Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Key value for chemical safety assessment

Toxic effect type:
concentration-driven

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Additional information

The test was waived based on no effects on fertility in an OECD 422 study with read across substance Hatcol 3346, EC# 230 -743 -8 and no adverse effects on reproductive organs or tissues observed during the repeated dose toxicity studies of the read across substances.



Short description of key information:
Conclusions for reproduction toxicity of Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid (EC# 270-470-1) are based on read across from analogue substances of an existing category (pentaerythritol and dipentaerythritol esters), in particular EC#230-743-8. As data from available repeated dose toxicity studies (read across) indicate no adverse effects on reproductive organs or tissues, a 2-generation reproductive toxicity study (as required in section 8.7.3.) does not need to be conducted. Additionally, exposure of this substance to humans is expected to be limited.

Effects on developmental toxicity

Description of key information
Conclusions for developmental toxicity of Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid (EC# 270-470-1) (Hatcol 1106) are based on read across from analogue substances of an existing category (pentaerythritol and dipentaerythritol esters), in particular EC#230-743-8.
In view of the structural similarity, physicochemical properties and data available the NOAEL for developmental toxicity is ≥1000 mg/kg bw/d.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Study duration:
subchronic
Species:
rat
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Additional information

Based on read across from a structurally related substance, a NOAEL for developmental toxicity of1000 mg/kg bw/d was derived. The NOAEL of the read across substance (Hatcol 3346, EC# 230 -743 -8) was determined based on results of an OECD 422 test. In the absence of any effects on the pups development including external and visceral examination at necropsy, no further testing for developmental toxicity is warranted.

Justification for classification or non-classification

Based on these above considerations, the substance does not need to be classified for reproductive toxicity according tothe Dangerous Substance Directive 67/548/EC and CLP Regulation(EC) 1272/2008.

Additional information