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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
migrated information: read-across based on grouping of substances (category approach)
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

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Remarks:
lower number of test animals
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test

Test material

Constituent 1
Reference substance name:
4-toluene-sulphonic acid
IUPAC Name:
4-toluene-sulphonic acid
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
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
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 chemical
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.

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.