Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 303-161-8 | CAS number: 94158-87-9
Determination of the primary non-irritant concentration
No signs of irritation occurred after application of the different test concentrations.
Treatment of the animals with Freund's Adjuvant can lower the threshold value for primary irritation determined in preliminary tests. For this reason, the five animals in the escort group which had been treated with Freund's Adjuvant were treated with 25 % Remazol-Brillantgelb 4GL in isotonic saline. As no reactions were observed in these animals, a concentration of 25% Remazol-Brillantgelb 4GL in isotonic saline was chosen for the challenge at day 22.
Tolerance of intradermal injections
The intradermal injections with the 0.2 % and 1.0 % preparations caused very slight erythema and barely perceptible oedema. Very slight to well-defined erythema and very slight to slight oedema occurred after application of the 5 % preparation.
Based on this preliminary test, a 5 % preparation was selected for the intradermal injections in the main test.
Main test for sensitising properties
Body weight gains and clinical signs
The treated animals showed no clinical signs of intoxication throughout the study.
The intradermal injections with Freund's Adjuvant (with and without test substance) caused severe erythema and oedema as well as indurated, encrusted and scabbed skin. The application sites treated with the test substance in the vehicle exhibited slight erythema and oedema. Intradermal applications of the vehicle caused no signs of irritation. Additionally the application sites treated with the test substance in Freund's Adjuvant showed yellowish discolorations.
After the removal of the patch at day 10, erythema and oedema, scabbed and encrusted skin as well as necrosis and open wounds were observed at the sites previously treated with Freund's Adjuvant. The injection sites treated with the test substance in the vehicle and the vehicle alone showed no signs of irritation.
Additionally yellow discolored skin was noted in the animals of the treatment group.
The body weight gains of the treated animals were not impaired.
No signs of irritation were observed 24 and 48 hours after removal of the occlusive bandage in the control group. 48 hours after removal of the occlusive bandage three animals of the treated group showed very slight erythema.
After the repeated dermal challenge treatment the animals of the control group showed no signs of irritation. 48 hours after removal of the occlusive bandage very slight up to moderate erythema were noted at the skin of seven animals of the treated group. Additionally, very slight oedema as well as dry, rough and encrusted skin were observed.
Body weight gains
Body weight at start of study
Body weight at end of study
Scoring of dermal reactions – individual data
Challenge treatment, escort group
Remazol-Brillantgelb 4GL 25% in isotonic saline (day 15)
Treated area: left flank
Scoring of dermal reactions
48 hours p.a.
Light yellow discoloured
72 hours p.a.
Challenge treatment: Remazol-Brillantgelb 4GL 25% in isotonic saline (day 22)
Time of observation: 48 hours after treatment (day 24)
Light yellow discol.
Time of observation: 72 hours after treatment (day 24)
Repeated challenge treatment: Remazol-Brillantgelb 4GL 25% in isotonic saline (day 29)
Time of observation: 48 hours after treatment (day 31)
Time of observation: 72 hours after treatment (day 32)
The skin of seven treated animals showed a positive reaction during the observation period after the challenge.
Testing for sensitizing properties of Remazol-Brillantgelb 4GL was performed in female Guinea pigs according to the method of MAGNUSSON & KLIGMAN .
Intradermal induction was performed using 5.0 % Remazol -Brillantgelb 4GL in isotonic saline. Dermal induction and challenge treatment were carried out with 25% Remazol-Brillantgelb 4GL in isotonic saline.
Based on the results of this study Remazol-Brillantgelb 4GL may cause sensitisation by skin contact.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Close Do not show this message again