Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP, guideline-comparable proprietary study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Qualifier:
according to
Guideline:
other: Code of Federal Regulations (Part 191.1)
GLP compliance:
no
Remarks:
: study pre-dates GLP
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test material is described as a light yellow powder.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
Sprague-Dawley albino rats of weight 160-205 g were used in this test. The animals were fasted for 24 hours prior to treatment.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: Aqueous tragacanth
Details on oral exposure:
The test material was administered in single doses by means of a stomach tube.
Doses:
215, 464, 1000 and 2150 mg/kg bw
No. of animals per sex per dose:
5 male rats (body weight 160-205g) were used for each dose level
Control animals:
no
Details on study design:
The test material was administered in single doses by means of a stomach tube. Five animals were used for each dose level. The animals were fasted for 24 hours prior to treatment. The animals were observed for 14 days after treatment for mortalities and signs of toxicity.

Results and discussion

Preliminary study:
No preliminary study
Effect levels
Sex:
male
Dose descriptor:
LD50
Effect level:
791 mg/kg bw
95% CL:
467 - 1 350
Mortality:
At a dose level of 2150 mg/kg, all rats were found dead 6 hours after dosing. At a dose level of 464 and 1000 mg/kg, the rats that did died did so within 48 hours. For the dose levels, 464 mg/kg and 1000 mg/kg there was 2 out of 5 rats which resulted in death.
Clinical signs:
At all dose levels the rats became slightly depressed and irritable.
Body weight:
Body weight was not obtained after exposure.
Gross pathology:
No autopsies performed.
Other findings:
No further findings.

Any other information on results incl. tables

Mortality in the rat

Dose level (mg/kg bw)

215

464

1000

2150

0/5

2/5

2/5

5/5

 - 0 -48h   0 -48h  0 -6h

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 was calculated to be 791 (467 -1350) bw. The test substance is therefore classified as (R22) 'Harmful if swallowed' on the basis of this study.
Executive summary:

The acute oral toxicity of the substance was investigated in fasted male rats. Five male rats were gavaged with a single dose of the test material (in aqueous gum tragacanth) at dose levels of 215, 464, 1000 and 2150 mg/kg bw and observed for 14 days.

At the 2150 mg/kg bw, dose level all rats were found dead within six hours of dosing. At all levels, the test substance caused the rats to become depressed and irritable. At 464 and 1000 mg/kg bw, 2 out of 5 rats died. The acute oral LD50 was calculated to be 791 (467 -1350) mg/kg bw.