Registration Dossier
Registration Dossier
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EC number: 206-058-5 | CAS number: 298-12-4
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (sensitising)
- Additional information:
- In a dermal sensitisation study with Glyoxylic Acid 50% in acetone, 8 - 12
weeks old female Balb/c mice were tested using a combined Local Lymph Node
Assay. The test concentrations were 1.25 , 2.5, 5.0, 10 , 20 or 40 %.
Signs of skin irritation were seen at 40%. Glyoxylic Acid 50% tested
positive in the LLNA with an EC3 value of 5.05% and a maximal stimulation
index of 23.9 achieved at the 40% test concentration. Significant
increases were observed in the B220+ cell population in the draining lymph
nodes. No changes were identified in the IgE+B220+ cell population in the
draining lymph nodes or total serum IgE levels; this suggests that
Glyoxylic Acid 50% functions as a T-cell-mediated contact sensitizer
(Anderson SE, 2008). In a dermal sensitisation study with Glyoxylic Acid
in water young Pirbright white Guinea pigs (15 males) were tested using a
method similar to Freund's complete adjuvant test (Induction: 10
injections intracutaneous, Challenge 80 % epicutaneous, open). In this
study 100 % (15/15) of the animals treated with Glyoxylic acid showed a
skin sensitization response. In this study, Glyoxylic acid is a potent
dermal sensitiser (Hoechst, 1975).
Migrated from Short description of key information:
Glyoxylic acid was sensitising in the LLNA test and a guinea pig sensitisation test similar to Freund's complete adjuvant test.
Respiratory sensitisation
Endpoint conclusion
- Additional information:
- There are no human data available
indicative of a respiratory sensitisation. Lymph node phenotyping
performed in the LLNA published by Anderson (2008) suggested that the
Glyoxylic acid response is a TH1 rather than a TH2 response, indicating no
respiratory sensitising potential.
Migrated from Short description of key information:
There is no data available indicating a respiratory sensitising potential.
Justification for classification or non-classification
Based on the results of the sensitisation studies, Glyoxylic Acid 50% is subject to classification and labelling as follows:
R43 (may cause sensitisation by skin contact) according to Directive 67/548/EEC
Cat 1 / H317 ( may cause an allergic skin reaction) according to Regulation 1272/2008/EC.
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