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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

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Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1.11.1988-9.12.1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: A GLP study with good documentation but with fewer test animals than specified by guideline
Justification for type of information:
Grouping of structurally similar substances (category approach)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Remarks:
lower number of test animals
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Historic in vivo test
Species:
guinea pig
Strain:
other: Pirbright
Sex:
female
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
intradermal induction: 0.2%
topical induction: 20%
topical challenge: 10%
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
intradermal induction: 0.2%
topical induction: 20%
topical challenge: 10%
No. of animals per dose:
10 females in test group and 5 females in control group
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
10% in saline solution
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no positive response
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% in saline solution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no positive response.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
10% in saline solution
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no positive response
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10% in saline solution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no positive response.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% in saline solution
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no positive response
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% in saline solution. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no positive response.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
10% in saline solution
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no positive response
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 10% in saline solution. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no positive response.
Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
None of the tested animals showed positive responses. The test substance can be considered a non-sensitizer in guinea pigs.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

There is a single, key study for sensitization of the aromatic sulphonic acids. None of the tested animals showed positive responses in a, well documented, GLP guinea pig sensitization study (Hoechst, 1988) with toluene-4-sulphonic acid (CAS No. 104-15-4). The test substance can be considered a non-sensitizer in guinea pigs as none of the test animals showed a positive response to combined intradermal and topical induction followed by topical challenge

Migrated from Short description of key information:

Not sensitizing

Justification for classification or non-classification

There is no human or animal evidence on this endpoint therefore no classification is warranted under 67/548/EEC or Regulation 1272/2008.