Registration Dossier
Registration Dossier
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EC number: 211-190-1 | CAS number: 633-03-4
Endpoint summary
Administrative data
Description of key information
Potential sensitisation effects of the test substance to human skin were described in several studies and one case report.
Based on the effects showed in all the studies, Basic Green 1 might be considered sensitizing in humans prone to allergic skin reactions.
Additional information
Several studies were published and examined in a weight of evidence approach with the results from exposure of human skin:
1) Bielicky T. and Novak M. (1969) applied the test substance to skin of patients previously found to be reactive toward triphenylmethane. The test substance was applied in a concentration of 2 % in water. A positive reaction was detected in 11 out of 11 patients.
2) A case report by Shehade S.A. and Foulds I.S. (1986) described a patient that developed eczema after treatment with a gel containing the test substance. After determination of the treatment healing was observed. A following patch test revealed a positive reaction to a concentration of 0.5 and 2 % of the test substance in water on the patient’s skin.
3) Björnberg A. and Mobacken H. (1972) performed a single dose treatment on healthy back skin of humans. A concentration of 1 % test substance induced no alterations. In addition the forearm skin was stripped and the test substance was applied two times. Here it induced painful superficial ulcerations. Healing of the necrotic tissue occurred after 2-3 weeks leaving hyperpigmentation and scars.
4) Manzini et al. (1991) established with 20 healthy volunteers that the test substance (concentration of 2 % pet.) was non-irritant on skin. 569 patients that presented with a dermatitis considered to be allergic in origin were patch tested with the same concentration of the test substance. The test was performed on healthy skin on the back of the patients. Two days after application the test substance was removed and the skin area was examined the next day. A positive reaction of the skin was found in only 2 out of 569 patients.
The review from Hatch K.L. and Maibach H.I. (1995) stated that the test substance was found to belong to a group of dyes that induces allergic contact dermatitis in patients. It was found to be an allergen discovered in patients using patch tests.
Conclusion
All the available information revealed a possible development of contact dermatitis in humans after exposure to the test substance.
In addition, all the available studies of dyes of the same family showed sensitizing effects and based on the above considerations, Basic Green 1 is to be considered as skin sensitizer.
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