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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
50 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
adequate
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

see discussion below


Short description of key information:
No adverse reproductive effects seen in an OECD 421 test, at the dose of 50 mg/kg bw/d tripropenyl succinic anhydride, which was a NOAEL for subacute general toxicity.

Justification for selection of Effect on fertility via oral route:
guideline study under GLP

Effects on developmental toxicity

Description of key information
No developmental effects seen at the highest dose tested, 250 mg/kg bw/d, in an OECD 421 test with tripropenyl succinic anhydride.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
250 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
adequate
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

see discussion below.


Justification for selection of Effect on developmental toxicity: via oral route:
guideline study under GLP

Toxicity to reproduction: other studies

Additional information

No reproductive effects were observed in parental reproductive organs or performance after exposure to tripropenyl succinic anhydride, a member of the C8 -C12 alkenyl succinic anhydride category. The general NOAEL was 50 mg/kg bw/d for body weight effects; the NOAEL for reproductive effects could be higher. No adverse effects were observed in offspring at the highest dose tested in an OECD 421 guideline study under GLP. 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 reproductive toxicity risk. The human health risks which were identified pertained to the immediate reactivity of the anhydride group, which manifests as irritation and sensitisation. There is no data which suggests that additional testing for reproductive toxicity is indicated. It is proposed that any additional testing be conducted on the cleavage product of the anhydride, as the substance is 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 reproductive toxicity.

Justification for classification or non-classification

No reproductive effects were observed in parental reproductive organs or performance after exposure to tripropenyl succinic anhydride, a member of a chemical category which also included dodecenyl succinic anhydride. No adverse effects were observed in offspring at the highest dose tested in an OECD 421 guideline study under GLP. There is currently insufficient evidence to require classification for reproductive toxicity.

Additional information