Tetrasodium 4,4'-bis[[4-[bis(2-hydroxypropyl)amino]-6-[(4-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-stilbene-2,2'-disulphonate

Endpoint summary

Description of key information

Category assessment:
Human sensitisation data: not sensitising and not sensitising under light exposure

Additional information

CAS 16090 -02 -1:

Human sensitisation data: Griffith (1973) published data of a human repeated insult patch test (HRIPT) on 70 volunteers. A 0.5 % aqueous solution of a detergent mixture containing 10 % of CAS 16090-02 -1 was applied under occlusive patches in a series of 9 applications, each of 24 hours duration, during a 3-week period. Challenge applications were made two weeks later. No positive skin reactions were observed and therefore of CAS 16090 -02 -1 was considered not to be a skin sensitizer.

In a short summary, Maibach (1971) reported a repeated insult patch test on 102 volunteers. of CAS 16090 -02 -1 was dissolved in petrolatum to concentrations of 1 % and 5 % and was applied for a total of 10 applications (3 per week) under occlusive dressing for 48 hours (72 hours on the weekend). This was followed by a rest period and final elicitation on a fresh application site. There was no evidence of allergenic skin contact sensitization at both concentrations tested.

A photosensitization study with of CAS 16090 -02 -1 on 78 human volunteers is described in the same publication as given above (Griffith (1973). Using the repeated insult patch test procedure, a 0.35 % aqueous solution of a detergent containing 24 % of of CAS 16090 -02 -1and also two other fluorescence whitening agents was applied under occlusive patches in a series of 9 applications, each of 24 hours duration, during a 3-week period. On two days of each week, immediately after removal of the patches, test areas were exposed to outdoor sunlight for 30 minutes. Challenge applications were made two weeks later. No positive skin reactions were observed and therefore of CAS 16090 -02 -1 was considered not to be a skin sensitizer under the test conditions employed.

 

CAS 13863 -31 -5:

There were two patch test studies done on human volunteers and published 1973 (Griffith 1973). In the first test the test material (a 0.5% aqueous solution of a detergent mixture containing 10% of the test substance) was applied under occlusive patches in a series of 9 applications (each of 24 hours duration) during a 3 week period to 65 human subjects. Challenge applications were made two weeks later. The vehicle also was applied as a negative control. No positive control was applied. The detergent base contained sodium alkylbenzene sulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate and minor ingredients including perfumes. Component concentrations were not listed, but were stated as being within ranges of usual commercial formulations. The test application sites were graded for primary irritation at various intervals (times were not stated). No positive reactions were observed.

In the second study 78 human volunteers were tested. The test material, a 0.35% aqueous solution of a detergent mixture containing 16% of the test substance was applied under occlusive patches in a series of 9 applications, each of 24 hours duration, during a three-week period. In a first series, the detergent mixture contained sodium alkylbenzenesulfonate, sodium alkylsulfate, sodium tripolyphosphate, sodium sulfate, and minor ingredients including perfumes, in the second series the detergent contained 32% sodium perboraten. Two days of each week, immediately after removal of the patches, the test areas were exposed for 30 minutes to available outdoor sunlight (the tests were done during the period of march through may.). Challenge applications were made two weeks later. A vehicle without test substance was applied as negative control. No positive controls (i.e., known sensitizers) were used, in order to avoid sensitizing people unnecessarily. The test application sites were graded for primary irritation at intervals during the insult patching sequence. In all 78 volunteers the results were negative.

 

CAS 17958-73-5:

Also pulished by Griffith (1973), CAS 17958 -73 -5 was applied under occlusive patches in a series of 9 applications (each of 24 hours duration) during a 3 week period. 73 human subjects received a detergent solution with 10% test item and 66 human subjects one with with 1% test item. Challenge applications were made two weeks later. The vehicle also was applied as a negative control. No positive control was applied. The detergent base contained sodium alkylbenzenesulfonate, sodium alkyl sulfate, sodium tripolyphosphate, sodium sulfate and minor ingredients including perfumes. Component concentrations were not listed, but were stated as being within ranges of usual commercial formulations. The test application sites were graded for primary irritation at various intervals (times were not stated). No indication of sensitization reaction was observed.

 

CAS 4193-55-9:

A short summary of a study on the sensitising potential in humans is available (Ciba 1980). A repeated insult patch test with fifty human volunteers receiving applications for 24 h every third day for 3 weeks was done. After a two week rest period challenge applications were made in the same manner. Scoring were performed 48 hours after application. None of the subjects reacted to any of the primary applications or to the challenge. The documentation is insufficient to allow assessment of reliability of the study.

CAS 27344-06-5:

A repeated insult patch test with fifty human volunteers receiving applications of a commercial formulation containing 2% of CAS 27344 -06 -5 for 24 h every third day for 3 weeks was done (Clariant 2001). After a two week rest period challenge applications were made in the same manner. Scoring were performed 48 hours after application. None of the subjects reacted to any of the primary applications or to the challenge. The study is described in sufficient detail to conclude on validity and reliability.

All these tests consistently yielded negative results indicating that commercial formulations containing stilbene fluorescent whitening agents have no sensitising potential to humans. It is concluded that these negative findings can also be transferred to the stilbenes which were not tested.