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Key value for chemical safety assessment

Effects on fertility

Description of key information
In a reproductive/developmental screening test (oral administration of 50; 100; 1000 mg/kg bw ) in rats no indication of adverse effects on  development was noted. This is supported in a read across approach data were considered from studies  performed with the disodium salt of sebacic acid the C10 analog of dodecandioic acid with both rats and rabbits at dose levels of 500 and 1000 mg/kg bw/d, for rats and rabbits respectively. 
Effect on fertility: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The key study was the only study available and was a read across study from dodecanedioic acid (CAS 693-23-2). The key study was the only study available and was a read across study from dodecanedioic acid (CAS 693-23-2). The key study was given a reliability Klimisch score of 2. When assessed the overall quality of the database is high. This decreases the uncertainty in the prediction of the NOAEL for tridecanedioic acid (CAS No. 505-52-2).
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available
Additional information

No adverse effects on fertility were noted in a combined repeat dose reproductive toxicity test.

Also no adverse effects were noted on reproductive organs in other repeated dose studies.

There is no reproductive toxicity data available for tridecanedioic acid (CAS No. 505-52-2) A read-across approach was conducted with data from a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test from dodecanedioic acid (CAS 693-23-2).


Short description of key information:
Read across from dodecanedioic acid (CAS 693-23-2) - Combined Repeated Dose Toxicity Study with Reproduction/Developmental Toxicity Screening Test, NOAEL (parent): 1000 mg/kg bw/day; OECD 422, GLP)

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Justification for selection of Effect on fertility via oral route:
Only 1 key study available.

Effects on developmental toxicity

Description of key information
Reproductive/developmental screening test (oral administration of 50; 100; 1000 mg/kg bw ) was performed in rats. No indication of adverse effects on  development. 
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
The key study was the only study available and was a read across study from dodecanedioic acid (CAS 693-23-2). The key study was the only study available and was a read across study from dodecanedioic acid (CAS 693-23-2). The key study was given a reliability Klimisch score of 2. When assessed the overall quality of the database is high. This decreases the uncertainty in the prediction of the NOAEL for tridecanedioic acid (CAS No. 505-52-2).
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

No developmental toxicity as observed in a screening test in rats at dose levels of up to 1000 mg/kg bw/day (4.3 mmol/kg bw/day) dodecanedioic acid.


Justification for selection of Effect on developmental toxicity: via oral route:
Only 1 key study available.

Toxicity to reproduction: other studies

Additional information

No developmental toxicity was observed in a screening test in rats at dose levels of up to 1000 mg/kg bw/day (4.3 mmol/kg bw/day) dodecanedioic acid. This observation is supported by read-across to developmental toxicity studies with the disodium salts of C10 -homologue dicarboxylic acid, decanedioic acid (sebacic acid), at dose levels of 500 mg/kg bw/day (2.0 mmol/kg bw/day corresponding to 460.6 mg/kg bw/day dodecanedioic acid) in rats and 1000 mg/kg bw/day (4.06 mmol/kg bw/day corresponding to 935 mg/kg bw/day dodecanedioic acid) in rabbits where also a lack of developmental toxicity was demonstrated.

 The complete read across justification is attached as document.

Justification for classification or non-classification

No adverse effects were noted on fertility or development, therefore no classification regarding reproductive toxicity is required.