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Toxicological information

Skin sensitisation

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Administrative data

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:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
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:
Historical test that pre-dates REACH Regulation

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): p-Toluolsulfonsaure
- Substance type: organic
- Physical state: solid
- Analytical purity: >98%
- Isomers composition: p-isomer:84.6%; o-isomer: 10.6%; m-isomer: 4.6%
- Lot/batch No.: GPAD 185
- Expiration date of the lot/batch: no data
- Storage condition of test material: in dark at 20C

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright
Sex:
female

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
intradermal induction: 0.2%
topical induction: 20%
topical challenge: 10%
Challengeopen allclose all
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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
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.
Key result
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.
Key result
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.
Key result
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.
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

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.