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
Skin irritation / corrosion = irritant
Eye irritation = eye damaging
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Skin irritation/Skin Corrosion
A publication related to Basci Green 1 is available ans show some effects on skin.
Clemmensen et al. (1984) tested the skin irritation of similar substances. A 20 % (200 mg/ml) suspension did not produce visible erythema or oedema on either rats or guinea pigs, therefore rabbit skin irritation study was not performed.
In the Dystar (1982) study, conducted following OECD guidelines, after the sample administrations the skin of the rabbit resulted coloured in green and oedema was not easily identifiable; dehydration-atrophy of the skin and no repairs activities within 8 days were noted, nevertheless it is reasonable to assume that the effect is reversible in 14 days.
All the results show some effects on skin and based on this, Basic Green 1 sould be considered as skin irritant.
Eye irritation
A preliminary consideration has to be made: 1% solution (10 mg/ml) of similar substance in water has a pH of 1.4. Due to this low pH (< 3.0), the chemical is like to be a corrosive.
In a case it is reported that 1% solution of similar substance 05 resulted in destructive keratinis with hypopyon (hypopyon is pus in the eye; it is a leukocyte exudate, seen in the anterior chamber, usually accompanied by redness of the conjunctiva) and terminated in bilateral blindness due to corneal opacification (Grant, 1974). In the same book, similar substance 05
is reported to cause injury ranging in severity from conjunctiva oedema, hyperemia, purulent discharge to total opacification of corneal stroma (Grant, 1974., p. 431).Clemmensen et al. (1984) tested eye irritation for Similar Substance 03. Instillation of 8 % aqueous solution produced market oedema, substantial discharge and slight hyperemia of the conjunctiva, which disappeared after 24 h in two out of three rabbits. Treatment with fine crystals of similar substance 04 produced a totally opaque corneas, bright red and oedematous conjunctivae up to four days.
Trans-corneal penetration studies revealed lack of detectable concentration of the tested substance in the aqueous humour and showed that it is unlikely to cause intraocular toxicity (Velpandian, 2007). Furthermore in vitro tissue retention studies revealed that increasing the contact time increases tissue concentration of the substance (Velpandian, 2007).
In conclusion, all studies confirm that similar substances cause severe eye irritation and based on this considerations, Basic Green 1 sulphate is considered to be a sever eye irritant.
Justification for selection of skin irritation / corrosion endpoint:
Most reliable data
Justification for selection of eye irritation endpoint:
Most reliable data
Effects on skin irritation/corrosion: irritating
Effects on eye irritation: highly irritating
Justification for classification or non-classification
According to CLP regulation (EC1272/2008) Basic Green 1 is classified as Eye Dam 1, H318 (Causes serious eye damage).
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