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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
No information.
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Study is old data conducted to no recognised test guideline. The data are reported in a brief resume of the test and observations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Test substance was administered orally as supplied by the sponsor to 5 male and 5 female rats. The method of dosing is not reported.

GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Samples : Colorless viscous liquid.
Markings : Krontrex 50
Lot No. 7-107.
No other information on the test material is detailed within the report.

Test animals

Species:
rat
Strain:
not specified
Sex:
male/female
Details on test animals and environmental conditions:
Not reported.

Administration / exposure

Route of administration:
other: no data.
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Single dose of 5000 mg/kg administered as received. No other data included.
Doses:
5000 mg/kg
No. of animals per sex per dose:
5 animals per sex per dose
Control animals:
no
Details on study design:
No data.
Statistics:
No data.

Results and discussion

Preliminary study:
No data.
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
95% CL:
>= 7 - <= 46
Mortality:
One animal on Day 1 and two animals on Day 2 died
Clinical signs:
No data.
Body weight:
Average bodyweight gain for male animals was 44g and the average bodyweight gain for female animals was 29g.
Gross pathology:
No data.
Other findings:
None

Any other information on results incl. tables

Mortality data

Dose level mg/kg

No. rats dosed

deaths per day

Mortality after 14 days

1

2

3

4

5

6

7

8

9

10

11

12

13

14

5000

10

1

2

0

0

0

0

0

0

0

0

0

0

0

0

3/10

Individual bodyweight data

Dose Level mg/kg

Animal No. & sex

Body weights (g)

Initial

14 Days

5000

021M

275

280

 

022M

264

320

 

023M

357

397

 

024M

273

---

 

025M

268

325

 

Average

287

311

5000

026F

186

215

 

027F

180

---

 

028F

210

235

 

029F

205

---

 

030F

190

220

 

Average

194

223

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The substance demonstrated a 30% mortality rate and has been completed as a limit test at 5000 mg/kg The LD50 is considered to be >5000 mg/kg.

Executive summary:

The test sample was dosed orally to 5 male and 5 female rats at a dose of 5000 mg/kg. Assessed over a 14 day period, 1 male and 2 female deaths occured and the study was completed as a limit test. The LD50 is considered >5000 mg/kg.

No classification is applicable on the basis of the results.