Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Pre-GLP study following a method equivalent to a recognised guideline at a limit dose, with some deviations not expected to affect the reliability of the study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Limit dose of 5000mg/kg bw applied single dose; all male rat species, no gross pathology completed.
Principles of method if other than guideline:
The principles of the method were in accordance with the US 16 CFR 1500.3 definitions.
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Physical state: liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Recognised animal supplier
- Age at study initiation: 8 weeks
- Weight at study initiation: 208 - 232 g
- Fasting period before study: not reported
- Housing: The animals were housed 5/cage in suspended wire mesh cages· (20" x 10" x 7").
- Diet: rat chow ad libitum
- Water: ad libitum
- Acclimation period: at least one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 21
- Humidity (%): not reported
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): not reported

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
The test material was given orally by syringe and 13 gauge blunt end needle. One group of ten male rats were: dosed at 5000 mg/kg of body weight. For liquid materials, the dose was based on the sample weight as calculated from the specific gravity.
Doses:
5000 mg/kg
No. of animals per sex per dose:
10 males
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The rats were observed 3-4 hours after dosing and once daily for 14 days.
- Necropsy of survivors performed: no

Results and discussion

Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
One animal died on day 1.
Clinical signs:
Lethargy, ataxia and ptosis were noted in five or more animals 3-4 hours post dose. Isolated instances of prostration and negative righting reflex were noted 3-4 hours post dose. Lethargy, ptosis, piloerection and chromorhinorrhea were noted in five or more animals on Days 1 and 2 and periodically through to Day 5. All surviving animals were normal on Day 6. Isolated instances of lethargy, ptosis, and chromorhinorrhea were sporadically noted on Days 7 through to 14.
Body weight:
No data
Gross pathology:
Not examined

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: US CPSC / US FDA
Conclusions:
Under the conditions of this study the LD50 was determined to be > 5000 mg/kg in male wistar rats.
Executive summary:

The pre-GLP study was performed following a method similar to OECD 401 to assess the acute oral toxicity potential of the test substance to male Wistar rats. The test material was administered as a single oral dose to a group of 10 male rats orally, at a dose level of 5000 mg/kg bodyweight. All animals were observed for a fourteen day period for any signs of toxicity or other effects of treatment. Animals were not examined for gross pathology. One animal died on Day 1 at this dose level. Lethargy, ataxia and ptosis were noted in five or more animals 3-4 hours post dose. Isolated instances of prostration and negative righting reflex were noted 3-4 hours post dose. Lethargy, ptosis, piloerection and chromorhinorrhea were noted in five or more animals on Days 1 and 2 and periodically through to Day 5. All surviving animals were normal on Day 6. Isolated instances of lethargy, ptosis, and chromorhinorrhea were sporadically noted on Days 7 through to 14. Under the conditions of this study the LD50 was determined to be >5000 mg/kg.