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Diss Factsheets

Administrative data

Description of key information

The registered substance is UN GHS Skin Irritation Category 2.

The registered substance is UN GHS Eye Irritation Category 2.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records
Reference
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study Initiation date: 18 May 18 Study conclusion date: 24 Sep 18
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:
2015
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Test Item name: Agent 447C
Purity: 40% Active in water, ~90% purity of active material
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
other: All cells used are purchased or derived from tissue obtained by MatTek Corporation from accredited institutions
Justification for test system used:
Recommended test system in international guidelines (OECD)
Vehicle:
unchanged (no vehicle)
Details on test system:
Reconstructed Human Epidermis (RHE) tissue
- MatTek EpiDerm Tissue model EPI-200, Lot # 28614
-Keratinocyte Strain 00267
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
TEST MATERIAL
- amount applied: 30μI
-
Duration of treatment / exposure:
60 ± 1 minutes (25 minutes at room temperature and 35 minutes at 37°C, 5% CO2, ≥95% RH)
Duration of post-treatment incubation (if applicable):
42 ± 4 hours post-treatment incubation
Number of replicates:
3
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
1
Value:
2.589
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:
Other effects:
Colour interference with MTT: no
Interpretation of results:
study cannot be used for classification
Conclusions:
The test determined that a 40% solution of the registered substance reduced the viability to below 50% and is therefore an "irritant" according to OECD 439. OECD 439 cannot resolve between UN GHS Categories 1 and 2, further information on skin corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the skin. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the irritant result with OECD 439, the registered substance is a Skin Irritant Category 2.
Executive summary:

The skin irritation potential of Agent 447C (a 40% solution of the registered substance) was assessed in vitro according to OECD 439. After 60 ± 1 minute exposure on the surface of the EpiDerm reconstructed human epidermis, and a 42 ± 4-hours post-exposure incubation time, viability of the tissues was assessed and compared to the negative control. The percentage of viability obtained was 2.589% and therefore Agent 447C (a 40% solution of the registered substance) was classified as irritant to the skin.

 

As OECD 439 cannot resolve between UN GHS Categories 1 and 2, further information on skin corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the skin. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the irritant result with OECD 439, the registered substance is a Skin Irritant Category 2.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

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:
Study Initiation date: 04 April 18 Study conclusion date: 17 May 18
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
Version / remarks:
2017
GLP compliance:
yes (incl. QA statement)
Specific details on test material used for the study:
Test Item name: Agent 447C
Purity- 40% Active in Water, ~90% purity of active material
Species:
human
Details on test animals or tissues and environmental conditions:
TEST ITEM:
EpiOcular™ (OCL-200) Reconstructed Human Ocular Epithelium
Lot # 27036
Keratinocyte Strain 4F1188
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
20 μI of PBS (sterile Dulbecco's Phosphate Buffered Saline) + 50 μI of test item
Duration of treatment / exposure:
30 minutes ± 2 minutes
Duration of post- treatment incubation (in vitro):
2 hours ± 15 minutes
Number of animals or in vitro replicates:
3
Details on study design:
Details of materials, reagents and equipment used are recorded in the study data.
Positive control -Methyl Acetate
Negative control - Sterile Water (tissue grade)
Irritation parameter:
cornea opacity score
Run / experiment:
Mean
Value:
0.061
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Irritation parameter:
in vitro irritation score
Remarks:
Mean of viability
Value:
2.838
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid

Prior to the study, the required preliminary test confirmed that the test item did not interfere with MTT or solvent.

% of viability: 2.838 - Classification = No prediction.

Interpretation of results:
study cannot be used for classification
Conclusions:
The test determined that a 40% solution of the registered substance reduced the viability to below 60% and therefore “no prediction” regarding the irritation or corrosive potential of the substance can be determined according to OECD 492. OECD 492 cannot resolve between UN GHS Categories 1 and 2, further information on eye corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the eye. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the irritant result with OECD 492, the registered substance is a Eye Irritant Category 2.
Executive summary:

The eye irritation potential of Agent 447C (a 40% solution of the registered substance) was assessed in vitro according to OECD 492. After 30 ± 2 minutes exposure on the surface of the EpiOcular reconstructed ocular epithelium, and a 2 hour ± 15 minutes post-incubation time, viability of the tissues was assessed and compared to the negative control. The percentage of viability obtained was 2.838% and no prediction can be made for Agent 447C (a 40% solution of the registered substance) as further information is required to distinguish between corrosive and irritating.

 

In vitro testing with OECD 492 has not allowed for a prediction of eye irritation of Agent 447C (a 40% solution of the registered substance). As OECD 492 cannot resolve between UN GHS Categories 1 and 2, further information on eye corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the eye. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the “no prediction” result with OECD 492, the registered substance is a Eye Irritant Category 2.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

The skin irritation potential of Agent 447C (a 40% solution of the registered substance) was assessed in vitro according to OECD 439. After 60 ± 1 minute exposure on the surface of the EpiDerm reconstructed human epidermis, and a 42 ± 4-hours post-exposure incubation time, viability of the tissues was assessed and compared to the negative control. The percentage of viability obtained was 2.589% and therefore Agent 447C (a 40% solution of the registered substance) was classified as irritant to the skin.

 

As OECD 439 cannot resolve between UN GHS Categories 1 and 2, further information on skin corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the skin. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the irritant result with OECD 439, the registered substance is a Skin Irritant Category 2.

The eye irritation potential of Agent 447C (a 40% solution of the registered substance) was assessed in vitro according to OECD 492. After 30 ± 2 minutes exposure on the surface of the EpiOcular reconstructed ocular epithelium, and a 2 hour ± 15 minutes post-incubation time, viability of the tissues was assessed and compared to the negative control. The percentage of viability obtained was 2.838% and no prediction can be made for Agent 447C (a 40% solution of the registered substance) as further information is required to distinguish between corrosive and irritating.

 

In vitro testing with OECD 492 has not allowed for a prediction of eye irritation of Agent 447C (a 40% solution of the registered substance). As OECD 492 cannot resolve between UN GHS Categories 1 and 2, further information on eye corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the eye. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the “no prediction” result with OECD 492, the registered substance is a Eye Irritant Category 2.

Justification for classification or non-classification

In vitro testing with OECD 439 and 492 has identified Agent 447C (a 40% solution of the registered substance) as irritant to the skin and eye; respectively. As OECD 439 and 492 cannot resolve between UN GHS Categories 1 and 2, further information on skin and eye corrosion is required. Experience during manufacturing and use indicate that the registered product is not corrosive to the skin or eye. Therefore, based on a weight of evidence with the consideration of the lack of corrosive effects during manufacture and use combined with the irritant result with OECD 439 and 492, the registered substance is a Skin Irritant Category 2 and Eye Irritant Category 2.