Diisotridecyl adipate

Endpoint summary

Description of key information

Studies on repeated dose toxicity could not be identified for diisotridecyl adipate. Results for di-2-ethylhexyl adipate are used for read across. 
NOAELs have only been determined for oral application.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

NOAEL

200 mg/kg bw/day

Study duration:

subchronic

Species:

mouse

Quality of whole database:

Reliability 2

Organ:

other: decreased body weight gain

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Study duration:

subacute

Species:

rat

Quality of whole database:

Reliability 3

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Study duration:

subacute

Species:

rat

Quality of whole database:

Reliability 3

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Study duration:

subchronic

Species:

rat

Quality of whole database:

Reliability 4

Repeated dose toxicity: dermal - local effects

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Study duration:

subchronic

Species:

rat

Quality of whole database:

Reliability 4

Additional information

For assessment of the repeated dose toxicity no valid study could be identified with diisotridecyl adipate as test substance. An aerosol inhalation study (Mobil, 1989) had only a test period of 14 days and relevant parameters were not examined (RL3). But studies concerning repeated dose toxicity are available for di-2-ethylhexyl adipate and ditridecyl adipate as supporting substances. Studies available are presented in the following table.

 

Study	Guideline/ Method	Species/ Route	Duration	Doses	NOAEL
Supp. Substance DEHA
Miyata 2006	OECD 407	rat oral; gavage	28 days	40, 200,1000 mg/kg/day	200 mg/kg bw/day
NTP 1982	subchronic study	rat oral; diet	91 days	1600, 3100, 6300, 12500, 25000 ppm (6300 ppm = ca. 595 mg/kg bw/day)	551 (females) 630 (males) mg/kg bw/day
NTP 1982	subchronic study	mouse oral; diet	91 days	1600, 3100, 6300, 12500, 25000 ppm (1600 ppm = ca. 200 mg/kg bw/day)	200 mg/kg bw/day
NTP 1982	carcinogenesis study	rat oral; diet	103 weeks	12000, 25000 ppm (600, 1250 mg/kg bw/day)	600 mg/kg bw/day
NTP 1982	carcinogenesis study	mouse oral; diet	103 weeks	12000, 25000 ppm (1750, 3570 mg/kg bw/day)
Supp. Substance ditridecyl adipate
HPV TP 2003		rat dermal	90 days	800, 2000 mg/kg bw/day	not identified (no systemic toxicity)

 

In the NTP program, di-2-ethylhexyl adipate has been investigated thoroughly (subchronic and chronic studies, two species). The lowest NOAEL was determined for the 91 day study in mice based on reduced body weight gain. This value will be used to derive a NOAEL for diisotridecyl adipate.

Di-2-ethyhexyl adipate, a saturated branched chain aliphatic adipate diester, is used as supporting substances for read across based on the close structural relationship to diisotridecyl adipate as substantiated in more detail in the endpoint summary of Section 7.1.1 - Basic toxicokinetics.