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Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
170 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Reliability 2
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
2 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Klimisch 4
Additional information

For the reproductive toxicity of diisotridecyl adipate, no study could be located. Information on reproductive toxicity, available for di-2-ethylhexyl adipate as supporting substance, is used for read across.

 Reproductive toxicity of di-2-ethylhexyl adipate was investigated in a One-generation reproduction toxicity study according to OECD TG 415 (Cefic, 1989). In a 28 day repeated dose toxicity study (OECD TG 407), reproductive organs of male and female animals were examined by necropsy and histopathology. In addition spermatogenesis and oestrous cycling was inspected (Miyata, 2006).

In the One-generation study, a reproductive NOAEL of 170 mg/kg bw/day was determined.

The reproductive NOAEL in the repeated dose toxicity study was 200 mg/kg bw/day.

 Di-2-ethyhexyl adipate is a saturated branched chain aliphatic adipate diester and closely related to diisotridecyl adipate. It is used as supporting substances for read across as justified in more detail in the attached read-across-document.

 


Short description of key information:
Studies on fertility using diisotridecyl adipate could not be located. Di-2-ethylhexyl adipate is used as supporting substance for read across.
In a One-generation reproduction toxicity study with di-2-ethylhexal adipate as test substance, a reproduction NOAEL of 170 mg/kg bw/day was determined for the P generation.

Effects on developmental toxicity

Description of key information
Studies on developmental toxicity/teratogenicity with diisotridecyl adipate as test substance could not be located. Di-2-ethylhexyl adipate is used as supporting substance for read across.
In a developmental toxicity study with di-2-ethylhexal adipate, a developmental NOAEL of 170 mg/kg bw/day was determined.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
adverse effect observed
Dose descriptor:
NOAEL
170 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Klimisch 2
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
800 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Quality of whole database:
Klimisch 4
Additional information

For the developmental toxicity/teratogenicity of diisotridecyl adipate, no study could be located. Information on developmental toxicity, available for di-2-ethylhexyl adipate as supporting substance, is use for read across.

 

Developmental toxicity of di-2-ethylhexyl adipate was investigated in a prenatal developmental toxicity study according to OECD TG 414 (Cefic, 1988). In this study, a developmental NOAEL of 170 mg/kg bw/day was determined.

Di-2-ethyhexyl adipate is a saturated branched chain aliphatic adipate diester and closely related to diisotridecyl adipate. It is used as supporting substances for read across as justified in more detail in the attached read-across document.

 

Justification for classification or non-classification

The available developmental and one-generation reproduction toxicity data do not warrant classification for developmental toxicity according to EU regulation (Directive 67/548/EEC and Regulation (EC) No. 1272/2008).