Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
170 mg/kg bw/day
Additional information

For the test item Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is no study available. However, it is likely that the studies conducted on the read-across substance bis (2 -ethylhexyl) adipate are valid for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol (please see justification 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:
For the test item Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is no study available. However, it is likely that the studies conducted on the read-across substance bis (2 -ethylhexyl) adipate are valid for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol (please see justification 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
For the test item Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is no study available. However, it is likely that the studies conducted on the read-across substance bis (2 -ethylhexyl) adipate are valid for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol (please see justification 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
Dose descriptor:
NOAEL
170 mg/kg bw/day
Additional information

For the test item Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol is no study available. However, it is likely that the studies conducted on the read-across substance bis (2 -ethylhexyl) adipate are valid for Reaction product of adipic acid and sebacic acid and isotridecan-1 -ol (please see justification 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.

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).