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EC number: 252-044-7
CAS number: 34455-00-0
An in vivo eye irritation and in vivo
skin irritation study were conducted on FBSEE diol. The
results of the studies were:
- Eye Irritation: Mildly irritating (not
classified) when tested according to OECD 405 (2002).
- Skin Irritation: Non-irritating when
tested according to OECD 404 (2002).
The primary eye irritation/corrosion
potential of the test article was evaluated in New Zealand White
Rabbits. The study was conducted in compliance with OECD GLP (1997). The
test method was based on OECD No. 405 (2002), EC No. 440/2008, EPA OPPTS
870.2400 (1998) and JMAFF guidelines (2011). Single samples of
approximately 64 mg of test article (a volume of approximately 0.1 mL)
were instilled in the conjunctival sac of one of the eyes of each
animal. The lids were held together for about one second to prevent loss
of the test substance. The remaining untreated eye served as the
control. The eyes were observed at 1, 24, 48, and 72 hours and 7 days
after instillation. Immediately after the 24-hour observation, a
solution of 2% fluorescein in water was instilled in both eyes of each
animal to quantitatively determine corneal epithelial damage. Corneal
opacity (maximum grade 1) and epithelial damage (maximum 35% of the
corneal area) that had resolved within 72 hours was observed in one
animal. Slight dulling of the normal luster of the cornea was noted in
the other two animals on Day 1. Iridial irritation (grade 1) was
observed in all animals and resolved within 24 hours. Conjunctivae
redness, chemosis, and discharge (maximum grade 2) was seen in all
animals but had resolved within 7 days. Individual animal average
corneal opacity scores (24-72 hours) were 0.7, 0.0, and 0.0. Individual
animal average iritis scores (24-72 hours) were 0.0 in all animals.
Individual animal average conjunctival redness scores (24-72 hours) were
2.0, 1.7, and 1.3. Individual animal average conjunctival chemosis
scores (24-72 hours) were 1.3, 0.3, and 0.7. Based on the results of the
study, the test article is a mild ocular irritant and has no obligatory
labeling requirements for eye irritation according to GHS.
The skin irritation
potential of the test article was evaluated in albino rabbits. The test
was conducted under OECD GLP (1997) conditions. The test method was
based on OECD No. 404 (2002), EC No. 440 (2008), US EPA, OPPTS 870.2500
(1998), and JMAFF Guidelines (2011). Three male rabbits were exposed to
0.5 grams of the test article moistened with water by application onto
clipped skin for 4 hours using a semi-occlusive dressing. Sites were
cleaned of residual test substance using tap water after 4 hours of
exposure. Animals were observed twice daily for mortality/viability, at
least once daily for toxicity, and body weight was taken on the day of
treatment (prior to application) and after the final observation. The
exposed sites were examined at 1, 24, 48, and 72 hours and scored for
erythema and edema. Erythema and edema scores of zero were reported at
all time points for all animals (PII=0.0/8.0). Based on the results of
the study (all scores 0, PII=0.0/8.0), the test article is not a skin
Based on the results of the studies,
FBSEE diol is not classified for ocular or dermal irritation according
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