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EC number: 202-442-1 | CAS number: 95-70-5
Table 1: Scores forhemorrhage, vessel lysis, and coagulation after test substance exposure for 180 sec (study # 69835)
Table 2: Scores forhemorrhage, vessel lysis, and coagulation after reference substance (5%) exposure for 30 sec (study # 69835)
2 -methyl-p-phenylenediamine sulphate was tested for its acute eye irritation potential on the choriollantoic membrane (CAM) of fertilized chicken eggs.
Fresh, intact fertilized eggs of White Leghorn chicken were incubated for 9 d at temperature of 37.6±1°C and 40 -60% relative humidity. After a 9 d incubation period all eggs were checked with a candling lamp. Only eggs with a well developed embryonic vascular system were taken for the study. During candling the airspace outlined at the blunt end of the eggs was marked. The eggs were opened along the marked line with an electric drill. Then the white egg membrane was moistened with a few milliliters of physiological saline. If necessary the opened eggs were placed under a thermal lamp, in order to prevent cooling, until the test substance was applied. Prior to the test application, the egg membrane had to be removed from the CAM.
The test material was applied for 180 sec at the following concentration in the preliminary and main study:
Preliminary study (conducted with two eggs): Undiluted (99.9%), 25% suspension in water (reddish brown suspension) and aqueous solution (<1% beige)
Main study (conducted with six eggs): Undiluted (99.9%)
The undiluted solid test substance was applied by the aid of a spatula, the diluted test substance was applied in a dose of 300 µL by the aid of a pipette which was sufficient to cover at least 25% of the membrane. Sodium magnesium laurymyristyl-6-ethoxy-sulfate (Texapon ASV 70) (0.5, 1 and 5%) was used as reference substance.
The following symptoms were observed for the evaluation of irritation effects on the CAM:
- Haemorrhage (bleeding out of capillaries)
- Coagulation (Protein denaturation inside and/or outside the blood vessels)
- Lysis (disintegration of blood vessels)
Treatment was terminated by washing of the CAM with physiological saline
The following classification scheme of irritating properties was defined for S-values:
Exposure time:30 seconds/S[sum of single value]
Irritating (R 36)
Severely irritating (R 41)
In a pre-experiment neither the undiluted solid test substance induced any reaction in the end-point assessment after 30 and 180 sec. exposure time, nor did a 25% suspension or the aqueous solution (<1% in water). Hemorrhage, vessel lysis and coagulation scores were 0 for each egg in the main test.
In order to compare the results and to minimize effects due to biological variation of the egg batches, an irritation index of the reference substance "Texapon ASV" was calculated [5% active substance, pH 7]. This concentration was classified as moderately irritating to rabbit's eyes in the in vivo Draize test.
The test substance results in comparison to the reference substance is as follows:.
End-Point Method [S]
5 % AS
Based on the results, undiluted 2 -methyl-p-phenylenediamine sulphate was categorized as ‘slightly irritating’, compared to the reference substance, “Texapon ASV” (5%), using the HET-CAM (Hen’s Egg Test – Chorioallantoic Membrane)method.
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