Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin sensitisation

Currently viewing:

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:
study well documented, meets generally accepted scientific principles, acceptable for assessment

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
Principles of method if other than guideline:
Acceptable method
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was already existing

Test material

Constituent 1
Reference substance name:
p-toluenesulfonic acid
IUPAC Name:
p-toluenesulfonic acid
Constituent 2
Chemical structure
Reference substance name:
Toluene-4-sulphonic acid
EC Number:
203-180-0
EC Name:
Toluene-4-sulphonic acid
Cas Number:
104-15-4
Molecular formula:
C7H8O3S
IUPAC Name:
4-methylbenzene-1-sulfonic acid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright
Sex:
female
Details on test animals and environmental conditions:
Supplier: Hoechst AG, Kastengrund, SPF-Zucht
Weight: 310-394 g
Housing: Makrolon cages (type 4), Weichholz-granulate bedding, 5 animals per cage, air conditioned system
Temperature: 22 ± 3 °C
Relative Humidity: 50 ± 20 %
Phot period: 12h/12h
Food: ad libitum feed for animals (Supplier: ERKA- Mishfutter Nr. 8300)
Water: ad libitum, tap water
Acclimation: 5 days



Study design: in vivo (non-LLNA)

Induction
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
0.2 %
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Challenge
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
10 %
Adequacy of challenge:
not specified
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
Group:
positive control
Remarks on result:
positive indication of skin sensitisation
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.

Any other information on results incl. tables

See attached tables for details.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Not skin sensitizer
Executive summary:

The skin sensitization potential of Toluene 4-sulphonic acid was assessed following official EU Method B.6, Skin sensitization. None of the tested animals showed positive responses and the test substance can be considered a non-sensitizer in guinea pigs.