Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 201-121-3
CAS number: 78-50-2
Based on available data, the substance is considered to be irritating to skin but not to eyes.
Primary Irritation Index (PDII) was calculated by adding mean
erythema/eschar and edema values on the 4 h exposure, of all animals at
24 and 72 h (a total of 4 values) and dividing the sum by 2.
Calculation of Modified Primary Irritation Index (PDII):
Mean erythema scores
Mean edema scores
of Mean Scores =7.00
Primary Irritation Index (PDII) = Sum of Mean Scores/2 = 3.50
A study was
conducted to evaluate the skin irritation potential of the test
substance in rabbits according to OECD Guideline 404, in compliance with
GLP. 0.5 g of test substance was moistened with 0.5 mL of distilled
water to form a pasty consistency and applied at each test site under a
2.5 x 2.5 cm gauze patch, using semi-occlusive conditions. After an
exposure period of 4 h, the wrappings and patches were removed and the
sites gently washed with distilled water. The test sites were scored for
signs of dermal irritation at 1, 24, 48 and 72 h as well as on Day 7, 14
and 17 after removal of the patches. Erythema and edema were scored
according to the numerical Draize technique. The skin was also evaluated
for ulceration and necrosis or any evidence of tissue destruction.
Additional clinical signs were noted. Under the study conditions, the
test substance was found to be irritating to skin (DiDonato LJ, 2010).
A study was
conducted to evaluate the eye irritation potential of the test substance
in rabbits according to OECD Guideline 405, in compliance with GLP. Test
substance (0.1 mL, which is equivalent to 61.3 mg) was instilled in one
eye of three New Zealand White rabbits with the help of a syringe-type
applicator. The contralateral eye served as control. The treated and
control eyes of each rabbit were examined for irritation of the cornea,
iris and conjunctiva at 1, 24, 48 and 72 h following instillation of the
test substance. The eye was examined with the aid of an ultraviolet
light source. Ocular reactions were graded according to the numerical
Draize technique. Toxicity and pharmacological effects were recorded at
each ocular observation period and mortality was checked daily. All
animals were humanely sacrificed using C02following study
termination. There was no corneal opacity or iritis noted at any
observation period. Conjunctival irritation, seen all animals, cleared
in one eye by 24 h and in the other two by 72 h. The control eyes
appeared normal at all observation periods. No abnormal physical signs
were recorded. Under the study conditions, the test substance was not
irritating to eyes (Hall DA, 2010).
A study was
conducted to assess the skin irritation potential of the test substance
to rabbit skin according to the modified Federal Hazardous Substance Act
procedure. 0.5 mL of a 40% suspension of the test substance was applied
to the skin of the test animals in corn oil under covered patch. Tissue
structure at the site of contact was destroyed irreversibly within 24 h.
Mean erythema scores at 24 h as well as 72 h in intact and abraded skin
were 3.83. Mean edema scores in intact and abraded skin were 3.67 at 24
h and 3.17 at 72 h. Under the study conditions, the test substance could
be considered corrosive based on the irreversible damage observed at the
site of contact (Brown DR, 1979). However, no details on the test method
are available. The study was therefore considered unreliable.
A study was
performed to assess the irritation potential of the test substance to
rabbit eye according to the Federal Hazardous Substance Act
procedure.100 mg of test substance were applied to the eyes of 6 New
Zealand White rabbits. The degree of eye irritation/corrosion was
evaluated by scoring lesions of conjunctiva, cornea and iris. No lesion
in the iris was observed at any time point. A mean corneal score of 1.67
was observed at 24 h, which was fully reversible within 72 h. A mean
conjunctivae score of 6.0 was observed at 24 h, which was not reversible
until 72 h. Under the study conditions, the test substance was positive
for eye irritation according to the criteria under Federal Hazardous
Substance Act procedure (Brown DR, 1979). However, no details on the
test method are available. The study was therefore considered unreliable.
Based on the
available in vivo skin irritation studies, the test substance is
classified as Skin
irritation, Category 2 - H315 (causes skin irritation) according
to CLP (EC 1272/2008).
Based on the
results of the eye studies, the test substance does not need to be
classified for this endpoint according to CLP (EC 1272/2008).
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again