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Diss Factsheets

Administrative data

Description of key information

Skin corrosion and irritation was tested in vitro in studies according to GLP and OECD TG 431 and 439, respectively. No corrosive or irritation property of the test compound was observed, these data are in agreement with early and limited documented studies in rabbits and humans in which cotton patch tests did not indicate irritation properties to the skin. Overall, no skin irritation property is anticipated.

Eye irritation was tested in an in vitro human corneal epithelial cell (HCE) test according to GLP. No irritation property was observed. In an early, limited and only shortly reported in vivo test in rabbits only very slight and transient effects were observed. Overall, it is concluded that the compound has no eye irritation properties.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: guideline study according to GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
other: in vitro
Strain:
other: reconstructed human epidermis (RHS) model EST-1000
Type of coverage:
other: in vitro
Preparation of test site:
other: in vitro
Vehicle:
unchanged (no vehicle)
Controls:
other: The results of the concurrent negative control (NC, 0.9% NaCI) and positive control (PC, 5% SDS) demonstrated the viability (NC) and sensitivity (PC) of the test model.
Duration of treatment / exposure:
Undiluted N-Phenyi-N-[(trichloromethyl)thio]benzenesulphonamide was applied topically to the RHS model, i.e. 30 mg per insert (plus 30 µl 0.9%NaCI to moisten and ensure good contact with the skin; three replicates).
Observation period:
After an exposure period of 20 minutes, followed by a 42 hours post-treatment incubation period, the cell viability was measured to be 102 % (rounded) in the MTT (Methylthiazoletetrazolium) conversion assay.
Number of animals:
not applicable; triplicates
Irritation / corrosion parameter:
other: % cell viability
Run / experiment:
Cell viability [%]
Value:
102.38
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Non-Irritant

After an exposure period of 20 minutes, followed by a 42 hours post-treatment incubation period, the cell viability was measured to be 102 % (rounded) in the MTT (Methylthiazoletetrazolium) conversion assay.

The results of the concurrent negative control (NC, 0.9% NaCI) and positive control (PC, 5% SDS) demonstrated the viability (NC) and sensitivity (PC) of the test model.

Thus, the results show that no skin irritant property of N-Phenyi-N[( trichloromethyl)thio]benzenesulphonamide was determined by the assay used.

Interpretation of results:
GHS criteria not met
Executive summary:

Thus, the results show that no skin irritant property of N-Phenyl-N[( trichloromethyl)thio]benzenesulphonamide was determined by the assay used.

Endpoint:
skin corrosion: in vitro / ex vivo
Remarks:
in vitro
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study according to GLP
Qualifier:
according to guideline
Guideline:
OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Species:
other: in vitro
Strain:
other: The experiment was carried out on a reconstructed human epidermis EST-1000 (CeiiSystems, St. Katharinen, Germany)
Type of coverage:
other:
Preparation of test site:
other:
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
A 100% concentration was tested on the skin/epidermal equivalents in triplets. For the determination of time related cytotoxic effects the incubation periods were 3 min. and 60 min., respectively.
Observation period:
3 min. and 60 min.
Number of animals:
in vitro;n triplicates
Irritation / corrosion parameter:
other: % cell viability
Run / experiment:
Cell viability after 3 min. [%]
Value:
107
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Non-Corrosive
Irritation / corrosion parameter:
other: % cell viability
Run / experiment:
Cell viability after 60 min. [%]
Value:
100.91
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Non-Corrosive

The MTT (Methylthiazoletetrazolium) method has determined the following values of viability after 3 min. or after 60 min. of incubation: 107% and 101% (rounded), respectively. Thus, the results show that no corrosive property of the test item was

determined by the assay used.

Interpretation of results:
GHS criteria not met
Conclusions:
Thus, the results show that no corrosive property of the test item was determined by the assay used.
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:
2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: study according to GLP
Principles of method if other than guideline:
The HCE model is currently involved in the eye irritation validation conducted by the COLIPA following ECVAM guidelines. This study is expected to end late this year and results published early 2012. The HCE is produced and commercialized by SkinEthic since 2000- more than 11 years-, and is the only model made from human corneal cells. The model is routinely used by the major Cosmetic and Pharmaceutical companies, and has already been prevalidated in 2004 (4). Furthermore, this model is recognized as the model of choice and scientifically relevant as documented by several publications (5, 6, 7). These tests are also related to OECD 405, Attachment March 2000.

The purpose of this protocol is to evaluate the potential ocular irritation of the test substance by measuring cell viability in the human corneal epithelial cell (HCE) construct, available from SkinEthic Laboratories, following topical exposure to the test substance via MTT [3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide] dye conversion.
GLP compliance:
yes (incl. QA statement)
Species:
other: in vitro
Strain:
other: human corneal epithelial cell (HCE)
Vehicle:
unchanged (no vehicle)
Controls:
other: The results of the concurrent negative (NC, PBS) and positive control (PC, 1 H-1 ,2,4-Triazole-3-thiol) demonstrated the viability (NC) and sensitivity (PC) of the test model.
Duration of treatment / exposure:
After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 93% (rounded) as measured by a MTT conversion assay.
Observation period (in vivo):
After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 93% (rounded) as measured by a MTT conversion assay.
Number of animals or in vitro replicates:
in vitro; triplicates
Irritation parameter:
other: % cell viability
Run / experiment:
Cell viability [%]
Value:
93.17
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: Non-Irritant

After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 93% (rounded) as measured by a MTT conversion assay.

The results of the concurrent negative (NC, PBS) and positive control (PC, 1 H-1 ,2,4-Triazole-3-thiol) demonstrated the viability (NC) and sensitivity (PC) of the

test model.

The results show that N-Phenyi-N-[(trichloromethyl)thio]benzenesulphonamide is predicted as non-irritant under the conditions of this test method.

Interpretation of results:
GHS criteria not met
Executive summary:

The results show that N-Phenyl-N-[(trichloromethyl)thio]benzenesulphonamide is predicted as non-irritant under the conditions of this test method.

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

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Most reliable study; additional weight-of-evidence studies are discussed in the key information.

Justification for selection of eye irritation endpoint:
Most reliable study; an additional in vivo study is discussed on a weight of evidence base in the key information.

Justification for classification or non-classification

No skin or eye irritation properties are anticipated based on reliable in vitro data and limited in vivo data.