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EC number: 231-415-7
CAS number: 7540-51-4
These endpoints were fulfilled using read across from Citronellol
(3,7-dimethyl-6-Octen-1-ol, CAS 106 -22 -9).
The skin irritating potential of the test substance was assessed in two
in vitro human skin model studies.
The first study tested the substance in an in vitro topical test and in
vitro patch test using the Skin Ethic reconstituted epidermal tissue.
This study reported positive indication of irritation in both the direct
topical application and patch test and levels of IL-1α were increased
after treatment with the test item.
The second in vitro study was performed similar to OECD test guideline
431 and used the skin models EpiDerm, EPISKIN and PREDISKIN. This study
also reported an outcome of irritating.
Eye irritation was assessed in an in vivo study equivalent or similar to
OECD Guideline 405 and according to Federal Register 38, No. 187, Para.
1500.42, 5. 27029; 27.09.73. Six rabbits were treated with the test
item. All six rabbits had a corneal opacity score of 1, when calculated
as the mean grading at 24/48/72 hours. The substance was therefore
classified as Eye irritation, Category 2.
24h after application of 0,1 ml of test substance:
slight opacity of complete cornea and in 2/6 cases ciliary injections;
all animals: distinct redness and turgor/swelling of conjunctiva, increased secretion of tears and scarred retractions at the eyelid
redness and turgor of conjunctiva and secretion in regression
3/6 animals show very light opacity of small areas of cornea,
5/6 show slight redness of conjunctiva,
2/6 show slightly increased secretion of tears,
1/6 shows temporary suppuration,
1/6 shows temporary contraction of the pupil;
all animals: irreversible scarred alterations of the eyelid
irritation score: 31 -> moderately irritating
Skin corrosion / irritation
Skin corrosion is defined as the production of irreversible damage to
the skin following application of the test substance. Skin irritation is
the production of reversible damage to the skin following application of
the test substance.
In the in vitro skin topical application test and in vitro patch test,
the criteria for the positive control was a low cell viability was
measured by MTT reduction (<50%), and when a necrosed histology
(score<75) and an increase of the amount of secreted IL-1 α (≥30 pg/mL
in the topical test and ≥105 pg/mL in the patch test) were observed. In
the topical test a result of low cell viability, necrosed, and increase
in IL-1α was reported. In the patch test a result of high cell
viability, necrosed, and increase in IL-1α was reported. Therefore the
substance was considered as irritating under the conditions of this test.
In a second in vitro skin irritation study, carried out using methods
equivalent or similar to OECD 431, the exposure time required to
decrease tissue viability by 50% was measured. Under the conditions of
this test, the test item was predicted to be an irritant.
Considering the positive result in both in vitro tests, it was concluded
that the test substance should be classified as a skin irritant,
Category 2 according to CLP.
Serious eye damage is defined as the production of tissue damage in the
eye, or serious physical decay or vision following application of the
test substance to the anterior surface of the eye which is not fully
reversible. Eye irritation means the production of changes in the eye
following application of the test substance which is fully reversible.
Eye irritation was assessed using an in-vivo test method equivalent or
similar to OECD Guideline 405.
During in vivo testing, substances are classified as having irreversible
effects in the eye if at least in one animal effects on the cornea, iris
or conjunctiva that are not expected to reverse or have not fully
reversed within the observation period; or at least in 4 of 6 tested
animals, a positive response of corneal opacity ≥ 3 and/or iritis > 1,5
calculated as the mean scores following grading at 24, 48 and 72 hours.
A substance is classified as having reversible effects on the eye if
when applied to the eye of an animal, a substance produces: at least in
4 of 6 tested animals, a positive response of: corneal opacity ≥ 1
and/or iritis ≥ 1, and/or conjunctival redness ≥ 2 and/or conjunctival
oedema (chemosis) ≥ 2 calculated as the mean scores following grading at
24, 48 and 72 hours.
The test material induced mean corneal opacity scores (24/48/72 hr) of
1 in 6/6 rabbits. Therefore, according the CLP criteria, the substance
is classified as Eye irritation, Category 2.
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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