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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:
From January 22, 2008 to May 07, 2008
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Qualifier:
according to
Guideline:
EPA OPPTS 870.1100 (Acute Oral Toxicity)
Principles of method if other than guideline:
- Japanese Ministry of Agriculture, Forestry and Fisheries
(JMAFF), 12 Nousan, Notification No 8147, November 2000,
including the most recent partial revisions.
GLP compliance:
yes
Test type:
acute toxic class method

Test material

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

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Crl:WI (Han)
Sex:
female
Details on test animals and environmental conditions:
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: about 9 week old
- Housing: three animals per cage
- Water: ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 21 ± 3 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12-hrs dark / 12-hrs light cycle

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Doses:
2000 mg/kg body weight
No. of animals per sex per dose:
three females for each dose group

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Table 1. Mortality data

Test day

1

1

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

Hours after treatment

0

2

4

 

Females 2000 mg/kg

Females 2000 mg/kg

Table 2. Clinical signs

Test day

 

1

1

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

Hours after treatment

Max grade

0

2

4

 

Females 2000 mg/kg

Animal 1

Posture

Hunched posture

(1)

1

1

Various

Red (Faeces)

(1)

1

Animal 2

Posture

Hunched posture

(1)

1

1

1

Various

Red (Faeces)

(1)

1

Animal 3

Posture

Hunched posture

(1)

1

1

1

Various

Red (Faeces)

(1)

1

Females 2000 mg/kg

Animal 4

Posture

Hunched posture

(1)

1

1

1

Skin/fur/plumage

Piloerection

(1)

1

1

Various

Red (Faeces)

(1)

1

Animal 5

Posture

Hunched posture

(1)

1

1

1

Skin/fur/plumage

Piloerection

(1)

1

Various

Red (Faeces)

(1)

1

Animal 6

Posture

Hunched posture

(1)

1

1

1

Skin/fur/plumage

Piloerection

(1)

1

Various

Red (Faeces)

(1)

1

Table 3. Body weight (g)

Sex/Dose level

Animal

Day 1

Day 8

Day 15

Females 2000 mg/kg

 

1

167

185

196

2

171

191

204

3

164

183

190

Mean

167

186

197

St. Dev.

4

4

7

N

3

3

3

Females 2000 mg/kg

 

4

156

169

171

5

163

182

184

6

168

183

196

Mean

162

178

184

St. Dev.

6

8

13

N

3

3

3

Table 4. Macroscopic findings

Animal organ

Finding

Day of death

Females 2000 mg/kg

1

No findings noted

Scheduled necropsy

Day 15 after treatment

2

No findings noted

Scheduled necropsy

Day 15 after treatment

3

No findings noted

Scheduled necropsy

Day 15 after treatment

Females 2000 mg/kg

4

No findings noted

Scheduled necropsy

Day 15 after treatment

5

No findings noted

Scheduled necropsy

Day 15 after treatment

6

No findings noted

Scheduled necropsy

Day 15 after treatment

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 423 test method, the LD50 cut-off value of Everzol Red CDN Crude was greater than 5000 mg/kg B.W.. Therefore, Everzol Red CDN Crude was Category 5 based on GHS criteria.
Executive summary:

This test using the procedures outlined in the NOTOX Study Plan for 487476.Everzol Red CDN Crude was administered by oral gavage to two subsequent groups of three female Wistar rats at 2000 mg/kg body weight. All animals were noted that hunched posture and/or piloerection on Day 1 and red faeces on Day 2. The body weight gain of all rats over the study period were considered to be similar to that expected of normal untreated animals of the same age and strain. No mortality occurred. No abnormalities were found at macroscopic post mortem examination of the animals. Therefore, the oral LD50 value of Everzol Red CDN Crude in Wistar rats was established to exceed 2000 mg/kg body weight.