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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin sensitisation

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Administrative data

skin sensitisation: in vitro
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is performed according to GLP according to a standardized and validated produre.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
no guideline available
Principles of method if other than guideline:
Peptide reactivity determined by incubation with two model peptides and HPLC-analysis of peptide concentration.
GLP compliance:
yes (incl. QA statement)
Type of study:
other: Peptide-binding assay (DPRA)

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1-amino-4-bromo-9,10-dioxoanthracene-2-sulphonate
EC Number:
EC Name:
Sodium 1-amino-4-bromo-9,10-dioxoanthracene-2-sulphonate
Cas Number:
Molecular formula:
sodium 1-amino-4-bromo-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate
Details on test material:
- Name of test material (as cited in study report): Bromaminic acid sodium salt
- Substance type: no data
- Physical state: no data
- Analytical purity: given as 100% , analytical characterization ongoing
- Purity test date: 2012
- Lot/batch No.: 0005790051
- Expiration date of the lot/batch: 14 Dec 2013
- Stability under test conditions: stable (indicated by sponsor)
- Storage condition of test material: no data
-Other: The test substance was homogeneous by visual inspection.

In vivo test system

Test animals

other: not applicable
other: not applicable

Study design: in vivo (non-LLNA)

Positive control substance(s):
Ethylene glycol dimethacrylate

Results and discussion

Positive control results:
Ethylene glycol dimethacrylate was used as positive control. It caused a mean peptide depletion of 24%.

Any other information on results incl. tables

The mean K-peptide depletion, caused by the test substance was determined to be 99.0%.

The mean C-peptide depletion, caused by the test substance was determined to be 10.1% in the first test run and 5.8% in the second evaluable test run. Hence, the mean C-peptide depletion was detrmined to be 8.0%.

Thus, the mean peptide depletion was calculated to be 53.5%.

No co-elution of test substance and peptides was noticed.

Based on the observed results and applying the prediction model proposed in Gerberick et. al (2007) it was concluded that Bromaminic acid sodium salt shows a high protein binding reactivity in the DPRA under the test conditions chosen.

Applicant's summary and conclusion

Interpretation of results:
other: The substance binds to peptides in vitro.
Executive summary:

Depletion of the Cystein-Peptide was 5,8%; depletion of the Lysin-Peptide was 99%. Therefore, the substance shows strong peptide-binding reactivity.