Registration Dossier
Registration Dossier
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EC number: 700-136-7 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Skin irritation/corrosion rabbit:
Mean irritation score 24, 48 and 72 h for each of 3 animals: 0.3 for erythema, 0.0 for oedema
Conclusion: No labelling requirement regarding skin irritation/corrosion
Eye irritation, rabbit:
Mean irritation score 24, 48 and 72 h for each of 3 animals:
0.0 for corneal opacity; 0.0 for iris lesion; 0.3 to 0.7 for redness of conjunctivae; 0.0 to 0.3 for oedema of conjunctivae (chemosis);
Conclusion: No labelling requirement regarding eye irritation
Local lymph node assay, mouse (Endpoint study record "7.4.1 Skin sensitisation - KEY_429_2009_Notox_489787_LLNA_mouse):
Group Mean Stimulation Index (SI) = 1.0, 3.0, 7.9 and 3.9 at test substance concentrations of 0 % (vehicle control), 10 %, 25 %, and 50 %, respectively.
Conclusion: Classification and labelling as
"irritant (Xi)" and "may cause sensitisation by skin contact (R43)" [DIRECTIVE 67/548/EEC] and
“Category 1” (Warning: May cause an allergic skin reaction)" [REGULATION (EC) 1272/2008].
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:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
In the skin irritation study with three rabbits, the mean Draize scores derived from 24, 48 and 72 hours post patch removal were 0.3 for erythema and 0.0 for edema. All edema findings were completely reversible within 24 and all erythema findings within 48 hours after patch removal. In the eye irritation study with three rabbits, the overall mean eye irritation scores 24, 48 and 72 hours post test substance instillation were 0.55 for conjunctival redness, 0.22 for chemosis and 0.0 for both, corneal opacity and iridal irritation. The minor conjunctival irritation was completely reversible within 72 hours post test substance instillation. According to EU classification rules [DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008] these minor findings in the skin and eye irritation studies would not require any classification and labelling regarding skin and eye irritation. However, the positive sensitisation response elicited in a local lymph node assay* in mice in all treated groups necessitates classification and labelling as "irritant (Xi)" and "May cause sensitisation by skin contact (R43)” according to DIRECTIVE 67/548/EEC and as “Category 1” (Warning: May cause an allergic skin reaction) according to REGULATION (EC) 1272/2008.
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* Endpoint study record "7.4.1 Skin sensitisation - KEY_429_2009_Notox_489787_LLNA_mouse
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