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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-571-6 | CAS number: 108-31-6
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 3 (not reliable)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Referenceopen allclose all
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 953
- Report date:
- 1953
- Reference Type:
- review article or handbook
- Title:
- Maleic Anhydride and Maleic Acid, SIDS Initial Assessment Report For SIAM 18
- Author:
- OECD SIDS
- Year:
- 2 004
- Bibliographic source:
- OECD SIDS Initial Assessment Report For SIAM 18, Paris, France, 20-23 April 2004
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- One cat, one rabbit, one guinea pig, four rats and ten mice were exposed to a saturated maleic anhydride atmosphere for one hour.
- GLP compliance:
- no
- Test type:
- fixed concentration procedure
- Limit test:
- no
Test material
- Reference substance name:
- Maleic anhydride
- EC Number:
- 203-571-6
- EC Name:
- Maleic anhydride
- Cas Number:
- 108-31-6
- Molecular formula:
- C4H2O3
- IUPAC Name:
- 2,5-dihydrofuran-2,5-dione
- Details on test material:
- - Name of test material (as cited in study report): Maleinsaeureanhydrid
- Analytical purity: 98.5 - 99.3 %
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- not specified
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure:
- not specified
- Details on inhalation exposure:
- Animals were exposed to a static atmosphere of maleic anhydride.
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 1 h
- Concentrations:
- 4.35 mg/L nominal
- No. of animals per sex per dose:
- 4
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 6-8 days
- Other examinations performed: clinical signs
Results and discussion
Effect levels
- Key result
- Sex:
- not specified
- Dose descriptor:
- LC50
- Effect level:
- > 4.35 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 1 h
- Remarks on result:
- other: no mortality and no clinical signs observed
- Mortality:
- no mortality observed
- Clinical signs:
- other: no clinical signs observed.
Any other information on results incl. tables
The study was also conducted on one cat, one rabbit and one guinea pig exposed to saturated vapor of 4.35 mg maleic anhydride/L at 56°C for 1 hour and were observed for 6-8 days. No mortality was observed in the cat. However,2 h after the exposure lacrimal fluid, closing of eyes and redness of conjuctiva were observed. No mortality was observed in the rabbit. However, 2 min after dosingcleaning of moustache and redness of conjuctiva were observed. And the guinea pig died after 8 days. However no clinical signs were observed in the animal.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Based on the results the LC50 value in rats was determined to be higher than 4.35 mg/L air. Furthermore, under the conditions of this experiment, the study cannot be used for classification.
- Executive summary:
In an acute inhalation study, one cat, one rabbit, one guinea pig, four rats, ten mice were exposed to saturated vapor of 4.35 mg maleic anhydride/L at 56°C for 1 hour and were observed for 6-8 days. No mortality and no clinical signs were observed in rats. Based on the results the LC50 value in rats was determined to be higher than 4.35 mg/L air.
The study was also conducted on one cat, one rabbit and one guinea pig exposed to saturated vapor of 4.35 mg maleic anhydride/L at 56°C for 1 hour and were observed for 6-8 days. No mortality was observed in the cat. However,2 h after the exposure lacrimal fluid, closing of eyes and redness of conjuctiva were observed.No mortality was observed in the rabbit. However, 2 min after dosingcleaning of moustache and redness of conjuctiva were observed. And theguinea pig died after 8 days. However no clinical signs were observed in the animal.
Furthermore, under the conditions of this experiment, the study cannot be used for classification.
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.
