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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Effects on fertility

Effect on fertility: via oral route
Endpoint conclusion:
no study available
Effect on fertility: via inhalation route
Endpoint conclusion:
no study available
Effect on fertility: via dermal route
Endpoint conclusion:
no study available

Effects on developmental toxicity

Description of key information

Developmental toxicity - dermal:

read-across with Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (Trimethylolpropane caprylate caproate; TMPCC), supporting study, dermal, Sprague-Dawley rats; NOAEL ≥ 2000 mg/kg bw/d (similar to OECD guideline 414, C. Azuka and G.P. Daston, 2004) 

In a guideline conform study the potential of the analogous test substance Trimethylolpropane caprylate caproate

to assess the developmental toxicity after dermal administration was carried out using Sprague-Dawley rats (Azuka and Daston, 2004).

The test substance was administered to female rats from GD 6 until GD 20 daily with a minimum 6 hour exposure period in the concentrations: 0, 200, 600 and 2000 mg/kg bw/d.

TMPCC produced some dermal irritation at the site of application over the course of the treatment period at the 600- and 2,000-mg/kg/day dose levels; however, there appeared to be no systemic effects: maternal weight gain was not affected at any time during the course of treatment.

All clinical observations other than local skin irritation were considered unrelated to treatment. The clinical observations were either associated with local irritation caused by wearing the collar or the collar preventing the rat from normal grooming.

The assessment of the developmental toxicity of TMPCC showed no differences across dosage groups up to 2,000 mg/kg/day for any Caesarean-sectioning or litter parameters measured. Application dosage did not cause gross external, soft tissue, or skeletal malformations or variations. The litter averages for corpora lutea, implantations, litter size, live and dead fetuses, early and late resorptions, percent resorbed conceptuses, fetal body weights (total, male and female), and percent live male fetuses were comparable among the four dosage groups and did not differ significantly. There were no dead fetuses, no dams with all conceptuses resorbed, and all placentae appeared normal.

TMPCC administered dermally to Sprague-Dawley rats daily during the period of organogenesis at dosages up to 2,000 mg/kg/day produced no developmental toxicity, making the NOAEL for TMPCC >= 2,000mg/kg/day by the dermal route.

Under the conditions of this, TMPCC

is considered not to be a developmental toxicant in rats.
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no study available
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
2 000 mg/kg bw/day
Study duration:
subacute
Species:
rat
Quality of whole database:
comparable to guideline study with acceptable restrictions

Justification for classification or non-classification

Based on the results, the classification of the test substance for developmental toxicity / teratogenicity under Regulation 1272/2008 is not warranted.

Additional information