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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

According to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Item 8.7.1, Column 2, a screening study for reproductive / developmental toxicity does not need to be conducted if either a pre-natal developmental toxicity study or an extended one-generation reproductive toxicity study is available. Thus, in accordance with the information provided in Column 2, no reproductive toxicity data are required for the target substance neopentyl glycol dicaprate (CAS 27841-06-1) as a pre-natal developmental toxicity study is available for the analogue source substance decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6). Based on read-across, these data are considered for the assessment of reproductive and developmental toxicity of the target substance.

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
Additional information

There are no studies available for the target substance neopentyl glycol dicaprate (CAS 27841-06-1) assessing its potential to induce effects on reproduction.

Suitable data was read across from a source substance. A short-term (28-day) oral repeated dose toxicity study with the source substance fatty acids, C7-8, triesters with trimethylolpropane (CAS 189120-64-7) was performed according to OECD guideline 407 and under GLP conditions (Exxon, 2000). Groups of five male and five female Cr:CD BR rats were exposed to the substance at 100, 300 and 1000 mg/kg bw/day by gavage, 7 days/week for 28 days. The only systemic effect observed was an increased amount of hyaline droplets (the main constituent of which is alpha-2µ-globulin) in the proximal cortical tubular epithelium in male rats treated with 300 and 1000 mg/kg bw/day. This effect is widely accepted to be specific to the male rat and as such is considered to have no relevance to the human. With special regard to reproductive tissues (ovaries, epididymides, prostate, testes and uterus), the examination of organ weights as well as gross pathology and histopathology showed no substance-related findings. Based on the absence of effects up to the highest dose tested, the NOAEL was found to be 1000 mg/kg bw/day.

The available data do not indicate any effect related to reproductive toxicity for the source substance. Therefore, no hazard for toxicity to reproduction is expected for the target substance.

Effects on developmental toxicity

Description of key information

Pre-natal developmental toxicity: dermal (read-across, equivalent/similar to OECD 414): NOAEL (systemic, rat, m/f) = 2000 mg/kg bw/day; NOAEL (development, rat) = 2000 mg/kg bw/day

Link to relevant study records
Reference
Endpoint:
developmental toxicity
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
refer to analogue justification provided in IUCLID section 13
Reason / purpose for cross-reference:
read-across source
Key result
Dose descriptor:
NOAEL
Remarks:
systemic
Effect level:
2 000 mg/kg bw/day (nominal)
Based on:
test mat.
Basis for effect level:
other: maternal toxicity
Remarks on result:
other: Source: CAS 11138-60-6, Azuka and Daston, 2004
Key result
Dose descriptor:
NOAEL
Remarks:
local
Effect level:
200 mg/kg bw/day (actual dose received)
Based on:
test mat.
Basis for effect level:
other: maternal toxicity
Key result
Dose descriptor:
NOAEL
Remarks:
development
Effect level:
2 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
other: no effects observed
Remarks on result:
other: Source: CAS 11138-60-6, Azuka and Daston, 2004
Key result
Abnormalities:
no effects observed
Key result
Developmental effects observed:
no
Conclusions:
No potential for developmental toxicity was observed in a study performed with a source substance. As explained in the analogue justification, this result is considered to be valid also for the target substance.
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
Species:
rat
Quality of whole database:
The available information comprises an adequate and reliable (Klimisch score 2) study from a source substance with similar structure and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological profiles. The selected study is thus sufficient to fulfil the standard information requirements set out in Annexes VIII - X, Item 8.7, in accordance with Annex XI, Item 1.5, of Regulation (EC) No. 1907/2006 (REACH).
Additional information

No data regarding developmental toxicity / teratogenicity for the target substance neopentyl glycol dicaprate (CAS 27841-06-1) are available. Therefore, the developmental toxicity / teratogenicity endpoint was assessed based on data from the analogue source substance decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6).

Decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6) was tested in a pre-natal developmental toxicity study equivalent or similar to OECD guideline 414 (Azuka and Daston, 2004). The GLP status was not specified. The test substance was percutaneously applied to Sprague-Dawley rats for 6 h/day under occlusive conditions. 25 animals per sex per dose were treated with 200, 600 or 2000 mg/kg bw/day in corn oil on Days 6 - 15 of gestation. Control animals (25 per sex per dose) received the vehicle. The middle and the high dose levels caused some local irritation at the site of application, but no decreases in maternal weight gain or food consumption. There were no differences from control in any of the developmental parameters measured, including embryo/fetal viability, fetal weight, malformations, or variations. Therefore, a NOAEL of 2000 mg/kg bw/day was derived for pre-natal development and for systemic maternal toxicity. Due to the irritation effects on skin, the local maternal NOAEL was found to be 200 mg/kg bw/day.

The available data do not indicate a developmental toxicity / teratogenic potential after dermal application for the source substance. Therefore, no hazard for developmental toxicity / teratogenicity is expected for the target substance.

Justification for classification or non-classification

The available data on developmental toxicity and teratogenicity of the analogue source substance decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6) do not meet the classification criteria according to the CLP Regulation (EC) No. 1272/2008. Based on read-across, also no classification is warranted for the target substance neopentyl glycol dicaprate (CAS 27841-06-1). Data are, therefore, conclusive but not sufficient for classification.

Additional information