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Description of key information

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
Reference:
Composition 0
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
Test material information:
Composition 1
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 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

Referenceopen allclose all

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.
Reference:
Composition 0
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
Test material information:
Composition 1
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.

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
Reference:
Composition 0
Qualifier:
equivalent or similar to
Guideline:
other: REACH Guidance on QSARs R.6
Version / remarks:
QSAR following OECD 405
GLP compliance:
not specified
Test material information:
Composition 1
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 valid:
not applicable
Negative controls valid:
not applicable
Positive controls valid:
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)

Additional information

Justification for classification or non-classification