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EC number: 228-973-9
CAS number: 6381-77-7
Skin irritation: Not irritatingSerious eye damage/eye irritation: Not irritating
In a primary dermal irritation study, 6 rabbits were dermally exposed to
2000 mg/kg 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone (test
site moistened with physiological saline) to intact and abraded skin.
Test sites were covered with an occlusive dressing for 24 hours.
No erythema, edema, or other signs of dermal irritation were observed at
five of six test sites. One rabbit (abraded skin) had slight erythema at
24 hours that cleared by 48 hours. In this study,
2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lacton is not a dermal
In a primary eye irritation study, 100 mg of
2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone powder was
instilled into the conjunctival sac of albino rabbits (10 male and 2
female). The eyes of half of the treated rabbits were rinsed after 5
seconds. Animals were then observed for 2 days. Irritation was scored
by the method of Draize.
One hour after dosing, two of six unrinsed eyes had congestion of the
iris, but the iris reacted normally to light. Varying degrees of redness
were observed in the lids of all unrinsed eyes. Slight redness of the
nictitating membrane or palpebral conjunctiva at the medial canthus was
observed in two unrinsed eyes.
At one hour, 1+ iritis was observed in one rinsed eye. Five of six
rinsed eyes had slight redness that was limited to only the nictitating
membrane in three cases. At 24 hours, all eyes were normal, with the
exception of one that had slight reddening of the conjunctiva at the
medial canthus. All eyes, rinsed and unrinsed, were normal at 48 hours.
The mean ocular irritation scores were 0.33/110 (unrinsed eyes) and
0.17/110 (rinsed eyes).
In this study, 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone is
not an eye irritant.
An in vivo skin irritation study (basic methodological details provided)
was available. Animals were exposed (abraded and intact skin) under
occlusive conditions for 24 hours. Skin reactions were evaluated at 24h,
48h and 72 hrs after exposure and no scoring scale was indicated. One
rabbit (abraded skin) had slight erythema at 24 hours that cleared by 48
hours. Based on the results from the in vivo study,
2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone was classified as
non- irritating. The results from this study are acceptable to use in
the human health risk assessment.
Serious eye damage/eye irritation:
An in vitro eye irritation study was not required as an in vivo study
was available. The in vivo study (basic methodological details provided)
was conducted according to an older test method and six albino rabbits
were used for each treatment (rinsed and unrinsed). The CLP regulation
does not provide criteria for the evaluation of such studies. The
current US EPA/UN Recommendations were considered as indicated in
‘Guidance on the application of the CLP criteria’, version 3.0, November
2012. Transient reactions (iritis, redness) were noted in unrinsed and
rinsed eyes. All eyes, rinsed and unrinsed, were normal at 48 hours. The
mean ocular irritation scores were 0.33/110 (unrinsed eyes) and 0.17/110
(rinsed eyes). Based on these criteria,
2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone is not an eye
irritant. The results from this study are acceptable to use in the human
health risk assessment.
Based on the available information in the dossier, the substance
2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone (CAS No. 6381-77-7)
does not need to classified for skin irritation/corrosion and does not
need to classified for serious eye damage/eye irritation when
considering the criteria outlined in Annex I of 1272/2008/EC.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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