Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 200-186-5 | CAS number: 53-86-1
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: acceptable publication, comparable to guideline studies
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Indometacin
- EC Number:
- 200-186-5
- EC Name:
- Indometacin
- Cas Number:
- 53-86-1
- Molecular formula:
- C19H16ClNO4
- IUPAC Name:
- 2-[1-(4-chlorobenzoyl)-5-methoxy-2-methyl-1H-indol-3-yl]acetic acid
Constituent 1
Administration / exposure
- Control animals:
- no
Results and discussion
Any other information on results incl. tables
Species (Strain) |
Way of administration |
Sex |
LD50 mg/kg bw (Confidence Interval) |
Lowest toxic dose (mg/kg bw) |
Remarks |
Mouse (CF 1 W 68) |
i.m. |
M |
18.2 (11.8 – 25.4) |
10 |
Ascites, reddened intestinal mucosa, slight body weight reduction, death within one week after administration |
|
s.c. |
M |
18.3 (12.8 – 18.3) |
10 |
Severe body weight loss, mortality with first week after administration |
|
i.p. |
M |
19.6 (9.7 – 29.8) |
10 |
mortality with first week after administration, symptoms of intoxication as described before |
|
|
F |
28.5 (18.2 – 72.0) |
7 |
Reddened mucosa, ascites, dark discolored liver and spleen, body weight loss in a part of the animals |
Rat (Wistar TNO 75) |
i.m. |
M |
26.3 (19.6 – 35.3) |
15 |
Body weight loss for more than 2 weeks (especially at high doses), severely reddened intestinal mucosa, mucous ascites, no local reactions |
|
s.c. |
M |
25.2 (18.7 – 34.2) |
18 |
Body weight loss (high doses), recovery of body weights in surviving animals of low dose groups only within 3 weeks after administration, at necropsy ascites, distended stomach, mucous secretion in abdominal cavity, no local reaction at administration site |
|
i.p. |
M |
35.1 (23.9 – 49.2) |
20 |
Severe body weight loss, mortality within 2 weeks after administration, ascites |
|
i.p. |
F |
17.3 (14.0 – 21.1) |
14 |
As in males |
(12 weeks old) |
i.p. |
M |
30.9 (0.0 – 57.3) |
20 |
Mortality in the first and second week after administration, |
Guinea pig (Pirbright) |
i.p. |
F |
143 (71 – 276) |
80 |
Mortality in the first and second week after administration |
Dog (Bastard dogs) |
i.v. |
M |
100 - 200 |
- |
At 100 mg/kg: vomitus, long lasting body weight reduction (> 3 weeks after administration) At 200 mg/kg: vomitus, stupor, mortality about 6 days after administration; at necropsy brown discolored ascites |
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
