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EC number: 208-807-1
CAS number: 542-28-9
No death occured during the study.
No symptoms of local toxicity at the ears of
the animals and no systemic findings were observed during the study
The body weight of the animals, recorded
prior to the first application and prior to treatment with 3HTdR, was
within the range commonly recorded for animals of this strain and age.
Lymph nodes weights and cell count
The measured lymph node weights and –cell
counts of all animals treated were recorded after sacrifice. A
statistically significant or biologically relevant increase in lymph
node weights or cell counts was not observed in any of the test item
treated groups in comparison to the vehicle control group. For BALB/c
mice, a cutoff-value for the lymph node cell count index of 1.55 was
reported for a positive response. The indices determined for the lymph
node cell count did not exceed this threshold.
The measured ear weights of all animals
treated were recorded after sacrifice. A statistically significant or
biologically relevant increase in ear weights was not observed in any
treated group in comparison to the vehicle control group. For BALB/c
mice, a threshold for the ear weight index of 1.1 was reported for a
positive response. None of the indices determined for the test item
treated groups exceeded this threshold.
Local Lymph Node Assay
In a dermal sensitization study
(Harlan CCR, 2012) with Delta-Valerolactone solved in dimethylformamide,
female mice (CBA/CaOlaHsd) were tested using the method of Local Lymph
Node Assay (LLNA). In this study, Stimulation Indices (S.I.) of 1.56,
1.23, and 1.06 were determined with the test item at concentrations of
25, 50, and 100% (w/w) indimethylformamid, respectively. An EC3 value
was not calculated, because all S.I.s were below the threshold value of
3 for a positive response. A periodic positive control experiment was
performed in December 2011 with alpha-Hexylcinnamaldehyde (vehicle:
acetone: olive oil (4+1 v/v)), demonstrating the sensitivity and
reliability of the experimental technique. Animals did not show any
signs of systemic toxicity or local skin irritation during the study
period. No deaths occurred during the study period.
Delta-Valerolactone was not a skin
sensitiser under the test conditions of this study.
Classification is not warranted according to
the criteria of EU Directive 67/548/EEC and EU Classification, Labelling
and Packaging of Substances and Mixtures (CLP) Regulation (EC) No
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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