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: 297-025-4
CAS number: 93281-13-1
3 out of 20 animals of the first and
second challenge showed positive erythema reactions after the 24-hour
reading when treated with a 25 % test article dilution. No positive
erythema reactions were observed when the animals were treated with
vaselinum album alone.
2 out of 20 animals after the second
challenge showed positive erythema reaction after the 24- and 48-hour
reading when treated with a 10 % test article dilution.
Mortality / viability
No death occurred.
Clinical signs, local
Application area around the injection site
1 was found to show erythema and edema from day 2 to 5; necroses were
observed from day 6 to 14; encrustations from day 12 to 19 and
exfoliation from day 18 to 39. Around the injection site 2 edema were
observed from day 2 to 5; staining from day 2 to 8; necroses from day 6
to 14; encrustation from day 12 to 19 and exfoliation from day 18 to 32.
Around the injection site 3 edema were
observed on days 2 and 3, staining from day 2 to 8, necroses from day 4
to 14, encrustations from day 12 to 19 and exfoliation from day 18 to
39. In addition epidermal induction application area, first challenge
and second challenge application areas showed staining respectively from
day 10 to 28, 23 to 28 and 37 to 39. On day 9 of test no observation
could be performed because the animals were bandaged semi-occlusively.
Clinical signs, systemic
No systemic symptoms were observed.
Females no. 533 and 536 of epidermal
pretest and females no. 514, 517 and 524 of test group lost slightly
weight during the acclimatization period.
They had recovered again during the
remaining study period. The body weight gain of the further animals was
not affected adversely during the study.
No positive reactions were evident after
the first and second challenge application, neither when treated with
vaselinum album nor when treated with a 25 % the test article dilution.
Application area around the injection
sites 1 and 3 was found to show erythema and edema from day 2 to 6;
necroses were observed from day 7 to 14; encrustations from day 12 to 20
and exfoliation from day 20 to 39 (termination of test).
In addition around the injection site 2
erythema and edema were observed on day 2 of test and first challenge
application area showed staining from day 23 to 28.
RESULTS OF THE FIRST CHALLENGE
Control group - test article treated (25 %
in vaselinum album) - Left flank
Control group - vehicle (vaselinum album)
- Right flank
Test group - test article (25 % in
vaselinum album) - Left flank
Test group - vehicle (vaselinum album) -
RESULTS OF THE SECOND CHALLENGE
Control group - vehicle (vaselinum album)
- Left flank.
Test group - test material (25 % in
vaselinum album) - Right flank.
Test group - test material (10 % in
vaselinum album) - Anterior left flank.
Test group - Vehicle (vaselinum album) -
Posterior left flank.
For the assessement of the skin
sensitisation potential of the test material to albino guinea pig the
Guinea Pig Maximisation test was performed, according to the OECD
Guideline 406. Twenty females were initially exposed to the test
substance by intradermal injection (5 % in vaselinum album) and
epidermal application (25 % in vaselinum album) (induction exposure).
Following a period of 14 days (induction period), the animals were
exposed to a challenge dose (25 %). A second challenge was performed two
weeks after the first challenge; the animals were treated with an
additional concentration of 10 % in vaselinum album. The extent and
degree of skin reaction to the challenge exposures in the test animals
was assessed immediately and after 24 and 48 hours following challenge
exposure. The skin reactions and the number of animals presenting these
skin reactions were compared with that demonstrated by control animals
which underwent sham treatment during induction and received the
The animals in the control group showed no
reaction at the substance after both the challenge exposures. At the
first challenge and second challenge exposure three out of twenty
animals (15 %) of the test group presented positive erythema reactions
after the 24 - hour reading, that were not present after 48 hours, when
treated with a 25 % test article dilution. Two out of 20 animals (10 %)
after the second challenge showed positive erythema reaction after the
24- and 48- hour reading when treated with a 10 % test article dilution.
The test group presented a skin sensitisation rate of 10 -15 % in
comparison with the control group that presented 0 % of rate.
The substance is considered to be a non
skin sensitiser to albino quinea pigs.
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.
På den här webbplatsen används kakor. Syftet är att optimera din upplevelse av den.
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