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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:
key study
Study period:
August form 9th to 28th, 2006
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 17 December 2001
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
female
Details on test animals and environmental conditions:
Females were fasted.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
water
Remarks:
distilled
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Two groups of three female: three female were treated, followed by a further group of three females at the same dose level.
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of clinical and mortality observations: monitored during the study.
- Necropsy of survivors performed: all animals were subjected to gross necropsy.

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths recorded.
Clinical signs:
No signs of systemic toxicity were observed.
Gross pathology:
Kidneys of all the females appeared stained green; in one case dark liver was observed.

Any other information on results incl. tables

Individual Clinical observations and mortality data

Animal number Effects noted
Hours after dosing Days after dosing
½ 1 2 4 1* 2* 3* 4 5 6 7 8 9 10 11 12 13 14
1 - 0 0 0 0 0 U 0 F U 0 F U 0 F U 0 0 0 0 0 0 0 0 0 0 0
1 - 1 0 0 0 0 U 0 F U 0 F U 0 F U 0 0 0 0 0 0 0 0 0 0 0
1 - 2 0 0 0 0 U 0 F U 0 F U 0 F U 0 0 0 0 0 0 0 0 0 0 0
2 - 0 0 0 0 0 U 0 F U 0 F U 0 F U 0 0 0 0 0 0 0 0 0 0 0
2 - 1 0 0 0 0 0 F U 0 F U 0 F U 0 0 0 0 0 0 0 0 0 0 0
2 - 2 0 0 0 0 0 F U 0 F U 0 F U 0 0 0 0 0 0 0 0 0 0 0

0 = no signs of systemic toxicity

F = Faeces stained blue

U = Urine stained blue

* = Bedding stained blue

Individual Bodyweights and bodyweight changes

Animal number Bodyweight (g) at day Bodyweight gain (g) during week
Day 1 Day 7 Day 14 1 2
1 - 0 214 239 256 25 17
1 - 1 200 217 237 17 20
1 - 2 211 241 268 30 27
2 - 0 203 226 243 23 17
2 - 1 203 237 249 34 12
2 - 2 186 226 240 40 14

Individual Necropsy Findings

Animal number Macroscopic observations
1-0 Kidneys: stained green
1-1 Liver: dark, Kidneys: stained green
1-2 Kidneys: stained green
2-0 Kidneys: stained green
2-1 Kidneys: stained green
2-2 Kidneys: stained green

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC 1272/2008)
Conclusions:
LD50 > 2000 mg/kg bw
Executive summary:

The present study was carried out to assess acute toxicity following a single oral administration to rats of the test substance to Sprague-Dawley CD strain rats, according to OECD Guideline 423. A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bw. This was followed by a further group of three fasted females at the same dose level. The test material was administered orally as a solution in distilled water. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.

At the end of the study period, there was no mortality and no signs of systemic toxicity. No significant macroscopic alterations were observed in any of the major organs of the examined animals. Under the test conditions, LD50 was estimated to be greater than 2000 mg/kg bw.

Conclusion

LD50 > 2000 mg/kg bw