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Administrative data

Description of key information

The substance was found to be corrosive in an in vitro study employing the Human Skin Model Test with EpiDerm™ tissues model. After exposure to the substance the relative absorbance value decreased to 89.6% after 3 minutes exposure. After 1 hour exposure the relative absorbance value was reduced to 3.9%. The viability after 60 min exposure exceeded the threshold for corrosivity which is defined to be 50% after the 3 minutes exposure and 15% after the 1 hour exposure. The substance was found to be an irritant in an in vitro study employing the Human Skin Model Test. Compared to the relative absorbance value of the negative control the mean relative absorbance value decreased to 3.8% after exposure of the skin tissues to the substance. This value is below the threshold for irritancy of ≤ 50%. Therefore, the substance is considered to possess an irritant potential.

An in vitro study was performed to assess the corneal damage potential of the substance employing the BCOP assay using fresh bovine corneae. Relative to the negative control, the substance caused a distinct increase of the corneal opacity. The calculated mean IVIS was 72.95 (threshold for seriouseye damage: IVIS ≥ 55). According to OECD 437 the substance is classified as serious eye damaging.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin corrosion: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
20 September 2016 - 07 October 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Reconstructed Human Epidermis (RHE) Test Method)
Version / remarks:
Updated Guideline adopted July 29, 2016
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
- Batch No.of test material: 20140124
- Storage condition of test material: At room temperature
- 25 µL of deionised water and 25 mg (39.7 mg/cm2) of the test item were applied onto the surface of duplicate EpiDermTM tissue and spread to match the surface.

Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Vehicle:
water
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
25 µL of deionised water and 25 mg (39.7 mg/cm2) of the test item were applied onto the surface of duplicate EpiDermTM tissue and spread to match the surface.
Duration of treatment / exposure:
Test Item: 3 ± 0.5 minutes, 60 ± 5 minutes
Negative Control: 3 ± 0.5 minutes, 60 ± 5 minutes
Positive Control: 3 ± 0.5 minutes, 60 ± 5 minutes
Duration of post-treatment incubation (if applicable):
3 hours
Number of replicates:
Duplicate tissues
Irritation / corrosion parameter:
% tissue viability
Remarks:
% of negative control
Run / experiment:
3 minutes
Value:
89.6
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Remarks:
% of negative control
Run / experiment:
60 minutes
Value:
3.9
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid
Other effects / acceptance of results:
Exposure to the positive control induced a decrease in the relative absorbance as compared to the negative control, both for the 3 minutes exposure period (29.5%) and for the 1 hour exposure period (6.2%) thus confirming the validity of the test system and the specific batch of tissue models.
Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
The substance is considered to be corrosive to skin since the viability after 3 minutes exposure is greater than 50% (89.6%) and the viability after 1 hour exposure decreased below 15% (3.9%).

Executive summary:

An in vitro study was performed to assess the corrosive potential of the substance employing the Human Skin Model Test with EpiDerm™ tissues model. The substance passed the MTT- and the Colour Interference pre-tests. Independent duplicate tissues of EpiDermTMwere exposed to the substance, the negative control (deionised water) or the positive control (8.0 N KOH) for 3 minutes and 1 hour, respectively. The required acceptability criteria were met. After exposure to the substance the relative absorbance value decreased to 89.6% after 3 minutes exposure. After 1 hour exposure the relative absorbance value was reduced to 3.9%. The viability after 60 min exposure exceeded the threshold for corrosivity which is defined to be 50% after the 3 minutes exposure and 15% after the 1 hour exposure. Therefore, the test item is considered to be corrosive to the skin.

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
20 September 2016 - 10 October 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
Original Guideline adopted July 28, 2015
Deviations:
no
GLP compliance:
yes
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Vehicle:
unchanged (no vehicle)
Remarks:
Surface wetted with Dulbecco's Phosphate Buffered Saline
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
25 mg (approximately 39 mg/cm2 according to guideline) of test item to tissues, wetted with 25 µL DPBS.
Controls: 30 µL.
Duration of treatment / exposure:
60 minutes.
Duration of post-treatment incubation (if applicable):
42 hours
Number of replicates:
Triplicate.
Irritation / corrosion parameter:
% tissue viability
Value:
3.8
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Other effects / acceptance of results:
The acceptance criteria were met:
• The mean OD570 of the negative control tissues was ≥ 0.8 and ≤ 2.8 (values between 1.781 and 2.036).
• The mean relative tissue viability of the positive control was ≤ 20% (4.8%).
• The rel. SD of 3 identical replicates was < 18% values between 7.4 and 17.1).

 Dose Group  Relative Absorbance (%)  Relative Standard Deviation (%)  Mean  Relative Absorbance (% of negative control)
 Negative Control  96.5  7.4  100
   108.6    
   94.9    
 Positive Control  5.6  14.1  4.8
   4.6    
   4.3    
 Substance  4.6  17.1  3.8
   3.5    
   3.4    
Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
In conclusion, it can be stated that the substance is an irritant to skin according to UN GHS and EU CLP regulation.
Executive summary:

An in vitro study was performed to assess the irritation potential of the substance employing the Human Skin Model Test. Compared to the relative absorbance value of the negative control the mean relative absorbance value decreased to 3.8% after exposure of the skin tissues to the substance. This value is below the threshold for irritancy of ≤ 50%. Therefore, the substance is considered to possess an irritant potential.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
23 September 2016 - 23 September 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Version / remarks:
July, 2013
Deviations:
no
GLP compliance:
yes
Specific details on test material used for the study:
Batch number: 20140124
Storage Conditions: At room temperature
Species:
cattle
Details on test animals or tissues and environmental conditions:
Freshly isolated bovine cornea (at least 9 month old donor cattle)
Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
yes, concurrent positive control
Amount / concentration applied:
20% solution (w/v) in saline
Duration of treatment / exposure:
240 minutes
Number of animals or in vitro replicates:
Three
Irritation parameter:
in vitro irritation score
Value:
72.95
Vehicle controls validity:
valid
Negative controls validity:
not examined
Positive controls validity:
valid
Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
The calculated mean IVIS for the substance was 72.95 (threshold for serious eye damage: IVIS ≥ 55). According to OECD 437 the test item is classified as serious eye damaging.
Executive summary:

An in vitro study was performed to assess the corneal damage potential of the substance by means of the BCOP assay using fresh bovine corneae. With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed (mean IVIS= 1.17). The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity effects on the corneae (mean IVIS =106.19) corresponding to a classification as serious eye damaging (CLP/EPA/GHS (Cat 1)). Relative to the negative control, the substance caused a distinct increase of the corneal opacity. The calculated mean IVIS was 72.95 (threshold for serious eye damage: IVIS ≥ 55). According to OECD 437 the substance is classified as serious eye damaging.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irreversible damage)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

Based on the findings of reliable in vitro corrosion and irritation studies conducted on the substance, the substance meets the requirement for classification as a skin corrosive.

Based on the findings of a reliable in vitro eye toxicity study conducted on the substance, the substance meets the requirement for classification as seriously damaging to the eye.