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Administrative data

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.

 

Justification for classification or non-classification