Sebacic acid

Endpoint summary

Description of key information

No mortality was observed in the acute oral toxicity studies in rats and rabbits, which were performed similar to OECD 401 with the analogue substance disodium sebacate (CAS 17265-14-4) and with the test substance sebacic acid.

No LD50 could be determined up to the top dose of 5000 mg/kg bw.

No mortality was observed in the acute dermal toxicity study with rabbits, performed according to OECD 402. No LD50 could be determined up to a top dose of 2000 mg/kg bw.

No reliable information are available for the acute inhalation toxicity route.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute 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

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Mortality:

No substance related mortality was seen.

Interpretation of results:

GHS criteria not met

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

ORAL

Three oral studies were performed with the analogue substance disodium sebacate (CAS 17265-14-4), which is the sodium salt of sebacic acid:

In the key study, male and female Sprague-Dawley rats were administered by gavage with disodium sebacate. The study was performed with a limit dose of 5000 mg/kg bw/d with 5 animals of each sex for 14 days. The LD50 was found to be > 5000 mg/kg bw/d.

In the two supporting studies, male and female Wistar rats and New Zealand rabbits received unchangend disodium sebacate (500 up to 5000/6000 mg/kg bw with 4 animals per group); the control groups received NaCl solution. No substance related mortality or clinical signs were seen. Therefore, the LD50 was concluded to be above 5000/6000 mg/kg bw.

In the supporting study with sebacic acid, two male Sprague-Dawley rats were administered by gavage as the limit dose of 5000 mg/kg bw/d. No mortality was observed in the study and the LD50 was > 5000 mg/kg bw/d.

DERMAL

In the key GLP study, which was done according to the OECD guideline 402, 5 male and female rabbits were semiocclusively exposed to 2000 mg sebacic acid/kg bw for 24 h. No animals died and no general or local clinical signs or body weight abnormalities were observed during the observation period of 15 days. Additionally, no macroscopic findings were evident at the final autopsy. Therefore, the LD50 by dermal route is higher than 2000 mg/kg.

INHALATION

No reliable information is available for this route.

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 acute toxicity under Regulation (EC) No. 1272/2008.