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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 202-996-4 | CAS number: 102-01-2
Specific investigations: other studies
Administrative data
- Endpoint:
- methaemoglobinaemia
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented study report which meets basic scientific principles. Study was conducted prior to GLP implementation.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 978
- Report date:
- 1978
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Oral application of 100mg/kg to two female cats. Hematological examinations were made before and after treatment.
- GLP compliance:
- no
- Remarks:
- prior to GLP implementation
- Type of method:
- in vivo
Test material
- Reference substance name:
- Acetoacetanilide
- EC Number:
- 202-996-4
- EC Name:
- Acetoacetanilide
- Cas Number:
- 102-01-2
- Molecular formula:
- C10H11NO2
- IUPAC Name:
- 3-oxo-N-phenylbutanamide
- Details on test material:
- - Name of test material (as cited in study report): Acetessiganilid TTR
Constituent 1
Test animals
- Species:
- cat
- Strain:
- not specified
- Sex:
- female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: mucous starch (2%)
- Details on exposure:
- - single oral administration (gavage)
- 10% concentration of Acetessiganilid TTR in mucous starch (2%)
- dose level: 100 mg/kg bw
- examination before and 1, 3, 7, 24, 48, 72, and 96h, and 7, 14, 28 d post application. - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- - Single application by gavage
- examination before and 1, 3, 7, 24, 48, 72, and 96h, and 7, 14, 28 d post application. - Frequency of treatment:
- Once
- Post exposure period:
- 28 d (blood sampling: 1h, 3h, 7h, 24h, 48h, 72h, 96h, 7d, 14d, 28d post application)
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 2 females
Examinations
- Examinations:
- Haematology: Haemoglobin, erythrocyte count, leucocyte count, haematocrit, haemogram, MetHb-formation, Heinz bodies
Results and discussion
- Details on results:
- Immediately after application both cats experienced increased salivation, 1hr p.a. an increased breathing frequency was observed as well as signs of cyanosis and vertigo. One cat vomited 1hr and 4.5hrs p.a.. Body weight gain was slightly reduced in both cats.
Application of 100mg/kg bw of Acetoacetanilide TTR caused formation of metheamoglobine and Ehrlich-Heinz-bodies.
Any other information on results incl. tables
|
|
Cat no. 1 |
Cat no. 2 |
|||||
Dose (mg/kg bw) |
Time post application |
MetHb (%)
|
Hb (%) |
Heinz bodies (%) |
MetHb (%)
|
Hb (%) |
Heinz bodies (%) |
|
100 |
control |
0 |
14.0 |
0.5 |
0 |
12.3 |
3.5 |
|
1h |
5.6 |
15.1 |
1.5 |
7.7 |
13.4 |
7.5 |
||
3h |
8.9 |
14.3 |
1.5 |
9.7 |
12.8 |
7.5 |
||
7h |
7.9 |
13.4 |
49.0 |
9.6 |
12.5 |
54.5 |
||
24h |
0.7 |
14.3 |
90.5 |
1.6 |
14.1 |
93.5 |
||
48h |
0.9 |
16.1 |
50.5 |
0.6 |
14.8 |
91.0 |
||
72h |
0.6 |
15.2 |
73.0 |
0.7 |
13.1 |
85.5 |
||
96h |
0.9 |
15.8 |
71.5 |
0 |
13.7 |
86.0 |
||
7d |
0.6 |
13.5 |
56.5 |
0.3 |
13.1 |
73.0 |
||
14d |
|
13.6 |
56.5 |
|
13.0 |
46.0 |
||
21d |
|
14.4 |
7.5 |
|
13.3 |
7.0 |
||
28d |
|
13.6 |
3.5 |
|
13.5 |
1.0 |
||
Applicant's summary and conclusion
- Conclusions:
- Data show that the test item causes MetHb and Heinz body formation. Data support the conclusion that MetHb related lethality may occur at doses higher than 100 mg/kg bw.
With respect to MetHb forming substances cats are known to react with higher sensitivity than humans. Based on the expected lethal dose of >100 mg/kg bw for the cat, the human acute toxic dose is estimated to be not higher than 2000 mg/kg bw. - Executive summary:
In order to assess the methaemoglobin-forming potential of Acetessiganilid TTR 2 cats received single oral doses of 100 mg/kg bw. Hematological examinations were made before and after treatment.
Immediately following application both cats experienced increased salivation, 1hr p.a. an increased breathing frequency was observed as well as signs of cyanosis and vertigo. One cat vomited 1hr and 4.5hrs p.a.. Body weight gain was slightly reduced in both cats. Application of 100mg/kg bw of Acetoacetanilide TTR caused formation of metheamoglobine and Ehrlich-Heinz-Bodies.
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.
