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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
50 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
Adequate

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Repeated dose toxicity effects were observed at 150 mg/kg bw/day after 28-days of oral exposure to a chemical category member, tripropenyl succinic anhydride (TSA). The NOAEL was 50 mg/kg bw/d. The WHO reviewed the human health risks of cyclic acid anhydrides, and, while data are limited, did not find a weight of evidence which suggests repeated dose exposure represents a health risk. Human health risks were identified, and these pertain to the immediate reactivity of the anhydride group (irritation and sensitisation). Risk management measures are recommended to minimize acute exposures.

It is proposed that, if any additional testing is needed, it be conducted on the more water-soluble cleavage product of the anhydride, as all the anhydrides are hydrolytically labile.

A chemical category is established for alkenyl succinic anhydrides with C8-C12 alkenyl side chains, based on common functional groups, similar physico-chemical properties, common breakdown/metabolic products via physical and biological processes, and a constant pattern in the changing of the potency across the category.  These include tetrapropenyl succinic anhydride (CAS 26544-38-7), octenyl succinic anhydride (CAS 26680-54-6), n-dodecenyl succinic anhydride (CAS 19780-11-1) and tripropenyl succinic anhydride (CAS 28928-97-4). Common functional groups are a dihydro-2,5 -furandione (cyclic anhydride) ring, a carbon chain of length 8 to 12 carbons (with or without branching methyl groups), and one double bond in the carbon chain, location unspecified. Common breakdown products are the dioic acids of the corresponding anhydride. A constant pattern may also be displayed in acute toxicity, dermal irritancy and biodegradation, with the lowest carbon chain length (C8) displaying the highest irritation potential in vivo and highest biodegradation potential. Irritation and degradation diminishes with increasing carbon chain length. Read-across is appropriate to fill the data gaps for repeated dose toxicity.


Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:
guideline study under GLP on a category member

Justification for classification or non-classification

No findings from repeated dose toxicity testing of a category member, tripropenyl succinic anhydride, meet criteria for classifcation of specific target organ toxicity-repeated exposure. There is currently insufficient evidence to require classification according to Regulation EC No. 1272/2008.