Registration Dossier

Administrative data

Description of key information

In vitro skin and eye irritation studies (OECD 439 and 492, respectively) on the read-across substance show no irritation potential to the skin or eye. Therefore, the registered substance is considered not irritating or corrosive.

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
Read-across from the alternative salt form of the registered substance is justified in section 13.
Reason / purpose:
read-across source
Qualifier:
according to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Version / remarks:
28 July 2015
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)
Version / remarks:
Commission Regulation (EU) No 640/2012 of 6 July 2012
Deviations:
no
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Duration of treatment / exposure:
1 hour
Duration of post-treatment incubation (if applicable):
42 hours
Number of replicates:
3 (per independent experiment, 2 test runs)
Irritation / corrosion parameter:
% tissue viability
Run / experiment:
Mean value of 3 tissues
Value:
92.3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Remarks:
100 %
Positive controls validity:
valid
Remarks:
4 %
Remarks on result:
other: Result refers to 2nd run. Due to the high inter-tissue variability of the test substance (1st run), a 2nd test run was performed to clarify the result.
Interpretation of results:
GHS criteria not met
Conclusions:
The registered substance is considered not irritating to skin based on an in vitro skin irritation using the reconstructed human epidermis test method on the source substance.
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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
Read-across from the alternative salt form of the registered substance is justified in section 13.
Reason / purpose:
read-across source
Qualifier:
according to
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:
28 July 2015
Deviations:
no
Duration of treatment / exposure:
6 hours
Duration of post- treatment incubation (in vitro):
18 hours
Number of animals or in vitro replicates:
2
Irritation parameter:
other: tissue viability [%]
Run / experiment:
Mean value of tissue 1and tissue 2
Value:
68.2
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Remarks:
100 %
Positive controls validity:
valid
Remarks:
22.3 %
Interpretation of results:
GHS criteria not met
Conclusions:
The registered substance is regarded as non irritating to eyes based on an OECD 492 study on the read-across substance.
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 CLP classification criteria are not met for skin or eye irritation or corrosion.