Registration Dossier

Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Justification for type of information:
JUSTIFICATION FOR READ-ACROSS FROM SUPPORTING SUBSTANCE (STRUCTURAL ANALOGUE OR SURROGATE)
For bromhydrin-valerate (CAS No. 54605-02-6) no skin sensitisation data in animals or humans are available. Therefore, human skin sensitisation data of diflucortolone-21-valerate (CAS No. 59198-70-8) were used since these data are regarded as representative. In diflucortolone-21-valerate the bromine atom in position 9 of the target molecule (bromhydrin-valerate) is replaced by a fluorine atom. No other changes in the molecule occured. No relevant toxicological effects are expected by the change of a halogen atom (Br) versus another (F). A search for structure-analogue substances using the QSAR OECD Toolbox 3.4 recommended diflucortolone-21-valerate as one out of 8 category substances for a read-across approach (for additional information see QSAR OECD Toolbox Report on Bromhydrin-valerat in "Attached justification").

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1994

Materials and methods

Type of sensitisation studied:
skin
Study type:
case report
Principles of method if other than guideline:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Results of examinations:
A patch test with diflucortolone valerate (TemetexR ointment) in a female patient with a budesonide allergy showed no reactions at D2, D3 and D4.

Applicant's summary and conclusion

Executive summary:

A 54-year old female patient with a budesonide allergy was patch tested to diflucortolone valerate (TemetexR ointment). No reactions were observed at D2, D3 and D4.