Registration Dossier

Diss Factsheets

Administrative data

Description of key information

In the acute oral test, the test dose was 5 g/kg b.w.. Result showed that all treated rats survived till the end of the study and there was no significant gross lesions founded during the gross necropsy examination.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2014-11-28~2014-12-12
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
GLP compliance:
yes
Test type:
up-and-down procedure
Limit test:
yes
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: gavage
Vehicle:
water
Doses:
5 g/kg b.w.
No. of animals per sex per dose:
Five male and five female
Control animals:
no
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.

Table 1 : Body weight of the rats

Animal I.D.

Dosing volume (mL)

Body weight (g)

Weight changes (g)

Day 1

Day 7

Day 14

Male

 

01

8.5

211.1

288.7

352.6

+141.5

02

8.6

214.4

285.1

330.3

+115.9

03

8.3

207.0

279.1

323.5

+116.5

04

8.8

219.2

307.2

371.4

+152.2

05

8.0

198.2

270.3

320.3

+122.1

Female

 

06

6.4

159.1

184.2

200.3

+41.2

07

6.8

167.9

204.8

235.3

+67.4

08

6.7

165.8

206.6

224.5

+58.7

09

6.3

157.5

183.7

197.5

+40.0

10

6.2

154.3

180.6

200.8

+46.5

Table 2 : Clinical observation of the rats

Animal I.D.

Clinical sign observation

30 mins

4 hours

D2

D3

D4

D5

D6

D7

D8

D9

D10

D11

D12

D13

D14

Male

 

01

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

02

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

03

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

04

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

05

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

Female

 

06

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

07

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

08

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

09

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

10

N

N

N

N

N

N

N

N

N

N

N

N

N

N

N

Table 3 : Results of gross necropsy examination

Animal I.D.

Dose

Gross lesion

Male

 

01

5 g/kg b.w.

No significant lesion founded

02

No significant lesion founded

03

No significant lesion founded

04

No significant lesion founded

05

No significant lesion founded

Female

 

06

5 g/kg b.w.

No significant lesion founded

07

No significant lesion founded

08

No significant lesion founded

09

No significant lesion founded

10

No significant lesion founded

Interpretation of results:
GHS criteria not met
Conclusions:
The test dose of this study was 5 g/kg b.w.. Result showed that all treated rats survived till the end of the study and there was no significant gross lesions founded during the gross necropsy examination.
Executive summary:

According to OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure), the median lethal dose (LD50) of test article was greater than 5 g/kg b.w..

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on these results, direct red 224 is not classified for acute toxicity according to CLP (EC1272/2008) and DSD (67/548/EEC).

Categories Display