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EC number: 203-227-5
CAS number: 104-68-7
2 guideline, reliability 1 studies are available for skin and eye irritation. a disregarded eye and skin irritation study is also available but not considered.No data are available for respiratory inhalation.Supporting data from the read across analogue phenoxy ethanol are available for reference only.
The acute dermal irritation/corrosion study in New Zealand White Rabbits
was conducted to evaluate the skin irritation potential of Diethylene
glycol mono phenyl ether.
Five-tenths of a milliliter (0.5 ml) of the undiluted test item was
applied to the dose site and covered with a gauze pad of size
approximately 6 cm2 (2 x 3 cm -6ply). A control patch blank gauze pad
was applied 3 – 4 cm anterior to the 4-hour test patch. All patches were
secured to the body of the animal by an adhesive tape and a crepe
bandage wrapped around the torso of the animal. After 4 hours contact
period the bandage was removed and the dose sites were wiped with water.
The degree of irritation was evaluated and scored by Draize’s evaluation
method at 1, 24, 48 and 72 hour post removal of the test patch. There
was no evidence of dermal irritation as evidenced by erythema and edema
score of ‘0’ was observed at all the observation time points.
There were no toxic signs, pre-terminal deaths and no skin reactions
observed. There were no abnormalities detected at necropsy.
Irritation scores calculated
The acute eye irritation/corrosion study in New Zealand White rabbits
was conducted to evaluate the eye irritation potential of Diethylene
glycol mono phenyl ether. One-tenth of a milliliter (0.1 ml) of the
undiluted test item was instilled into the conjunctival sac of the left
eye of the animal after gently pulling the lower lid away from the
eyeball. The eyelids were held together gently for about one second to
minimize loss of test item. The right eye remained untreated and served
as the reference control. All the rabbits were treated in a similar
manner. The ocular lesions were evaluated at 1, 24, 48, 72 hours, 4, 7,
10, 14, 17 and 21 days post instillation according to the scale for
scoring ocular lesions. In addition, the treated eyes were examined
using ophthalmic fluorescein sodium at 24, 72 hours, at 7 and 14 days
post instillation. The total mean scores were 18, 27.34, 27.34, 27.34,
25.34, 22.06, 34.67, 27.33, 27.33 and 18.67 at 1, 24, 48, 72 hours, 4,
7, 10, 14, 17 and 21 days, respectively. Mild circumcorneal injection
was observed in one rabbit from day 10 onwards and in the other two
rabbits from day 14 onwards till termination of observation (day 21).
There were no toxic signs and pre-terminal deaths.
Based on the evidence of irritation and the persistence of effects until
the end of the observation period, the test material meets the criteria
for Category 1 A according to CLP.
In a well conducted skin irritation test (GLP and Guideline) there was
no evidence of irritation in any animal at 1, 24, 48, or 72 hours post
exposure. This substance was therefore not considered to be irritating
to the skin.
In a well conducted eye irritation test (GLP and Guideline) the scores
for conjunctival redness and chemosis and the scores for corneal opacity
were 2, 2, and 1 (respectively) in at least 2 out of the 3 animals
tested. In addition, the corneal effect was still evident in all animals
at observation day 21. As such this substance is considered to be
irritating to the eyes.
No data on respiratory irritation are available, however given the low
vapour pressure of this substance and the absence of skin irritation it
is concluded that this substance will have a low potential for
The test material did not meet the criteria as irritating to the skin.
However in the eye irritation assay, the scores in 2 out of 3 animals
were sufficient to classify as Category 2a, irritating to the eyes. In
addition to this, the effects persisted (corneal effects) to the end of
the observation period (day 21) and so must be considered as severe, or
irreversible. Therefore this substance should be classified as Category
1 for eye irritation.
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