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EC number: 906-170-0
CAS number: -
Neither classified as a skin or eye irritant
DBE has been tested for skin irritation on 3 New Zealand White rabbits
according to OECD guideline n° 404 and EU guideline n° B.4 (Draize
Method) in compliance with Good Laboratory Practice. The rabbits
received a dermal dose of 0.5 ml of DBE on a gauze on intact and abraded
skin sites under an semiocclusive dressing for a period of 24 hours.
Scores for erythema and oedema were measured 1, 24, 48 and 72 hours
after patch removal and primary cutaneous index was calculated (maximum
possible index =12)
No sign of dermal irritation (score = 0 for erythema and oedema) was
observed for intact skin site of the 3 rabbits at any reading time.
Primary Irritation Index was = 0.0. No other signs of intoxication were
Based on these results DBE is not classified irritating to skin
according to the criteria of the Directive 67/548/CEE and according to
EU Regulation 1272/2008 (CLP).
The observed effects on the conjuctivae and on chemosis 1 hour after
application were moderate in two animals and marked in one animal.Two
days after the applicaton of the test article, all ocular effects have
The eye irritating potential of the test article RP/DE has been
investigated in the rabbit under the OECD Guideline 405 and under GLP
Regulations. Moderate effects on the conjunctiva and on chemosis were
observed in two animals 1 hour after application of the test article
while the same effects were marked in one animal. Two days after
application of the test article, the effects had disappeared. Under the
conditions of this study, the test article RD/DE was considered not
irritating to the eye.
Two in vivo studies
using rabbits are available for skin irritation. One study (Clouzeau,
1987) was of reliability 1 according to Klimisch cotation criteria and
was therefore selected as the key study. The other study (Sarver, 1989)
was of reliability 2 according to Klimisch cotation criteria and was
used as a supporting study. In the key study, no signs of skin
irritation (erythema or edema) was observed following a 4-hour
semi-occlusive application of the test substance to the shaved skin of 3
rabbits and observation up to 72 hours after the end of application. In
the supporting study, the skin reactions were very variable from one
rabbit to another. At the 72-hour observation timepoint, one rabbit
exhibited severe erythema with fissuring of the skin and slight edema,
whereas no to mild erythema was observed in the 5 other animals. One
rabbit exhibited no dermal irritation at all throughout the observation
period. Considering the mean values for erythema :
Erythema mean score
Global mean value
the incidence of
scores of 2 or more was below 2/3 animals, and the global mean value
over all the animals tested was lower than 2. Therefore the results of
the supporting study are consistent with those of the key study and
support the absence of classification for skin irritation.
Three in vivo studies
using rabbits are available for eye irritation:
- In the study
selected as a key study based on its reliability 1 according to Klimisch
cotation criteria (Clouzeau, 1987), moderate conjunctival and chemosis
effects were observed in 2 animals one hour after instillation, and only
slight conjunctival redness was noted 24 hours after instillation. All
effects were fully reversible within 2 days after application. The
intensity and duration of the signs of irritation therefore did not
warrant any classification.
- In another study
considered of reliability 2 according to Klimisch cotation criteria
(Valentine, 1993), signs of ocular irritation were observed in 1 out of
the 4 rabbits tested. However, a low volume of instillation (10 µL) was
used and the observation period was limited to 48 hours after
instillation. No reliable conclusion could be made from this study.
However, consistently with the key study, no major sign of eye
irritation was observed.
- In the third study,
considered of reliability 3 according to Klimisch cotation criteria due
to the low number of animals used and the low level of details provided
regarding the ocular observations (Silber, 1980), signs of irritation
were observed in the unwashed eye of a single rabbit, which may have
been susceptible. Such data are therefore inappropriate for
Overall, the results
of in vivo testing indicate the absence of a need for classification for
The incidence and
severity of the signs of irritation observed among those different
studies were below the criteria of Annex VI Directive 67/548/EEC or EU
Regulation 1272/2008 (CLP), therefore warranting no classification for
skin or eye irritation.
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