Registration Dossier
Registration Dossier
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EC number: 208-011-4 | CAS number: 505-52-2
Endpoint summary
Administrative data
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)
.
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.
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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