Registration Dossier
Registration Dossier
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EC number: 904-976-7 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
No experimental data is available on the reaction mass of maleic acid and phthalic acid. The toxicological data available on maleic and phthalic acids, the main compounds (>1% w/w) contained in the reaction mass can be summarized as follow:
Maleic acid exhibits moderate acute toxicity by the oral and dermal routes, with the oral LD50 of 0.71 g/kg in rats and an acute dermal LD50 of 1.56 g/kg in rabbits. Maleic acid has been reported to be mildly irritating to the skin and severely irritating to the eyes of rabbits. Although no sensitization data exist for maleic acid, it is considered as a skin sensitizer. In an oral two-year study, male and female Osborne Mendel rats were given 0, 0.5, 1.0, or 1.5% maleic acid in their feed (approximately 0, 250, 500 and 750 mg/kg/day). Concentrations of 1.0 and 1.5% maleic acid retarded the growth rate and all concentrations of maleic acid increased mortality rates. The authors reported no major visceral damage, although rats fed 1.5% maleic acid showed more atrophy of the liver than controls.Maleic acid was negative in bacterial gene mutation tests.
Phthalic acid exhibits low acute toxicity by the oral route, with the oral LD50of 7.9 g/kg in rats. Phthalic acid is expected to be irritating to the skin, the eyes and the respiratory tract. Phthalic acid is not a skin sensitizer. Phthalic acid did not show evidence of genotoxicity; neither in bacterial mutation tests, nor in a chromosome aberration test in Chinese hamster ovary cells. Phthalic acid is not a developmental toxicant.
Based on these data, the reaction mass of maleic acid and phthalic acid is expected to be of low acute oral toxicity, slightly irritating for the skin and eyes and a skin sensitizer.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
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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