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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Studies performed under GLP conditions.

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
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)
GLP compliance:
yes (incl. QA statement)
Test system:
human skin model
Source species:
human
Vehicle:
unchanged (no vehicle)
Details on test system:
The test item was applied as supplied
Control samples:
yes, concurrent negative control
yes, concurrent positive control
Amount/concentration applied:
16 mg
Duration of treatment / exposure:
42 min
Duration of post-treatment incubation (if applicable):
42h
Number of replicates:
3
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Test item - Mean percent viability
Value:
89.1
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Test item - Run 1
Value:
100.4
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Test item - Run 2
Value:
89
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Test item - Run 3
Value:
78
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Negative control - Mean percent viability
Value:
100
Negative controls validity:
valid
Positive controls validity:
valid
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Positive control - Mean percent viability
Value:
1.8
Negative controls validity:
valid
Positive controls validity:
valid
Interpretation of results:
GHS criteria not met
Conclusions:
The skin irritation potential was tested according to OECD 439 guideline on reconstructed human epidermis. The mean percent viability of the treated tissues was 89.1%. In accordance with the regulation EC n°1272/2008, the test item has to be considered as non-irritant to skin. It corresponds to UN GHS No category.
Executive summary:

The skin irritation potential was tested according to OECD 439 guideline on reconstructed human epidermis. The mean percent viability of the treated tissues was 89.1%. In accordance with the regulation EC n°1272/2008, the test item has to be considered as non-irritant to skin. It corresponds to UN GHS No category.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not 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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes (incl. QA statement)
Species:
chicken
Strain:
not specified
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
30 mg of test item after being reduced in fine powder
Duration of treatment / exposure:
10 seconds
Observation period (in vivo):
Treated corneas were evaluated pretreatment and starting at 30, 75, 120, 180 and 240 min after post-treatment rinse.
Number of animals or in vitro replicates:
3
Irritation parameter:
cornea opacity score
Run / experiment:
Maximal mean
Value:
2
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: corresponding to ICE class III
Irritation parameter:
fluorescein retention score
Run / experiment:
Mean
Value:
3
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: correspondaing ti ICE class IV
Irritation parameter:
percent corneal swelling
Run / experiment:
Maximal mean
Value:
4
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: corresponding to ICE class I
Other effects / acceptance of results:
The combinaison of the three endpoints for the positive control was 3 x IV. Therefore, the positive control is classified as "corrosive / severe irritant", as expected.
The combinaison of the three endpoints for the negative control was 3 x I. Therefore, the positive control is classified as "No category", as expected.
Interpretation of results:
study cannot be used for classification
Conclusions:
The eye irritation potential of the test item was determined according to OECD 438 guideline on isolated chicken eye. The results obtained show that the combination of the three endpoints for the test item was 1 x IV, 1 x III, 1 x I. This combination leads to the category "No prediction can be made" as defined in the OCED guideline. Additional testing is required to establish a definitive classification.
Executive summary:

The eye irritation potential of the test item was determined according to OECD 438 guideline on isolated chicken eye. The results obtained show that the combination of the three endpoints for the test item was 1 x IV, 1 x III, 1 x I. This combination leads to the category "No prediction can be made" as defined in the OCED guideline. Additional testing is required to establish a definitive classification.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification

The skin irritation potential was tested according to OECD 439 guideline on reconstructed human epidermis. The mean percent viability of the treated tissues was 89.1%. In accordance with the regulation EC n°1272/2008, the test item has to be considered as non-irritant to skin. It corresponds to UN GHS No category.

The eye irritation potential of the test item was determined according to OECD 438 guideline on isolated chicken eye. The results obtained show that the combinaison of the three endpoints for the test item was 1 x IV, 1 x III, 1 x I. This combinaison lead to the category "No prediction can be made" as defined in the OCDE guideline. Additionnal testing is required to establish a definitive classification.