Registration Dossier
Registration Dossier
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reaction mass of: pentasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}naphthalene-2,7-disulfonate;tetrasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;tetrasodium 4-amino-5-hydroxy-6-[(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-3-[(E)-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(2-hydroxyethylsulfonyl)-phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate;trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[-2-sulfonato-4-(2-hydroxyethylsulfonyl)phenylazo]naphthalene-2,7-disulfonate
EC number: 445-280-9 | CAS number: 371921-40-3
Endpoint summary
Administrative data
Description of key information
Not skin irritant
Irreversible effects on the eye
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irreversible damage)
Additional information
Skin irritation/corrosion
The primary skin irritation potential of the test article was investigated by topical application of 0.5 g to 6 cm2 intact dorsal skin of each of three young adult New Zealand White rabbits according to the OECD guideline 404.
The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. The scores of each animal at the following reading times (24, 48, 72 hours) were used in calculating the respective mean values for each type of lesion.
The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing by the number of data points. The primary irritation score was 0.00 (max. 8.0).
Local signs (mean values from 24 to 72 hours) consisted of grade 0.00 erythema and grade 0.00 edema. No signs of irritation were observed.
The test article caused light blue staining of the treated skin.
No corrosive effects were noted on the treated skin of any animal at any measuring interval.
Eye irritation/corrosion
The primary irritation potential of the test article was investigated by instillation of 0.1 g into one eye of each of three young adult New Zealand White rabbits according to the OECD guideline 405. The treated eyes were not rinsed after application. Scoring of irritation effects was performed approximately 1, 24, 48 and 72 hours as well as 7, 14 and 21 days after test article application. The scores of each animal at the following reading times (24, 48 and 72 hours) were used in calculating the respective mean values for each type of lesion.
The primary irritation score was calculated by totalling the individual cumulative scores at 24, 48 and 72 hours and then dividing the resulting total by the number of data points. The primary irritation score was 0.00 (max. 13). No signs of irritation were observed.
Blue staining of the nictitating membrane and the sclera by the test article was observed in all animals. Scleral staining persisted in two animals until 14 days after treatment and in one animal until 21 days. Light staining of the nictitating membrane was evident in all animals until the end of the observation period.
No corrosion was observed at any of the measuring intervals.
Justification for classification or non-classification
No effects such as erythema and oedema were observed on the skin of the three rabbits assessed in the skin irritation study. According to the CLP Regulation n.1272/2008 the substance is therefore not classified as skin irritant.
Blue staining of the nictitating membrane and the sclera by the test article was observed insetad in all animals treated according to the OECD 405. Scleral staining persisted in two animals until 14 days after treatment and in one animal until 21 days. Light Staining of the nictitating membrane was evident in all animals until the end of the observation period. According to the CLP Regulation n. 1272/2008, Table 3.3.1, a substance is allocated in Category 1 if:"in at least one animal effects on the cornea, iris or conjunctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days". Due to the irreversible effects observed in the study available, the substance is classified as "Seroius eye damage" Category 1.
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