Erythritol

Endpoint summary

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2011

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Remarks:

Clinical test performed for cosmetic regulation n°1223/2009 compliance (efficacy claim support) relevant for REACH compliance

Justification for type of information:

Frequently performed cosmetic efficacy assay with human exposure

Qualifier:

no guideline followed

Principles of method if other than guideline:

Prior to the start of the trials, the initial skin moisture of the test persons (female) was measured with the aid of a Corneometer® which detects the skins moisture retention in the superficial layers of the stratum corneum as deep as 10-20 μm (to be ensured that the measurement is not influenced by capillary blood vessels).
For two weeks, the human applied emulsions with different glycerin:ERYTHRITOL ratios (3:0; 2:1; 1:1; 1:2; 0:3) daily on their right forearm.
Four measure points per test person were determined: one measure point where the skin has not been treated with the emulsion and three measure points where the skin has been treated with the emulsion.

The main purpose of this study is to determine the ability of the substance to hydrate human skin, as part of a cosmetic test. The authors of the study the authors of the study also evaluate the skin irritation potential of the substance. Given the animal model used (human) and the duration of the test (2 weeks), it can be considered reliable in assessing the potential for irritation of the skin by erythritol

GLP compliance:

not specified

Remarks:

Clinical test performed for cosmetic regulation n°1223/2009 compliance (efficacy claim support) relevant for REACH compliance

Specific details on test material used for the study:

different glycerin:Erythritol ratios (3:0; 2:1; 1:1; 1:2; 0:3) then between 25% and 75%

Species:

other: human

Details on test animals or test system and environmental conditions:

healthy female test persons of different age and different skin type

Type of coverage:

open

Preparation of test site:

not specified

Vehicle:

other: glycerin

Controls:

yes, concurrent vehicle

yes, concurrent negative control

Amount / concentration applied:

0%, 33%, 50%, 66%, 100%

Duration of treatment / exposure:

daily, for 2 weeks on their right forearm

Number of animals:

10 persons per glycerin:Erythritol ratios (3:0; 2:1; 1:1; 1:2; 0:3)

Details on study design:

For statistical reasons four measure points per test person were determined: one measure point where the skin has not been treated with the emulsion and three measure points where the skin has been treated with the emulsion.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

14 d

Score:

ca. 0

Max. score:

0

Reversibility:

not specified

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

People who are sensitive or allergic to certain chemical components can have skin irritation, rashes or other allergic reactions when getting in contact with certain substances. None of the 80 test persons having Erythritol on their skin reported any side effect, even those with dry or sensitive skin had no skin irritations during or after the testing period.

Other effects:

moisturizing effect

Interpretation of results:

GHS criteria not met

Conclusions:

Erythritol has proven to have a very good skin compatibility and can be considered as non-irritant.

Executive summary:

In a clinical test in 80 humans, Erythritol has proven to have a very good skin compatibility and can be considered as non-irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

(Q)SAR

Adequacy of study:

supporting study

Study period:

13/03/2018-14/03/2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model and falling into its applicability domain, with limited documentation / justification

Justification for type of information:

1. SOFTWARE and MODEL (incl. version number) : Danish QSAR Database, is able to predict the Severe Skin irritation in Rabbit using a battery of three QSAR prediction models - SciQSAR, LeadScope and CASE Ultra.

2. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL :
OCC(O)C(O)CO

3. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL

- Defined endpoint: skin irritation. Even if the endpoints of skin and eye irritation/corrosion are not dependent on each other, the result for skin does hints about the irritation/corrosion potential of the same substance for eye. A positive result for skin irritation may hint (but not always) about a possible irritation effect on the eye. Possibility for the three models to determine the Severe Skin irritation in Rabbit.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Danish QSAR Database, is able to predict the Severe Skin irritation in Rabbit using a battery of three QSAR prediction models - SciQSAR, LeadScope and CASE Ultra. Even if the endpoints of skin and eye irritation/corrosion are not dependent on each other, the result for skin does hints about the irritation/corrosion potential of the same substance for eye. A positive result for skin irritation may hint (but not always) about a possible irritation effect on the eye

GLP compliance:

not specified

Specific details on test material used for the study:

OCC(O)C(O)CO

Irritation parameter:

other:

Remarks on result:

no indication of irritation

Remarks:

QSAR predicted results

Other effects / acceptance of results:

Not specified

Interpretation of results:

GHS criteria not met

Conclusions:

Erythritol was predicted as non-irritant to the skin. The results were just reported to add further weight to the results derived for eye irritation on this substance using OECD QSAR ISafeRabbit Eye irritation HA-QSAR.

Executive summary:

Based  on  all  the QSAR models  incoroporated  into  Danish QSAR  Database,  the  query chemical was predicted as non-irritant to the skin. The results were just reported to add further weight to the results derived for eye irritation on this substance using OECD QSAR ISafeRabbit Eye irritation HA-QSAR.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

(Q)SAR

Adequacy of study:

key study

Study period:

13/03/2018-14/03/2018

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

results derived from a valid (Q)SAR model, but not (completely) falling into its applicability domain, with adequate and reliable documentation / justification

Justification for type of information:

1. SOFTWARE

2. MODEL (incl. version number) : iSafeRabbit Eye Irritation High Accuracy-QSAR (HA-QSAR) v1.1.

3. SMILES OR OTHER IDENTIFIERS USED AS INPUT FOR THE MODEL : OCC(O)C(O)CO

4. SCIENTIFIC VALIDITY OF THE (Q)SAR MODEL
- Defined endpoint: Eye Irritation/Corrosion potential
- Unambiguous algorithm:
- Defined domain of applicability:
- Appropriate measures of goodness-of-fit and robustness and predictivity:
- Mechanistic interpretation:
- Experimental validation : QSAR) model v1.1 validated for the chemical group in question, i.e. polyols (alcohols). The QSAR is based on validated data for a current training set of 295 chemicals derived from eye irritation/corrosion studies on rabbits.

5. APPLICABILITY DOMAIN
- Descriptor domain: The test substance 1,2,3,4-Butanetetrol is within applicability domain of the iSafeRabbit® eye irritation/corrosion prediction model, with the exception of the the descriptor domain of water solubility. However, the solubility of 3.63 ×107 mg/L, is in close proximity of the maximum WS value of the domain range (2.4 × 107) which means the prediction may considered as an extrapolation.
- Structural fragment domain : 1,2,3,4-Butanetetrol is a four carbon alcohol of the type polyol, which is inside the structural fragment domain of iSafeRabbit® eye prediction model.
- Mechanistic domains: N/A
- Statistics : The statistical validation of the iSafeRabbit® eye irritation/corrosion prediction model was evaluated by quantifying the number of substances for which the output of the eye irritation model corresponds to a correct prediction, based on the fully validated in-vivo eye irritation result for each substance. This number of correct predictions is then divided by the total number of substances in the training set for the relevant chemical group, i.e. alcohols and given as a number and as a percentage. This percentage is 80% of correct predictions

6. ADEQUACY OF THE RESULT
QSAR model adapted specifically to test guideline: OECD 405, EU B.4. then result can be interpreted in term of eye irritation potential

Qualifier:

equivalent or similar to guideline

Guideline:

other: REACH Guidance on QSARs R.6

Version / remarks:

QSAR following OECD 405

GLP compliance:

not specified

Specific details on test material used for the study:

OCC(O)C(O)CO

Irritation parameter:

other: cell body burden and cytoxicity

Run / experiment:

NA

Vehicle controls validity:

not applicable

Negative controls validity:

not applicable

Positive controls validity:

not applicable

Remarks on result:

no indication of irritation

Remarks:

QSAR predicted results

Other effects / acceptance of results:

Not specified

Interpretation of results:

GHS criteria not met

Conclusions:

The erythritol is reliably predicted as non-irritant to the eye

Executive summary:

The erythritol was reliably predicted as non-irritant to the eye with iSafeRabbit HA-QSAR v1.1 for Eye Irritation/Corrosion, model adapted specifically to test guideline: OECD 405, EU B.4.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)