Registration Dossier

Toxicological information

Acute Toxicity: oral

Currently viewing:

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
Animals were not necropsied
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 200 - 300 g
- Fasting period before study: food was withheld for 12 to 24 hours prior to dose administration
- Housing: wire mesh cages with raised floors
- Diet: commercial rat food diet
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Animals were maintained in a conditioned animal room

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
The dosage to be applied was calculated based on the animal's weight. The test material was administered to the animals using a 16 gauge "ball point" needle and syringe.
Doses:
5, 10 and 15 mL/kg
No. of animals per sex per dose:
5 males and 5 females
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: animals were observed immediately following dose administration, after 1 hour, 4 hours and daily thereafter
- Frequency of weighing: animals were weighed at study initiation and again at study termination
- Necropsy of survivors performed: no
- Examinations performed: animals were observed for gross toxicological effects

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 15 mL/kg bw
Based on:
test mat.
Mortality:
None of the animals died during the study.
Clinical signs:
No clinical signs were reported.
Body weight:
All animals gained weight during the study.
Gross pathology:
Not applicable.
Other findings:
None reported.

Any other information on results incl. tables

Table 1: Results

Sex

No. of animals

Initial weight (average in g)

Dosage (mL/kg)

14 day mortality ratio

Final weight (average in g)

F

5

211

5

0/5

248

M

5

240

5

0/5

303

F

5

224

10

0/5

270

M

5

219

10

0/5

323

F

5

237

15

0/5

259

M

5

259

15

0/5

313

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the study, the acute oral LD50 of the test material was determined to be in excess of 15 mL/kg. The study is considered to be reliable, relevant and adequate for risk assessment and classification and labelling purposes.
Executive summary:

The acute oral toxicity of the test material was determined following a method similar to that outlined in the standardised guideline OECD 401. During the study, 5 Sprague Dawley rats of each sex were administered test material, by gavage, at dosage levels of 5, 10 and 15 mL/kg bw. Following dosing, animals were observed for a period of 14 days for signs of gross toxicological effects.

Under the conditions of the study, none of the animals died, no gross effects were noted and all animals gained weight. The acute oral LD50 of the test material was subsequently determined to be in excess of 15 mL/kg bw.