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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes (incl. QA statement)
Type of study:
Buehler test
Justification for non-LLNA method:
The in vivo study data were obtained in studies performed before any in vitro sensitization tests tests had been validated and accepted for regulatory purposes.

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium toluene-4-sulphonate
EC Number:
211-522-5
EC Name:
Sodium toluene-4-sulphonate
Cas Number:
657-84-1
Molecular formula:
C7H7O3S.Na
IUPAC Name:
4-methylbenzenesulfonic acid

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Dunkin Hartley, Pirbright White
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Harlan Winkelmann GmbH, Versuchstierzucht, Borchen, Germany- Age at study initiation: young adults, no further details mentioned- Weight at study initiation: 317 ± 21 g- Housing: conventional, Makrolon Type IV cages (maximum 5 animals per cage) - Diet (e.g. ad libitum): Ssniff G4 complete feed for guinea pigs ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany- Water (e.g. ad libitum): drinking water ad libitum, supplied by Gelsenwasser, Wasserwerk, Haltern, Germany- Acclimation period: at least 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 22 ± 3- Humidity (%): 30 - 70- Air changes (per hr): 15 - Photoperiod (hrs dark / hrs light): 12/12IN-LIFE DATES: From: 1995-03-06 To: 1995-03-09 (preliminary study) From: 1995-03-20 To: 1995-04-20 (main study)

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
induction: 42.79 % (delivery form)challenge: 42.79 % (delivery form)
Challenge
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
induction: 42.79 % (delivery form)challenge: 42.79 % (delivery form)
No. of animals per dose:
test animals: 20 (main experiment), 3 (pilot study), 3 (determination of challenge concentration) control animals: 10
Details on study design:
RANGE FINDING TESTS: Determination of the non-irritant concentration of the test substance with occlusive epicutaneous applications for 6 hours of test substance 5%, 10%, 20% in deionized water and 42.79% (delivery form). Reading at 30 and 54 hours after application. Redetermination of the maximum non-irritant concentration for the challenge treatment in the 4th week with 3 additional guinea pigs which had not been treated up to this time. The concentrations and test conditions were the same as in the pilot study. This additional testing was carried out because it was suspected that the sensitivity of the skin changed as the weight of the animals increased. This ensured that the challenge concentration was determined on animals which had approx. the same weights as the 30 animals in the challenge phase.

MAIN STUDY

A. INDUCTION EXPOSURE- No. of exposures: 3- Exposure period: occlusive dermal applications for 6 hours, scoring at 30 hours after start of application- Test group: receiving test substance (0.3 cm³/patch)- Control group: receiving vehicle (0.3 cm³/patch)- Site: left flanks- Frequency of applications: induction on days 0, 7 and 14- Duration: 3 weeks- Concentrations: 42.79% (delivery form)

B. CHALLENGE EXPOSURE- No. of exposures: 1- Day(s) of challenge: on day 28- Exposure period: occlusive dermal application for 6 hours- Test groups: receiving test substance solution and vehicle (0.3 cm³/patch each)- Control group: receiving test substance solution and vehicle (0.3 cm³/patch each)- Site: right flanks (front: vehicle, back: test substance solution)- Concentrations: 42.79% (delivery form)- Evaluation (hr after challenge): 24 and 48 hours
Challenge controls:
same treatment as test group animals
Positive control substance(s):
yes
Remarks:
2-Mercaptobenzothiazole

Results and discussion

Positive control results:
The sensitivity of the used guinea pig strain was checked from 1994-11-07 to 1994-12-02. The test compound was used as an well-known standard allergen. The maximisations method was carried out for this test. A test goup of 10 and a control group of 5 animals were used to test the sensitivity. 48 and 72 hours after challenge treatment all skin reaction were recorded: Dermal irritation was found on the right flank of 9 of 10 test animals 48 and 72 hours after treatment with the allergen. Treatment of the test animals with the vehicle on the left flank likewise resulted in a slight or to distinct subcutaneous reaction after 48 and 72 hours in two animals.There were no signs of irritation at these times on the skin on the left (standard allergen) and right (vehicle) flanks of the control animals.It was necessary to pretreat the skin with 10% sodium dodecylsulphate in vaseline in order to cause slight to moderate cutaneous inflammation, because the highest allergen concentration which could be administered satisfactorily caused no dermal irritation.On the basis of these results (90% of test animals showed evidence of delayed contact hypersensitivity), the guinea pig strain was judged to be sensitive under the test conditions described. In the maximisation method, a figure of 30% or more is regarded as positive result.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
42.79%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no clinical effects observed
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 42.79%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no clinical effects observed.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
42.79%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no clinical effects observed
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 42.79%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no clinical effects observed.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
42.79%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no clinical effects observed
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 42.79%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no clinical effects observed.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
42.79%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no clinical effects observed
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 42.79%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no clinical effects observed.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Remarks on result:
no indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Remarks on result:
no indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
positive indication of skin sensitisation
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
positive indication of skin sensitisation

Any other information on results incl. tables

RESULTS OF PILOT STUDY

No irritant effects at any concentration of the test substance tested.

RESULTS OF TEST

- Sensitisation reaction: No sensitising effects observed.

- Clinical signs: No clinical effects observed. Body weight increase comparable to control.

Applicant's summary and conclusion

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

The skin sensitization potential of Sodium toluene 4-sulphonate was assessed following official guideline OECD 406, Skin sensitization. In this test Guinea pigs are treated by intradermal injection in the shoulder region to induce sensitization and 7 days later the sensitizationis boosted by an occluded patch placed over the injection site. 14 days later the animals are challengedon the flank by occluded patch. There action site is examined 24 hours and 48 hours after removal of the patch. No animals showed a challenge reaction at 24 or 48 hours, therefore the tested substance is considered to be non skin sensitizer.