Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Description of key information

In accordance with Regulation (EC) No 1907/2006, Annex VIII, 8.7.1 column 2, no test for reproductive toxicity is required as pre-natal developmental toxicity studies are available and included in the technical dossier.

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

Justification for selection of Effect on fertility via oral route:
In accordance with Regulation (EC) No 1907/2006, Annex VIII, Section 8.7.1 Column 2, no screening study for reproductive toxicity is required as data on pre-natal developmental toxicity are available and included in the technical dossier.

Effects on developmental toxicity

Description of key information
Oral (OECD 414), rat: 
NOAEL, developmental toxicity: ≥ 1000 mg/kg bw/day
NOAEL, maternal toxicity: ≥ 1000 mg/kg bw/day
Effect on developmental toxicity: via oral route
Endpoint conclusion:
no adverse effect observed
Quality of whole database:
The available information comprises adequate and reliable studies (Klimisch score 2) from reference substances with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products and similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details). The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.7, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Effect on developmental toxicity: via inhalation route
Endpoint conclusion:
no study available
Effect on developmental toxicity: via dermal route
Endpoint conclusion:
no study available
Additional information

Developmental toxicity

There are no substance-specific data available in regard to developmental toxicity for Decyl 2-Ethylhexanoate (CAS 93777-46-9). To fulfil the standard data requirements defined in Regulation (EC) No 1907/2006, Annex VIII, 8.7, read-across from appropriate substances is conducted in accordance with Regulation (EC) No 1907/2006, Annex XI, 1.5.

According to Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met”. In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across) “to avoid the need to test every substance for every endpoint”.

 

For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substances are the basis of read-across. A detailed justification for the analogue read- across approach is provided in the technical dossier (see IUCLID Section 13).

As no reliable measured/experimental data are available on developmental toxicity of Decyl 2-Ethylhexanoate (CAS 93777-46-9), read-across to reliable data on the analogue substance Fatty acids, C16-18, 2-ethylhexyl esters (CAS 91031-48-0) and 2-Ethylhexyl stearate (CAS 22047-49-0) was conducted.

CAS 91031-48-0

A prenatal developmental toxicity study was performed with Fatty Acids, C16-18, 2-ethylhexyl esters (CAS 91031-48-0) according to OECD Guideline 414 (Pittermann, 1994). Groups of 24 female Sprague-Dawley rats received daily oral gavage doses of the test substance in arachidis oil at dose levels of 0, 100, 300 and 1000 mg/kg bw/day during gestational days 6 to 15. On day 20 of gestation the animals were euthanized and examined for maternal and fetal parameters. Based on the number of implantations, number of total litter losses by resorption, mortality, clinical signs, body weight, and gross pathology and organ weights of maternal animals the NOAEL for maternal toxicity was found to be 1000 mg/kg bw/day. Examination of fetus litter size and weights, offspring viability (number alive and number dead), sex ratio, grossly visible abnormalities, external, head, soft tissue and skeletal abnormalities showed no differences to control and no indication for teratogenic effects. Therefore, the NOAEL for embryo-/fetotoxicity and teratogenicity in rats for Fatty acids C16-18, 2-ethylhexyl esters was found to be 1000 mg/kg bw/day.

 

CAS22047-49-0

The developmental toxicity of 2-Ethylhexyl stearate (CAS 22047-49-0) was investigated according to OECD Guideline 414 and GLP conditions (Aulmann, 2000). Groups of 24 female Sprague-Dawley rats received daily oral gavage doses of the test substance in arachidis oil at dose levels of 0, 100, 300 and 1000 mg/kg bw/d during gestational days 6 to 15. On day 20 of gestation the animals were euthanized and examined for maternal and fetal parameters. Based on the number of implantations, number of total litter losses by resorption, mortality, clinical signs, body weight, gross pathology and organ weights of maternal animals the NOAEL for maternal toxicity was found to be 1000 mg/kg bw/d. Examination of fetus litter size and weights, offspring viability (number alive and number dead), sex ratio, grossly visible abnormalities, external, head, soft tissue and skeletal abnormalities showed no differences to control and no indication for teratogenic effects. Therefore, the NOAEL for embryo-/fetotoxicity and teratogenicity in rats for 2-Ethylhexyl stearate was found to be 1000 mg/kg bw/day.

Conclusion on developmental toxicity

The available data show that two structural analogue substances did not affect organogenesis or fetal development in utero. Thus, Decyl 2-Ethylhexanoate (CAS 93777-46-9) is not considered to exhibit developmental toxicity.

Justification for classification or non-classification

Based on the analogue read-across approach, the available data on developmental toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008, and is therefore conclusive but not sufficient for classification in regard to developmental toxicity. However, as no data for reproductive toxicity is included in the dossier in accordance with Regulation (EC) No 1907/2006, Annex VIII, Section 8.7.1 Column 2, no conclusive decision on reproductive toxicity is possible

according to Regulation (EC) 1272/2008.