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EC number: 439-210-6
CAS number: 554-62-1
Table1: INDIVIDUAL EYE IRRITATION SCORES
Fluor area (%): green staining (percentage of total corneal area) after
b: Remnants of the test substance in the eye
c: Outside of the eyelids were red and swollen
k: Grey/white discolouration of the nictitating membrane (sign of
l: Grey/white discolouration of the eyelid (sign of necrosis)
Table2. MEAN VALUE EYE IRRITATION SCORES
# Animal specifications (at start of study):
Acute eye irritation/corrosion of PHYTOSPHINGOSINE was investigated in
the rabbit according to OECD 405 and in compliance with GLP.
Single samples of approximately 36 mg of PHYTOSPHINGOSINE (a volume of
approximately 0.1 ml) were instilled into one eye of each of three
rabbits. Observations were made 1, 24 and 48 hours after instillation.
Application of the test substance resulted in severe adverse effects on
the cornea, iris and conjunctivae. Corneal injury was seen as opacity
(maximum grade 3) and epithelial damage (maximum 75% of the corneal
area). The corneal injury persisted until termination (at 48 hours after
instillation). Iridial irritation (grade 1) was observed in all animals
and persisted until termination. Irritation of the conjunctivae was seen
as redness, chemosis and discharge, which persisted until termination in
all animals. Based on the severity of the ocular lesions observed during
the study, the animals were sacrificed for ethical reasons immediately
after the 48 hours observation. In conclusion, phytosphingosine causes
serious and irreversible damage to eye (corrosive).
The study was considered reliable and adequate for hazard assessment of
Based on these results and according to the classification criteria set
out in the CLP Regulation, phytosphingosine is classified for Serious
eye damage, Category 1, H318 "Causes serious eye damage".
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