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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin sensitisation (OECD 406, GPMT): not classified (no positive reactions were observed), read across of structurally similar substance

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
The read-across hypothesis is based on structural similarity of target and source substance. Based on the available data, including physico-chemical properties and metabolism, the read-across strategy is additionally supported by a quite similar toxicological profile of source and target substance.
The respective data are summarised in the attached read across justification document.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
Source substance: 1,3,5-triazine-2,4,6-trithione, trisodium salt (CAS 17766-26-6)
Target substance: 1,3,5-triazine-2,4,6-trithione (= trithiocyanuric acid; CAS 638-16-4)
Further information can be found in the attached read-across justification.

3. ANALOGUE APPROACH JUSTIFICATION
The substances are structurally similar and are expected to show similar properties. Further information can be found in the attached read-across justification.

4. DATA MATRIX
Please refer to the data matrix included in the attached read-across justification document.
Reason / purpose for cross-reference:
read-across source
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
induction: 0.1 and 1%; challenge: 75 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no dermal responses
Remarks on result:
other: based on read-across of source chemical
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
induction: 0.1 and 1%; challenge: 75 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no dermal responses
Remarks on result:
other: based on read-across of source chemical
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
induction: 0%; challenge: 75 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no dermal responses
Remarks on result:
other: based on read-across of source chemical
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
induction: 0%; challenge: 75 %
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no dermal responses
Remarks on result:
other: based on read-across of source chemical
Group:
positive control
Remarks on result:
not measured/tested
Interpretation of results:
GHS criteria not met
Conclusions:
Based on structural similarities of the target and source substances as presented above and in more detail in the justification for read across, it can be concluded that the available data from the source substance TMT are also valid for the target substance TMT H3.
The available data on skin sensitisation do not meet the criteria for classification according to CLP Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Skin sensitisation study with source substance:

TMT was examined for its skin sensitisation potential in a Guinea Pig Maximisation test (GPMT) which was conducted under GLP according to OECD Guideline 406 adopted in 1981.

A pilot study was performed to evaluate irritating effects after intradermal and topical application. Concentrations of 0.1%, 1%, 3% and 5% of TMT 55 each in water and in a 1:1 mixture (v/v) FCA/water were used in the primary irritation screen. The highest concentration that did not produce ulceration and/or necrosis was determined to be 0.1% in water and 1% in a 1:1 mixture (v/v) FCA/water. Moreover concentrations of 9.5%, 19%, 38% and 75% in water were selected to determine the topical dermal irritation threshold concentration of TMT 55. No signs of irritation were evident for any of these concentrations after a 24 h exposure period.

Therefore, in the main study 20 Crl:(HA)BR VAF/Plus guinea pigs received an intradermal application of 0.1% test material in water and 1% test material in a 1:1 mixture (v/v) FCA/water for induction at day 0 of the experimental period. A control group with 20 animals were treated with water and adjuvance only. On day 7 occlusive patches with 75% of the test substance were applied on the same site of the test animals for 48 h for topical induction, the control group were treated with water only. On day 21 test and control animals were challenged with 75% test material by occluded patch for 24 h on the right flank. 24 h and 48 h after removing the patches, no dermal reactions were recorded. Thus it is concluded, that based on the results of this GPMT test TMT 55 is not skin sensitising.

As laid down in the read across justification, this negative result on skin sensitisation can be transferred to the target substance Taicros TMT.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

The available data on skin sensitisation of Taicros TMT do not meet the criteria for classification according to CLP Regulation (EC) No. 1272/2008, and are therefore conclusive but not sufficient for classification