Registration Dossier
Registration Dossier
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EC number: 260-754-3 | CAS number: 57472-68-1
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Additional information:
There are valid in vivo data available for the assessment of the skin sensitization potential of DPGDA.
A Local Lymph Node Assay (LLNA) was conducted in mice, according to OECD guideline 406 (Central Toxicology Laboratory 2000, Val. 1). The application of the test substance at concentrations of 3%, 10% and 30% w/v in acetone resulted in an increase in isotope incorporation which was greater than 3-fold at all concentrations (0 % vehicle only: 3431 dpm; 3 %: 67078 dpm; 10 %: 62324 dpm; 30 % 60335 dpm). Consequently, the test substance was shown to be a potential skin sensitiser. Following the third application, the ears of animals dosed with 10% and 30% w/v preparations were red and, for the following 3 days, the ears were also swollen and sensitive to touch. The ears of animals dosed with the 3% w/v preparation were red on the day following the third application.
For the sensitising potential of the test substance, a qualitative assessment was conducted:
The derivation of an EC3 was not possible. The available LLNA data indicates that the EC3 is definitely below 3 %. However, taking into account the observed irritating effects on the ears, and the missing dose-dependency of the lymph node proliferation, the sensitising effect cannot be clearly discriminated from at least partly possible lymph node proliferation based on skin irritancy.
If taking into account data from similar substances, it can be excluded that the test substance is an strong or extreme sensitiser.It can therefore be concluded that the test substance is a moderate sensitiser.
Migrated from Short description of key information:
Mouse, LLNA: sensitizing (acc. OECD 406, Central Toxicology Laboratory 2000, Val. 1)
Respiratory sensitisation
Endpoint conclusion
- Additional information:
No information is available
Migrated from Short description of key information:
No information is available
Justification for classification or non-classification
In the LLNA, Laromer DPGDA was demonstrated to be a skin sensitizer.
The substance will therefore be classified as sensitizing (Category 1) according to GHS criteria.
There are no data available to classify DPGDA as a sensitizer of the respiratory tract.
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