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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:
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.