Fatty acids C16-18 (even numbered), mono and di esters with Sucrose

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

In the absence of data on toxicity to reproduction (fertility) for the target substance Fatty acids C16 -18 (even numbered), mono and diesters with sucrose (no CAS) read-across approach was conducted on source substance Fatty acids C16 -18 (even numbered), mono, di and tristers with sucrose (no CAS) as explained in the analogue justification (chapter 13):

Oral (OECD 421), rat: NOAEL fertility = 50000 ppm (equivalent to 6000 mg/kg bw/day based on a conversion factor for rats by EFSA)

Link to relevant study records

Reference

Endpoint:

screening for reproductive / 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:

fertility

Effect level:

50 000 ppm

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: No adverse effects observed up to the highest dose of 50,000 ppm (equivalent to 6000 mg/kg bw/day based on a conversion factor of 0.12 for rats by EFSA).

Remarks on result:

other: Source: MDT, Desai, 2017, OECD 421

Key result

Critical effects observed:

no

Key result

Dose descriptor:

NOAEL

Remarks:

development

Generation:

F1

Effect level:

50 000 ppm

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: No adverse effects observed up to the highest dose of 50,000 ppm (equivalent to 6000 mg/kg bw/day based on a conversion factor of 0.12 for rats by EFSA).

Remarks on result:

other: Source: MDT, Desai, 2017, OECD 421

Key result

Critical effects observed:

no

Key result

Reproductive effects observed:

no

Conclusions:

In an OECD TG 421 study available from source substance Fatty acids C16 -18 (even numbered), mono, di and triesters with sucrose (no CAS) the NOAEL for parental fertility and developmental toxicity of the offspring was 50,000 ppm (equivalent to 6000 mg/kg bw/day based on a conversion factor for rats by EFSA). Therefore and by analogy, the target substance is expected to be 6000 mg/kg bw/day for parental fertility and developmental toxicity.

Effect on fertility: via oral route

Endpoint conclusion:

adverse effect observed

Dose descriptor:

NOAEL

6 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

The available information comprises an adequate and reliable study from a source substance with similar structure and intrinsic properties. Read-across is justified based on common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, ecotoxicological and toxicological profile (refer to endpoint discussion for further details). This study is thus sufficient to fulfill the standard information requirements set out in Annex VIII, 8.7, of Regulation (EC) No 1907/2006.

Effect on fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

Data on the toxicity to reproduction of Fatty acids, C16-18 (even numbered), mono and diesters with sucrose (no CAS) are not available. The assessment was therefore based on studies conducted with an analogue substance as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. 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 substance 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).

Reproductive toxicity

Fatty acids, C16-18 (even numbered), mono di and triesters with sucrose

The reproductive/developmental toxicity of the test substance was determined in an OECD Guideline 421 test. Groups of 10 male and 10 female rats were fed diets with 0, 10,000, 30,000, or 50,000 ppm of the test substance in the diet for 14 days prior to mating and during mating. The females continued to be fed the test substance through gestation and lactation. The resulting litters were examined for viability and mortality. No treatment related adverse effects from the test substance were seen in any parental animal. The NOAEL for the test substance for reproductive toxicity was 50,000 ppm (equivalent to 6000 mg/kg bw/day based on a conversion factor for rats according to the "Guidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data" (EFSA, 2012)).

Reference:

EFSA (2012) Guidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data. EFSA Journal, 10 (3), 2579.

Effects on developmental toxicity

Description of key information

In the absence of data on developmental toxicity for the target substance Fatty acids C16 -18 (even numbered), mono and diesters with sucrose (no CAS) read-across approach was conducted on source substance Fatty acids C16 -18 (even numbered), mono, di and tristers with sucrose (no CAS) as explained in the analogue justification (chapter 13):

Oral (OECD 421), rat: NOAEL development = 50000 ppm (equivalent to 6000 mg/kg bw/day based on a conversion factor for rats by EFSA)

Effect on developmental toxicity: via oral route

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

NOAEL

6 000 mg/kg bw/day

Study duration:

subacute

Species:

rat

Quality of whole database:

The available information comprises an adequate and reliable study from a source substance with similar structure and intrinsic properties. Read-across is justified based on common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, ecotoxicological and toxicological profile (refer to endpoint discussion for further details). This study is thus sufficient to fulfill the standard information requirements set out in Annex VIII, 8.7, 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

Fatty acids, C16-18 (even numbered), mono di and triesters with sucrose

The reproductive/developmental toxicity of the test substance was determined in an OECD Guideline 421 test. Groups of 10 male and 10 female rats were fed diets with 0, 10,000, 30,000, or 50,000 ppm of the test substance in the diet for 14 days prior to mating and during mating. The females continued to be fed the test substance through gestation and lactation. The resulting litters were examined for viability and mortality. No treatment related adverse effects were seen in the offspring. Therefore, the NOAEL for developmental toxicity was considered to be 50,000 ppm (equivalent to 6000 mg/kg bw/day based on a conversion factor for rats by EFSA, 2012).

Reference:

EFSA (2012) Guidance on selected default values to be used by the EFSA Scientific Committee, Scientific Panels and Units in the absence of actual measured data. EFSA Journal, 10 (3), 2579.

Justification for classification or non-classification

 According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that "substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Fatty acids, C16-18 (even numbered), mono and diesters with sucrose, data will be generated from data available for reference source substance to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

Based on the analogue read-across approach, the available data on reproductive/developmental toxicity do not meet the classification criteria according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.

Therefore, based on the read-across approach no toxicity to reproduction and development are expected for Fatty acids, C16-18 (even numbered), mono and diesters with sucrose (no CAS). However, no final decision on classification for reproductive toxicity according to Regulation (EC) 1272/2008 can be made, as only information from a screening study is available.