Oligo

Endpoint summary

Key value for chemical safety assessment

Effects on fertility

Description of key information

Oral (OECD 421, read across), 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:

rat

Effect level:

50 000 ppm

Based on:

test mat.

Sex:

male/female

Remarks on result:

other: equivalent to 6000 mg/kg bw/day

Key result

Critical effects observed:

no

Key result

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

50 000 ppm

Based on:

test mat.

Sex:

male/female

Remarks on result:

other: equivalent to 6000 mg/kg bw/day

Key result

Critical effects observed:

no

Key result

Reproductive effects observed:

no

Conclusions:

The read across approach is justified in the analogue justification. The target and source substances are considered unlikely to differ in their reproduction toxicity potential. The toxicity of the target substance is estimated based on an adequate and reliable reproduction/developmental toxicity screening test with the structural analogue source substance Fatty acids C16-18 (even numbered), mono, di and triesters with sucrose (no CAS). In a study conducted according to OECD guideline 421 in male and female rats with the source substance Fatty acids C16-18 (even numbered), mono, di and triesters with sucrose (no CAS) the NOAEL was found to be 50000 ppm in diet, corresponding to 6000 mg/kg/day (highest dose tested) based on the absence of adverse effects on parental fertility and based on absence of adverse effect on the development of F1 offspring up to the age of 13 days. Therefore, a NOAEL of 6000 mg/kg bw is considered for the target substance Fatty acids C16-18(even numbered), oligoesters with sucrose (no CAS) for fertility and developmental toxicity.

Effect on fertility: 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 adequate and reliable (Klimisch score 1) studies 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, eco-toxicological and toxicological profile. 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 fertility: via inhalation route

Endpoint conclusion:

no study available

Effect on fertility: via dermal route

Endpoint conclusion:

no study available

Additional information

Read across justification

There are no data on the repeated dose toxicity of Fatty acids C16-18(even numbered), oligoesters with sucrose (no CAS). The assessment was therefore based on a study 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).

The reproductive/developmental toxicity of the analogue source substance Fatty acids C16-18 (even numbered), mono, di and triesters with sucrose (no CAS) was determined in an OECD Guideline 421 test. Groups of 10 male and 10 female rats were fed diets with 0, 10000, 30000, or 50000 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 50000 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

Oral (OECD 421, read across), 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 adequate and reliable (Klimisch score 1) studies 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, eco-toxicological and toxicological profile. 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

Read across justification

There are no data on the repeated dose toxicity of Fatty acids C16-18(even numbered), oligoesters with sucrose (no CAS). The assessment was therefore based on a study 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).

The reproductive/developmental toxicity of the analogue source substance Fatty acids C16-18 (even numbered), mono, di and triesters with sucrose (no CAS) was determined in an OECD Guideline 421 test. Groups of 10 male and 10 female rats were fed diets with 0, 10000, 30000, or 50000 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 observed up to the age of 13 days and 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 50000 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), oligoesters with sucrose (no CAS), data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

Therefore, based on the read-across approach no toxicity to reproduction and development are expected for Fatty acids C16 -18 (even numbered), oligoesters 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.