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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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:
key study
Study period:
January 2018 - March 2018
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:
2016
GLP compliance:
yes
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
skin obtained from plastic surgery from multiple donors
Source strain:
other: 09-KERA-007 + 09-KERA-010
Control samples:
yes, concurrent negative control
yes, concurrent positive control
yes, concurrent MTT non-specific colour control
Amount/concentration applied:
20 mg/tissue
Duration of treatment / exposure:
3, 60 , 240 min
Number of replicates:
3
Irritation / corrosion parameter:
% tissue viability
Value:
ca. 80.46
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: no corrosive
Interpretation of results:
GHS criteria not met
Conclusions:
Since, the tissue viability is 80.46 % after the 240-minute exposure, the test item Cysteamine Hydrochloride is predicted to be non-corrosive under the experimental conditions described .
Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
February 2018- March 2018
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:
OECD, 2015
GLP compliance:
yes
Test system:
human skin model
Source species:
human
Cell type:
non-transformed keratinocytes
Cell source:
skin obtained from plastic surgery from multiple donors
Source strain:
other: 09-KERA-007 + 09-KERA-010
Control samples:
yes, concurrent negative control
yes, concurrent positive control
yes, concurrent MTT non-specific colour control
Amount/concentration applied:
10 mg/tissue
Duration of treatment / exposure:
15 minutes
Duration of post-treatment incubation (if applicable):
42h
Number of replicates:
3
Irritation / corrosion parameter:
% tissue viability
Value:
ca. 80.65
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Interpretation of results:
GHS criteria not met
Conclusions:
The mean relative tissue viability for the test item, Cysteamine Hydrochloride was 80.65 % and hence, it is predicted to be non-irritant under the experimental conditions described.
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
Study period:
01/02/2018-28/02/2018
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:
OECD, 2017
GLP compliance:
yes
Specific details on test material used for the study:
The test system used in this study is Reconstructed Human Cornea-like Epithelium (RhCE).
RhCE cell construct is a nonkeratinized epithelium composed of normal human keratinocytes in a three-dimensional structure. It mimics the corneal epithelium with progressively stratified but not cornified cells.
Species:
human
Strain:
other: KERATINOCYTES - 4F1188
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
Sufficient amount of test item to cover the entire tissue surface.
Duration of treatment / exposure:
5 hours and 58 minutes.
Duration of post- treatment incubation (in vitro):
18 hours.
Number of animals or in vitro replicates:
2
Irritation parameter:
other: tissue viability
Value:
ca. 3.23
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive indication of irritation
Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
Under the test method and test conditions employed the tissues treated with test item cisteamine hydrochloride showed a relative percent viability < 60 % hence, it is concluded that the test item cisteamine hydrochloride was Irritant (I).
Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for classification or non-classification