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EC number: 285-550-1
CAS number: 85116-97-8
irritation: not irritating
Eye irritation: not irritating
The hazard assessment is based on the data currently available. New
studies with the registered substance and/or other member substances of
the glycol esters category will be conducted in the future. The
finalised studies will be included in the technical dossier as soon as
they become available and the hazard assessment will be re-evaluated
For further details, please refer to the category concept document
attached to the category object (linked under IUCLID section 0.2)
showing an overview of the strategy for all substances within the glycol
Individual skin reaction scores
Table 2: Viability of HCE tissues - Individual data
Relative mean viability (%)
1: Solution A (supplied by SkinEthic)
2: sodium dodecyl sulphate (2% in sterile water)
The target substance Fatty acids, C16-18, esters with diethylene
glycol was tested for its potential to induce skin irritation similar to
OECD 404. Due to the limited data available, read across to the analogue
substance ethylene distearate (CAS 627-83-8) is considered additionally
to allow hazard evaluation based on a weight-of-evidence approach.
Fatty acids, C16-18, esters with diethylene glycol was tested in a
study similar to OECD guideline 404 (EViC-CEBA, 1994). The results of
the conducted study were reported in a summary with limited information.
However, as basic data are provided sufficient for hazard assessment,
the study was considered as reliable (RL 2).The test substance was
topically applied to the skin of 3 male New Zealand White rabbits. The
treated skin was observed and evaluated at 1, 24, 48 and 72 h
post-application. The animals were observed for a time period of 5 days.
Very slight erythema (score 1) were observed in all test animals
starting 1 h after patch removal which were stable up to the 72 h
reading time point. Moreover, slight edema (score 2) were determined in
1/3 animals 1 h after application which was still visible as very slight
edema (score 1) up to the 72 h reading time point. The remaining animals
revealed very slight edema (score 1) at the 1 h reading time point which
were reversible 24 h later. Latest on Day 5 after test substance
application, the skin reactions were fully reversible. Based on severity
of local reactions and the reversibility of skin reactions, the test
substance Fatty acids, C16-18, esters with diethylene glycol is not
considered to exhibit skin irritating properties.
The skin irritation properties of ethylene distearate have been
investigated in several studies (CAS 627-83-8).
The skin irritation properties of ethylene distearate were tested
in a study equivalent to OECD guideline 404 (Product Safety Labs 1991a).
In the study, 3 male and 3 female New Zealand White rabbits were exposed
to 0.5 g of the unchanged test substance, applied to the shaved and
abraded skin for 25 h using an occlusive dressing. The treated skin was
observed and evaluated at 25 and 72 h post-application. No erythema or
edema was observed in any animal during the study period on intact
shaved skin. On abraded skin, slight erythema in 2 animals was observed
at 25 h, being fully reversible within 72 h. No further local or
systemic effects were apparent in any animal during the study period.
In an equivalently conducted study from the same laboratory
(Product Safety Labs, 1991b), the results of the above discussed study
were confirmed. No erythema and no edema formation were observed in the
test animals on intact skin and erythema on abraded skin was fully
reversible within 72 h. No other local or systemic effects were
The target substance Fatty acids, C16-18, esters with diethylene
glycol was tested for its potential to induce eye irritation in a
reconstructed Human Corneal Epithelium model. As the applied model
system is not formally validated, read across to the analogue substance
ethylene distearate (CAS 627-83-8) is considered additionally to allow
hazard evaluation based on a weight-of-evidence approach.
Triplicates of reconstructed Human Corneal Epithelium (HCE)
tissues were treated with the test substance. The used SkinEthic HCE
model is based on the hypothesis that irritant chemicals are able to
penetrate the corneal epithelial tissue and are sufficiently cytotoxic
to cause cell death. The test method was designed to be compatible with
the prevalidation protocol published by Van Goethem et al., 2006
(Prevalidation of a new in vitro reconstituted human cornea model to
assess the eye irritating potential of chemicals). The method follows
parts of the currently ongoing Colipa/ECVAM Eye Irritation Validation
In this study, appropriate sized discs of the test item were
prepared for direct application to the tissue culture surface to enable
adequate contact between the test substance and the tissue culture
surface. The discs stayed in contact with the SkinEthic HCE tissues for
10 min. Afterwards, each tissue was rinsed with Dulbecco's Phosphate
Buffered Saline without Ca 2+ and Mg 2+. Rinsed tissues were loaded with
MTT solved in maintenance medium for approx. 3 hrs. After MTT-loading
the tissues were immersed in isopropanol for extraction of formazan
crystals. After extraction the absorbency of triplicate aliquots of the
extracted MTT solution for each SkinEthic tissue was measured at 562 nm.
The relative mean viability of test substance treated tissues was 95.7%.
The relative mean tissue viability for the positive control treated
tissues was 38.1% relative to the negative control treated tissues
thereby indicating validity of the conducted test. As incubation with
the test substance did not reduce relative tissue viability below the
defined cut off level of 60%, the test substance is not considered to
exhibit eye irritating properties based on the results of the conducted
The eye irritation properties of ethylene distearate were tested
in a study similarly performed to OECD guideline 405 (Product Safety
Labs, 1991). In a group of 6 New Zealand white rabbits, 0.1 g of the
test substance was applied into the eye. Observation of the eyes was
performed 24, 48 and 72 h after application. No effects on cornea and
iris were noted in any animal during the study period. However, mild
conjunctival redness was observed in 4/6 animals after 24 h and in 2/6
animals moderate redness was apparent. In 2 animals the mild redness was
still persistent after 72 h with a mean score of 0.78 over 24, 48 and 72
h out of all 6 animals. Chemosis was observed in 1/6 animals after 24 h
being fully reversible within 48 h. No chemosis was observed in the
remaining 5 animals during the study period. No further systemic effects
or abnormal behaviour were observed in any animal during the study
Conclusion on skin and eye irritation properties
The available studies on irritation performed with the target and
an analogue substance indicate no irritating properties towards the skin
or eyes for the tested substances. Therefore, based on these data, Fatty
acids, C16-18, esters with diethylene glycol is not considered as skin
or eye irritant.
Based on test substance-specific data and on analogue read-across
approach, the available data on skin and eye irritation do not meet the
classification critera according to Regulation (EC) 1272/2008, and are
therefore conclusive but not sufficient for classification.
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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