oligomeric Reaction products from Hydrogenation and Hydrolysation of Starch

Toxicity to reproduction

Administrative data

Endpoint:

screening for reproductive / developmental toxicity

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

May 2021

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Prediction from OECD QSAR Toolbox

Justification for type of information:

REPORTING FORMAT FOR THE CATEGORY APPROACH
[Please provide information for all of the points below addressing endpoint-specific elements that were not already covered by the overall category approach justification made available at the category level. Indicate if further information is included as attachment to the same record, or elsewhere in the dataset (insert links in 'Cross-reference' table)]

1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL)
The OECD QSAR Toolbox is designed to create categories of substances based on defined similarity criterions. The category consists of similar substances and experimental data for category members is available. Therefore a prediction for the target chemical is possible based on the experimental data of the source substances. For details, please refer to attached documentation.

2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL
[Summarise here based on available experimental data how these results verify that the read-across is justified]
The OECD QSAR Toolbox is designed to create categories of substances based on defined similarity criterions. Data is gathered from internationally recognised inventories and databases. For details, please refer to attached documentation.

1. SOFTWARE
OECD QSAR Toolbox
2. MODEL (incl. version number)
4.4.1
3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL
OC[C@H](O)[C@@H](O)[C@H](O[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O)[C@H](O)CO
4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
[[Explain how the model fulfils the OECD principles for (Q)SAR model validation. Consider attaching the QMRF and/or QPRF or providing a link]
- Defined endpoint: for this prediction, any studies on reproductive effects were considered. Therefore the defined endpoint is "reproductive toxicity"
- Unambiguous algorithm: the prediction is done based on categorising similar chemicals with known experimental data
- Defined domain of applicability: the category is build up around the target substance. Therefore the substance is within the domain of applicability
- Appropriate measures of goodness-of-fit and robustness and predictivity: given in reports
- Mechanistic interpretation: when effects are predicted, an analysis of the category members contributing to the prediction will be done and a mechanistic interpretation will be performed.

5. APPLICABILITY DOMAIN
[Explain how the substance falls within the applicability domain of the model]
The category build up with QSAR toolbox considers the structural, empirical and/or mechanistical (including metabolism) properties of the substance. Therefore the category which is used for predicition is unique to the substance and it can be concluded that the substance falls within the applicability domain.

6. ADEQUACY OF THE RESULT
[Explain how the prediction fits the purpose of classification and labelling and/or risk assessment]
No adverse effects for the substance are predicted. Therefore information are available to conclude on classification.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2021

Report date:

2021

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Prediction using OECD QSAR Toolbox.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

4-O-α-D-glucopyranosyl-D-glucitol

EC Number:

209-567-0

EC Name:

4-O-α-D-glucopyranosyl-D-glucitol

Cas Number:

585-88-6

Molecular formula:

C12H24O11

IUPAC Name:

(2S,3R,4R,5R)-4-[(2R,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxyhexane-1,2,3,5,6-pentol

Specific details on test material used for the study:

not applicable for in silico

Test animals

Species:

rat

Strain:

not specified

Details on species / strain selection:

experimental data from various studies using mainly rats is considered.

Sex:

not specified

Results and discussion

Results: P0 (first parental generation)

Effect levels (P0)

Key result

Dose descriptor:

NOAEL

Effect level:

3 130 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

not specified

Basis for effect level:

reproductive performance

Remarks on result:

other: predicted value

Results: F1 generation

Effect levels (F1)

Key result

Dose descriptor:

NOAEL

Generation:

F1

Effect level:

3 130 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

not specified

Basis for effect level:

other: any toxicological effects

Overall reproductive toxicity

Key result

Reproductive effects observed:

no

Lowest effective dose / conc.:

3 130 mg/kg bw/day (nominal)

Treatment related:

no

Applicant's summary and conclusion

Conclusions:

A NOAEL of 3130 mg/kg bw/day for Reproductive effects is predicted using OECD QSAR Toolbox.