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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:
1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was performed in 1988, prior to LLNA being the gold standard for sensitization testing. With regard to the good quality of the study, there is no scientific justification for the conduct of another sensitization study.

Test material

Constituent 1
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-methylbenzenesulfonic acid
Details on test material:
- product number: GPAD 185
- CAS number: 104-15-4
- appearance: grey to white, cristalline powder
- MW: 190.2 g/mol
- melting point: 98 °C
- decomposition temperature: approx. 170 °C
- solubility: readily in water
- pH in water: below 1
- imurities: 0.3% H2SO4
- purity: > 98 %
- storage: in the dark at room temperature under local exhaust ventilation

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF-Zucht
- strain: Hoe: DHPK(SPFLac)
- Weight at study initiation: approx. 351 g
- Housing: in groups (5 animals)
- Diet (e.g. ad libitum): ERKA-Mischfutter Nr. 8300 for guinea pigs and rabbits, ad libitum
- Water (e.g. ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Treatment group:
- intradermal induction: 0.2% in 0.9% physiol saline or in 50% Freud Adjuvant
- epidermal induction: 20% in 0.9% physiol saline
- challenge: 10% in 0.9% physiol saline

Control group:
- intradermal induction: 0.9% physiol saline or in 50% Freud Adjuvant
- epidermal induction: 0.9% physiol saline
- challenge: 10% in 0.9% physiol saline
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
Treatment group:
- intradermal induction: 0.2% in 0.9% physiol saline or in 50% Freud Adjuvant
- epidermal induction: 20% in 0.9% physiol saline
- challenge: 10% in 0.9% physiol saline

Control group:
- intradermal induction: 0.9% physiol saline or in 50% Freud Adjuvant
- epidermal induction: 0.9% physiol saline
- challenge: 10% in 0.9% physiol saline
No. of animals per dose:
10 (treatment) and 5 (control)

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
other: control group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: other: control group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.
Reading:
2nd reading
Hours after challenge:
72
Group:
other: control group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
5
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: other: control group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 5.0.

Any other information on results incl. tables

No signs of irritation after epidermal application of the test substance were noted using the 0.01%; 0.1%; 1%; 5%; and 10% concentrations, with and without Freud Adjuvant.

Applicant's summary and conclusion

Interpretation of results:
not sensitising