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EC number: 271-237-7
CAS number: 68526-89-6
A complex combination of hydrocarbons produced by the distillation of products from the hydrogenation of isononanal from the hydroformylation of octene. It consists predominantly of C9-10 primary aliphatic alcohols, C10-20 dimer alcohols, C>18 acetals and esters and C>18 acid sodium salts and boils in the range of approximately 200°C to 400°C (392°F to 752°F).
GMPT: negative (BASF 1994)
LLNA: positive, EC 3 = 29% (Evonik, 2002)
in vitro: positive (BASF, 2017)
* Disintegration per minute/node obtained by dividing the disintegration
per minute value by 8 (total number of lymph nodes)
There were no deaths. No signs of systemic toxicity were noted in the
test or contral animals during the test. Bodyweight changes of the test
animals between Day 1 and Day 6 were comparable to those observed in the
corresponding control group animals over the same period.
In the preliminary test after two 24-hour percutaneous occlusive
applications within 96 hours the unchanged test substance was found to
Intradermal injection of 5% of the test substance caused topical
reactions as described below.
Control group animals (Freund's adjuvant : 0.9% aqueous NaCI-solution
1:1): well-defined erythema and slight edema was observed at the
Control group animals (olive oil DAB 10): well-defined erythema.
Test group animals (Freund's adjuvant : 0.9% aqueous NaCI-solution 1:1):
well-defined erythema and slight edema was observed at the injection
Test group animals (test substance preparation in olive oil DAB 10):
well-defined erythema (20/20) animals and very slight edema (7/20)
Test group animals (test substance preparation in Freund's adjuvant :
0.9% aqueous NaCI-solution 1:1): well defined erythema and slight edema.
Test group: incrustation, partially open (caused by the intradermal
induction) in addition to well-defined erythema and slight edema.
Test group: 4/20 animals exhibited very slight erythema.
Control group 1: no skin reactions
Control group 2: no application of the test substance
Test group: no skin reaction
Control group 1: no skin reaction
Control group 2: no skin reaction
1st Challenge – Test group
24, 48 h
Mean 24, 48 h
2nd Challenge – Test group
Positive control: (data
derived from project no. 30H0267/922123, 20.09.1993 )
1-chloro-2,4-dinitrobenzene 0.5% in EtOH
Control group 1
Control group 2
no application of 1-chloro-2,4-dinitrobenzene
After application of the test substance no abnormalities in the body
weight gain were observed in the treated animals. No additional findings
The test substance was tested for its sensitizing effect on the skin of
the guinea pig in the Maximization test based on the method of Magnusson
and Kligman according to OECD Guideline 406 (BASF AG, 30H0116/932042,
1994). The intradermal induction with the 5% test substance preparations
caused very slight to well-defined signs of irritation in the test group
animals. After percutaneous induction with the unchanged test substance
incrustation, partially open (caused by the intradermal induction) in
addition to well-defined erythema and slight edema could be observed in
the test group animals. The first challenge with the unchanged test
substance caused very slight erythema in 4 out of 20 test group animals
24 hours after removal of the patches. After the second challenge no
skin reactions could be observed. Based on the results of the study
under the test conditions chosen it was concluded that the test
substance does not have a sensitizing effect on the skin of the guinea
pig in the Maximization Test .
In an LLNA according to OECD 429, CBA/CA mice were treated with 25, 50,
and 100% of the registered substance in aceton/olive oil. Based on a
pre-test, all concentrations should not cause excessive irritation.
Lymph nodes were pooled per group. Concentrations of 50% and 100% caused
a relevant increase in radioactivity. The EC3 value was calculated as
In vitro assays according to OECD 442C, D, E
The three tests used in the “2 out of 3” testing strategy assess protein
binding in chemico (DPRA), triggering an antioxidant response in
keratinocytes (LuSens) and activation of dendritic cells (h-CLAT), which
cover different key events of the skin sensitization Adverse Outcome
Pathway. In the DPRA, no or minimal peptide binding was observed.
However, it should be noted that due to the limited solubility of the
test substance the samples with both peptides were emulsions and that
the result could therefore be under-predictive. Following OECD TG 442C a
“negative” result should be considered “inconclusive” in this case.
Luciferase activity was enhanced more than 1.5 fold in at least two
consecutive concentrations in tow independent experiments at a cell
viability above 70%. The EC1.5 value was 1.5µg/ml. No activation of CD86
was observed in dendritic cells, but expression of CD54 was enhanced
more than 2 fold in at least two independent experiments. Consequently,
two positive results were obtained in the LuSens and h-CLAT and one
inconclusive result in the DPRA. Following the overall evaluation
strategy, the substance is considered a sensitizer in this test system.
Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008
In a weight of evidence approach, the substance is considered a moderate
skin sensitizer. Based on the overall positive result in the in vitro
assays and the EC3 value obtained in the LLNA assay of 29%,
classification according to GHS, EU as skin sensitizer cat. 1B is
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