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EC number: 296-719-4
CAS number: 93028-28-5
Table 1: PRELIMINARY IRRITATION STUDY
SKIN REACTIONS AFTER EPIDERMAL EXPOSURE
24 hours after exposure
48 hours after exposure
Table 2: INDUCTION AND CHALLENGE READINGS
24 Hour Readings
48 Hour Readings
#. Test substance concentration (experimental animals) or vehicle
Vehicle: Kaydol White Mineral Oil.
Table 3: BODYWEIGHTS (GRAM)
Assessment of Contact Hypersensitivity to 93820-55-4 Benzenesulfonic
Acid, di C10-18-alkyl derivs barium salts, neutral, in diluents oil and
TBN = <10 in the Albino Guinea Pig (Buehler Test).
The study was carried out based on the guidelines and test method
OECD No. 406 (1992), "Skin Sensitization"
EC No 440/2008; B6: "Skin Sensitization: Buehler Test”.
EPA OPPTS 870.2600 (2003) “Skin Sensitization”
JMAFF: Japanese Test Guidelines (2000) including the most recent partial
The Buehler type of sensitization test is selected at the request of the
sponsor since this substance is a surfactant. Studies have shown that
the preferred sensitization test (Local Lymph Node Assay) over predicts
sensitization potential of these substances
Test substance concentrations selected for the Main study were based on
the results of a preliminary study.
In the Main study, twenty experimental animals were epidermally treated
on three occasions (Days 1, 8 and 15) with the undiluted test substance
and ten control animals were similarly treated, but with vehicle alone
(Kaydol white mineral oil). Two weeks after the last induction exposure,
all animals were challenged with the undiluted test substance.
RESULTS: In the challenge phase, skin reactions of grade 1 were observed
in seven experimental animals in response to the undiluted test
substance. No skin reactions were evident in the control animals.
Scaliness was seen in two of the experimental animals with grade 1 skin
CONCLUSION: The skin reactions observed in response to the undiluted
test substance in seven of the twenty (35%) experimental animals in the
challenge phase were considered indicative of sensitization, based on
the ≥ 15% criteria for evidence of skin sensitisation and the absence of
any response in the control animals.
As determined by ECHA guidance in Appendix R. 8 -11, and considering
that no data from use of the substance are available, it is not possible
to assess respiratory sensitisation or estimate a threshold or DNEL. It
is known, nonetheless, that some, but not all, skin sensitisers can also
cause respiratory sensitisation.
Migrated from Short description of key information:
Respiratory sensitisation has not been assessed. There are currently no
validated in vitro or in vivo data and no data available from human
exposure (e.g. workers) to demonstrate or deny respiratory senitisation.
Based on the available animal that all show positive results
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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