on days -1, 0, 6 and 13.

- Necropsy of survivors performed: yes, all surviving animals were sacrificed by carbon dioxide asphyxiation and a gross necropsy performed on the visceral and thoracic cavities.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred among the test animals.
Clinical signs:
Findings recorded during the 14 day observation period were:

Three to Four and One-Half Hours after Dosing:
Slightly lethargic and ataxic (one male and one female at 4.5 hours)
Slightly loose feaces (one female)

Days 1 through 13:
Slightly ataxic (1 male at day 4 and one males at days 3 and 4)

Body weight:
Mean bodyweight gains appeared to be normal.
Gross pathology:
Examination of the thoracic and visceral cavities of animals at necropsy revealed no significant findings.

Any other information on results incl. tables

As no mortality occcurred among the test animals the LD50 could not be determined and is therefore considered as greater than 5000 mg/kg bodyweight.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
As no mortality occcurred among the test animals the LD50 could not be determined and is therefore considered as greater than 5000 mg/kg bodyweight.
Executive summary:

When the test substance was administered orally at one dose level (5000 mg/kg) to one group containing ten rats (5 males and 5 females), no deaths occurred and systemic signs noted were slight ataxia and lethargy (days 0, 3 and 4) in 3 animals and slightly loose faeces (day 0) in one animal.

As no mortality occcurred among the test animals the LD50 could not be determined and is therefore considered as greater than 5000 mg/kg bodyweight.