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EC number: 939-253-5
CAS number: 68424-85-1
Due to the hygroscopic behaviour the
substance deliquesced when it was bought to air for several minutes.
study was conducted to determine the appearance, physical state and
colour of the test substance according to EPA OPPTS 830.6302, .6303 and
.6304, in compliance with GLP. Under
the study conditions, the substance was a crystalline, hygroscopic,
sticky white solid with a faint marzipan-like odour at 20ºC (Schulze,
vapour pressure was determined using the isothermal thermo gravimetric
effusion method according to OECD Guideline 104, EU Method A.4 and EPA
OPPTS 830.7950 (Brekelmans, 2012).
on the available information and in line with the biocides assessment
report, the test substance is non-sensitising to the skin.
modified Draize test was conducted to determine the skin sensitisation
potential of the test substance, C12 -16 ADBAC (50% active in water)
according to EU Method B.6. For the induction phase, 0.1 mL of 0.1% test
substance in the water was injected intradermally into the back of each
six guinea pigs. This procedure was repeated every other day, using a
different injection site on each occasion, until a total of nine
injections had been given. Injection sites were examined 24 h after each
injection and scored for erythema and oedema using the Draize scale.
After a two-week interval, a single challenge intradermal injection of
the same concentration and volume was given as for induction. Injection
sites were examined 24 h after this challenge dose as before for
erythema and oedema. The effects were compared to those produced by the
priming doses to determine whether sensitisation had been produced. The
priming injections elicited very slight to well-defined erythema, and
very slight to slight oedema on all occasions. The challenge dose
produced well-defined erythema and very slight oedema on all occasions.
However, the challenge doses did not produce any greater reaction in any
animal. Under the study conditions, the test substance was not
considered sensitizing to guinea pig skin (Thomas, 1974).
Buehler test was conducted to determine the skin sensitisation potential
of the test substance, C12-16 ADBAC (80.9% active in water/alcohol)
according to OECD Guideline 406 and US EPA OPPTS 870.2600, in compliance
with GLP. The study was conducted in two phases, with induction and
challenge exposures. To determine the highest non-irritating
concentration (HNIC) for the challenge phase, a preliminary irritation
study was performed with 8 guinea pigs. The concentrations used were
100, 75, 50, 25, 1.25, 1.0, 0.75, 0.25 and 0.10%. w/w in distilled
water. After treatment, the application sites were evaluated and scored.
During the induction phase of the main study, 0.4 mL of a 1% w/w mixture
of the test substance in distilled water was applied to the left side of
each animal, once per week for three weeks. Twenty-seven days after the
first induction dose, 0.4 mL of a 0.25% w/w (HNIC) mixture of the test
substance in distilled water was applied to a naïve site on the right
side of each test animal for challenge exposure. Ten additional animals
exposed with 0.25% w/w mixture of the test substance in distilled water
served as naive control group in the challenge phase only. Approximately
24 and 48 h after each induction and challenge dose, the animals were
scored for erythema. Very faint to faint erythema (0.5 to 1) was
observed in all test animals during induction. None of the test animals
exhibited a positive skin sensitisation response (score greater than
0.5) at 24 or 48 h after challenge. Under the test conditions, the test
substance was determined to be non-sensitising when applied topically to
albino Hartley guinea pigs (Durando, 2005).
guinea pigs maximisation test (GPMT) was conducted to determine the skin
sensitisation potential of the test substance, C12 -16 ADBAC (purity not
specified) according to the Magnusson and Kligman method. Female albino
guinea pigs received on Day 1 an intracutaneous injection of 0.1 mL of
0.1% test substance in isotonic saline with Freund's complete adjuvant
(1:1) on the shaved part of the flank (approximately 6 x 4 cm). On Day
7, animals have applied an epicutaneous occlusive application for 48 h
with 0.3 mL of 0.1% test substance in ethylene glycol monomethylether,
water, Tween 80 (180/180/40) v/v. Finally, on Day 21, guinea pigs were
challenged epicutaneously (open application) with 0.05 mL of test
substance in water at the shaved ventral side of the animal. The
response was monitored after 24 and 48 h next to a control group of 10
animals. Concentrations were previously ascertained by both
intracutaneous and epicutaneous applications to determine irritation
potential in three animals at 24 and 48 h, respectively. In all the
cases non-irritating concentrations were chosen. At 24 h after
challenge, 4/20 animals showed a positive response consisting of slight
erythema. After 48 h, 2/20 animals showed a slight macular erythema.
Under the conditions of this study, the test substance was negative for
skin sensitization (Schallreuter, 1996).
study similar to a GPMT was conducted to determine the skin
sensitisation potential of the test substance, C12-16 ADBAC (50% active
in water) in albino guinea pigs. Five test animals were used for the
study. The concentration of the test substance for the induction and
challenge phases were an intradermal induction with 10 injections of
0.1% in water every alternate day and a challenge with 1 injection of
0.1% in water two weeks after the 10th induction injection. Very slight
erythema and oedema were noted 24 h after the challenge, but these
reactions after the challenge were not substantially different from
those after the induction injections. Under the study conditions and
although the number of test animals was limited, the test substance was
considered as a non-sensitising to guinea pig skin (Anonymous, 1969).
study similar to the Buehler test was performed to assess the skin
sensitisation potential of the test substance, C12-16 ADBAC (0.1% active
in water) in the albino guinea pig. Ten male test animals were used for
the study. The concentration of the test substance for the induction and
challenge phases were first an epicutaneous induction of 8 applications
of 0.1% in water every day and then an epicutaneous challenge of 1
application of 0.1% in water two weeks after the 8th induction
application. No skin reactions were noted 24 h after the first induction
application and 24 h after the challenge. Under the study conditions and
although the number of test animals was limited, the test substance was
considered as a non-sensitising to guinea pig skin (Hixson, 1968).
more skin sensitisation studies (Basketter 1996, 1998) were identified
for the test substance, C12-16 ADBAC (purity not specified) from
literature sources, which compared the skin sensitisations results
obtained from standard guinea pig tests with Local lymph mode assay
(LLNA). The Basketter (1996) study compared the results obtained with
various substances, including the present test substance, in an LLNA
assay, a GPMT and a Buehler test. Although the test substance was
evaluated as non-sensitising in the guinea pig test, the LLNA result was
positive. As per the study authors, the LLNA test, however, can give
false-positive results for strong irritants (as does the GPMT test), as
was demonstrated by the non-sensitising irritant sodium dodecyl sulphate
which was tested positive in the LLNA. To evaluate possible
false-positive results, a range of non-sensitising irritant chemicals,
including the test substance were tested in the LLNA (Basketter, 1998).
The stimulation index for the test substance did not exceed the factor 3
and thus the outcome was considered negative by the study authors. Under
the study conditions and based on the literature data of LLNA, the test
substance was not considered to be a skin sensitiser (Basketter, 1996
the Biocides assessment report on C12-16 ADBAC, published by the Italian
authorities in June 2015, concluded that the test substance is not a
skin sensitiser under the experimental conditions tested. Although no
experimental data is available, C12-16-ADBAC/BKC is not expected to be a
respiratory sensitizer (ECHA biocides assessment report, 2015).
based on the available information and in line with the biocides
assessment report, the test substance is non-sensitising to the skin.
per the Biocides assessment report on C12-16 ADBAC, published by the
Italian authorities in June 2015, although no experimental data is
available, C12-16-ADBAC is not expected to be a respiratory sensitizer
(ECHA biocides assessment report, 2015).
on the absence of skin sensitisation responses in available in vivo
studies, the test substance does not warrant a classification for the
skin sensitisation endpoint, according to the EU CLP criteria
(Regulation 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.
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