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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:
December from 05th to 28th, 2000
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
The complete study report is not available, thus some details about test conditions are missing.
Justification for type of information:
Justification for read-across is detailed in the report attached to the IUCLID section 13.
Cross-reference
Reason / purpose:
read-across source
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December from 05th to 28th, 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions
Remarks:
The complete study report is not available, thus some details about test conditions are missing.
Justification for type of information:
Justification for read-across is detailed in the report attached to the IUCLID section 13.
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 22 March 1996
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Fasting period before study: fasted animals.
Route of administration:
oral: unspecified
Vehicle:
arachis oil
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Three females and three males.
Details on study design:
Clinical signs and bodyweight development were monitored during the study.
All animals were subjected to gross necropsy.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs and bodyweight development were monitored during the study.
- Necropsy of survivors performed: yes, all animals were subjected to gross necropsy.
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No deaths occurred.
Clinical signs:
No signs of systemic toxicity were noted during the study. The faeces of the females were stained orange on day 1.
Gross pathology:
No abnormalities detected.

Individual bodyweight and weekly bodyweight changes

Dose level
(mg/kg bw)
Animal N. and sex Bodyweight (g) at day Bodyweight gain (g) during week
0 7 14 1 2
2000 1-0 female 217 262 286 45 24
1-1 female 214 255 277 41 22
1-2 female 211 258 276 47 18
2-0 male 285 338 377 53 39
2-1 male 299 376 420 77 44
2-2 male 273 332 366 59 34
Interpretation of results:
other: not classified, according to the CLP Regulation (EC) No 1272/2008
Conclusions:
LD50 > 2000 mg/kg bw (males and females)
Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley rat. The method followed the OECD Guideline 423 (adopted 22 March 1996), EU Commission Directive 96/54/EEC method B1. A group of three fasted females was treated with 2000 mg/kg bodyweight; this was followed by a group of three fasted animals of the other sex at the same dose level. The test material was administered orally as a suspension in arachis oil BP.

No deaths occurred and no signs of systemic toxicity were noted during the study. The faeces of the females were stained orange on day 1. Necropsy did not revealed abnormalities.

Conclusion

LD50 > 2000 mg/kg bw (males and females)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Version / remarks:
adopted 22 March 1996
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Fasting period before study: fasted animals.

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
arachis oil
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
Three females and three males.
Details on study design:
Clinical signs and bodyweight development were monitored during the study.
All animals were subjected to gross necropsy.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs and bodyweight development were monitored during the study.
- Necropsy of survivors performed: yes, all animals were subjected to gross necropsy.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Remarks on result:
not determinable due to absence of adverse toxic effects
Mortality:
No deaths occurred.
Clinical signs:
No signs of systemic toxicity were noted during the study. The faeces of the females were stained orange on day 1.
Gross pathology:
No abnormalities detected.

Any other information on results incl. tables

Individual bodyweight and weekly bodyweight changes

Dose level
(mg/kg bw)
Animal N. and sex Bodyweight (g) at day Bodyweight gain (g) during week
0 7 14 1 2
2000 1-0 female 217 262 286 45 24
1-1 female 214 255 277 41 22
1-2 female 211 258 276 47 18
2-0 male 285 338 377 53 39
2-1 male 299 376 420 77 44
2-2 male 273 332 366 59 34

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC) No 1272/2008
Conclusions:
LD50 > 2000 mg/kg bw (males and females)
Executive summary:

The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley rat. The method followed the OECD Guideline 423 (adopted 22 March 1996), EU Commission Directive 96/54/EEC method B1. A group of three fasted females was treated with 2000 mg/kg bodyweight; this was followed by a group of three fasted animals of the other sex at the same dose level. The test material was administered orally as a suspension in arachis oil BP.

No deaths occurred and no signs of systemic toxicity were noted during the study. The faeces of the females were stained orange on day 1. Necropsy did not revealed abnormalities.

Conclusion

LD50 > 2000 mg/kg bw (males and females)