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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

No mortality or adverse effects were observed in oral toxicity studies in rats and rabbits, which were performed similar to OECD 408 and OECD 409 with the analogue substance disodium sebacate (CAS 17265-14-4). One pre-GLP study is available with the test substance sebacic acid. No adverse effects were observed in this study performed in rats.

No NOAEL could be determined up to the top doses: 1000 (rats) / 1500 (rabbits) mg/kg bw/d.

No reliable information are available for effects via the inhalation route.

No reliable information are available for effects via the dermal route.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Link to relevant study records
Reference
Endpoint:
chronic toxicity: oral
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
The justification for the type of information are discussed in the attached read-across document.
Reason / purpose for cross-reference:
read-across source
Dose descriptor:
NOEL
Effect level:
>= 1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
female
Basis for effect level:
other: no effects reported
Critical effects observed:
no
Conclusions:
When compared to the control animals, no significant differences in biological parameters (clinical, chemical and haematological values, growth curves and histological findings for the different organs) were observed in the test groups during the treatment period in a study performed with the analogue disodium sebacate.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat

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

ORAL:

In the published subchronic key study, 10 rats per sex and dose - and also rabbits - were orally exposed to the analogon disodiuam sebacate (CAS 17265-14-4) for 6 months; rats: 500 and 1000 mg/kg bw/d, rabbits: 750 and 1500 mg/kg bw/d. No death or qualitative toxic clinical signs were observed. Food and water consumption, body weight gain, histology and clinical chemistry were similar to control.

In a supporting pre-GLP study 5 young and 3 adult rats were orally exposed to sebacic acid for 4 weeks (young: about 4814 mg/kg bw/day; adult: about 3367 mg/kg bw/day). No influence on the body weight gain, behaviour and no adverse clinical effects were observed.

DERMAL:

No information available.

INHALATION:

No information available.

Justification for classification or non-classification

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008, as amended for the thirteenth time in Regulation (EU) No 2018/1480. As a result the substance is not considered to be classified for repeated dose toxicity under Regulation (EC) No. 1272/2008.