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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
1 021 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

The registered substance is a member of the Selected Cyclic Acid Anhydrides category. The required registration data on reproductive toxicity is provided by a category member, phthalic acid. In a teratology study by Ema et al., 1997, phthalic acid did not cause reproductive or developmental toxicity in rats when administered during the organogenesis period of gestation. In support of a lack of targeted reproductive toxicity, expert groups at the WHO, 2009, reviewed the available repeated dose toxicity studies of several cyclic acid anhydrides, and concluded that systemic and reproductive toxicities are not observed. There is no evidence in repeated dose toxicity studies of adverse histopathological effects in reproductive or endocrine organs. Toxicokinetic behaviour favors rapid conversion of anhydrides to the acid form and subsequent urinary excretion. Reproductive toxicity is not one of the critical health effects of exposure to cyclic acid anhydride.

The category of cyclic acid anhydrides is based on the member having similar chemical behaviour and analogous breakdown products in environmental and biological systems. The common functional group is a 1,3-dioxo-1,3-dihydro-2-furan ring (i. e., a cyclic acid anhydride) directly attached to an aromatic ring. The cyclic anhydride moiety is quickly hydrolysed to form a dioic acid. The cyclic acid anhydride moiety and its dioic acid derivatives are the principal loci of toxicity, rather than the remainder of the molecule. Within the category, oligomeric forms of the cyclic acid anhydrides are less likely to be absorbed across biological membranes than the simple, monomeric forms, so that this read-across represents the worst case scenario. The read-across information to acceptable to fulfil the information requirements of the REACH Annexes VII-X, to be the basis for classification and labelling decisions, and for risk assessment.

Short description of key information:
Members of the Selected Cyclic Acid Anhydrides category are not reproductive or developmental toxicants.

Justification for selection of Effect on fertility via oral route:
experimental data on a member of the Selected Cyclic Acid Anhydrides category

Effects on developmental toxicity

Description of key information
Members of the Selected Cyclic Acid Anhydrides category are not reproductive or developmental toxicants.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 763 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

The registered substance is a member of the Selected Cyclic Acid Anhydrides category. The required registration data on reproductive toxicity is provided by a category member, phthalic acid. In a teratology study by Ema et al., 1997, phthalic acid did not cause reproductive or developmental toxicity in rats when administered during the organogenesis period of gestation. In support of a lack of targeted reproductive toxicity, expert groups at the WHO, 2009, reviewed the available repeated dose toxicity studies of several cyclic acid anhydrides, and concluded that systemic and reproductive toxicities are not observed. There is no evidence in repeated dose toxicity studies of adverse histopathological effects in reproductive or endocrine organs. Toxicokinetic behaviour favors rapid conversion of anhydrides to the acid form and subsequent urinary excretion. Reproductive toxicity is not one of the critical health effects of exposure to cyclic acid anhydride.

The category of cyclic acid anhydrides is based on the member having similar chemical behaviour and analogous breakdown products in environmental and biological systems. The common functional group is a 1,3-dioxo-1,3-dihydro-2-furan ring (i. e., a cyclic acid anhydride) directly attached to an aromatic ring. The cyclic anhydride moiety is quickly hydrolysed to form a dioic acid. The cyclic acid anhydride moiety and its dioic acid derivatives are the principal loci of toxicity, rather than the remainder of the molecule. Within the category, oligomeric forms of the cyclic acid anhydrides are less likely to be absorbed across biological membranes than the simple, monomeric forms, so that this read-across represents the worst case scenario. The read-across information to acceptable to fulfil the information requirements of the REACH Annexes VII-X, to be the basis for classification and labelling decisions, and for risk assessment.

Justification for selection of Effect on developmental toxicity: via oral route:
experimental data on a member of the Selected Cyclic Acid Anhydrides category

Justification for classification or non-classification

There is no evidence of reproductive toxicity of members of the selected cyclic acid anhydrides category. The criteria for classification for reproductive toxicity in Regulation EC No. 1272/2008 are not met.

Additional information