Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From June 14 to June 28, 1984
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study comparable to OECD test guideline No. 401 but GLP status not reported.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
other: Section 1500.3 - Federal Hazardous Substances Act Regulations - 16 CFR
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
not applicable
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Physical state: no data
- Sample received: 1984-06-04
- Storage condition of test material: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals, Inc., Boyertown, PA.
- Age at study initiation: no data
- Weight at study initiation: 200-300 g
- Fasting period before study: overnight deprivation of food
- Housing: 5 rats/cage by sex, in stainless steel cages with elevated wire mesh flooring
- Diet (e.g. ad libitum): Wayne Lab-Blox ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: appropriate time

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-23
- Humidity (%): 45-55
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
None
Doses:
5000 mg/kg bw
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: frequently on the day of dosage, and twice per day thereafter.
- Frequency of weighing: on the day of dosage (individually), and on Day 7 and 14 after dosing (grouped)
- Necropsy of survivors performed: yes, gross examinations
Statistics:
none

Results and discussion

Preliminary study:
not applicable
Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality
Clinical signs:
All animals appeared normal throughout the 14 day observation period
Body weight:
All animals gained weight
Gross pathology:
No gross abnormalities
Other findings:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Oral LD50Combined > 5000 mg/kg bw
Executive summary:

In a limit acute oral toxicity study performed similarly to the OECD test guideline No. 401, a group of fasted, Sprague-Dawley rats (5/sex) was administered a single oral dose of undiluted test material at 5000 mg/kg bw by gavage. The animals were observed for mortality, clinical signs and body weight for 14 days and then necropsied for macroscopic observations.

No mortality and no clinical signs were observed throughout the study. There was no adverse effect on bodyweight gain. No gross abnormalities were observed at necropsy.

 

Oral LD50Combined > 5000 mg/kg bw

 

Under the test conditions, the test material is not classified according to the annex VI of the Regulation EC No. 1272/2008 (CLP).

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.