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EC number: 218-566-4 | CAS number: 2184-11-4
Endpoint summary
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
- 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.
- 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..
Reference
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 |
||
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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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