Registration Dossier
Registration Dossier
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EC number: 213-116-3 | CAS number: 925-21-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
The oral administration of Butyl Hydrogen Maleate to rats by gavage, at dose levels of 175, 100 and 30 mg/kg bw/day, resulted in treatment-related changes at all dose levels. A ‘No Observed Effect Level’ (NOEL) for systemic toxicity could therefore not be established.
The effects detected at 100 and 30 were considered not to represent an adverse effect, therefore the ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was considered to be 100 mg/kg bw/day.
There were no treatment-related effects detected on the reproductive parameters investigated, therefore the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 175 mg/kg bw/day.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 175 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Effect on fertility: via inhalation route
- Endpoint conclusion:
- no study available
Effect on fertility: via dermal route
- Endpoint conclusion:
- no study available
Additional information
The test item was administered by gavage to three groups, each of twelve male and twelve female Wistar Han™:RccHan™:WIST strain rats, for up to eight weeks (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 30, 100 and 175 mg/kg bw/day. A control group of twelve males and twelve females was dosed with vehicle alone.
The oral administration of Butyl Hydrogen Maleate to rats by gavage, at dose levels of 175, 100 and 30 mg/kg bw/day, resulted in treatment-related changes at all dose levels. A ‘No Observed Effect Level’ (NOEL) for systemic toxicity could therefore not be established.
The effects detected at 100 and 30 were considered not to represent an adverse effect, therefore the ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was considered to be 100 mg/kg bw/day.
There were no treatment-related effects detected on the reproductive parameters investigated, therefore the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 175 mg/kg bw/day.
Effects on developmental toxicity
Description of key information
The oral administration of Butyl Hydrogen Maleate to rats by gavage, at dose levels of 175, 100 and 30 mg/kg bw/day, resulted in treatment-related changes at all dose levels. A ‘No Observed Effect Level’ (NOEL) for systemic toxicity could therefore not be established.
The effects detected at 100 and 30 were considered not to represent an adverse effect, therefore the ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was considered to be 100 mg/kg bw/day.
There were no treatment-related effects detected on the reproductive parameters investigated, therefore the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 175 mg/kg bw/day.
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- subacute
- Species:
- rat
Additional information
The test item was administered by gavage to three groups, each of twelve male and twelve female Wistar Han™:RccHan™:WIST strain rats, for up to eight weeks (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 30, 100 and 175 mg/kg bw/day. A control group of twelve males and twelve females was dosed with vehicle alone.
The oral administration of Butyl Hydrogen Maleate to rats by gavage, at dose levels of 175, 100 and 30 mg/kg bw/day, resulted in treatment-related changes at all dose levels. A ‘No Observed Effect Level’ (NOEL) for systemic toxicity could therefore not be established.
The effects detected at 100 and 30 were considered not to represent an adverse effect, therefore the ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was considered to be 100 mg/kg bw/day.
There were no treatment-related effects detected on the reproductive parameters investigated, therefore the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 175 mg/kg bw/day.
Justification for classification or non-classification
Based on the results of the above study the test material can be considered not to be classified for reproduction and developmental toxicity.
Additional information
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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