Registration Dossier
Registration Dossier
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EC number: 932-051-8 | CAS number: -
Toxicological information
Skin sensitisation
Currently viewing:
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1995-03-06 to 1995-04-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- 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
Test material
- Reference substance name:
- Sodium toluenesulphonate
- EC Number:
- 235-088-1
- EC Name:
- Sodium toluenesulphonate
- Cas Number:
- 12068-03-0
- IUPAC Name:
- sodium 4-methylbenzenesulfonate
- Details on test material:
- - Name of test material (as cited in study report): Na-toluolsulfonat
- Physical state: liquid
- Storage condition of test material: in a tightly closed container under hood
- Expiration date of the lot/batch: > 1 year (date of production: 1994-10-27)
Constituent 1
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 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-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)
Inductionopen allclose all
- Route:
- epicutaneous, occlusive
- Vehicle:
- water
- Concentration / amount:
- induction: 42.79 % (delivery form)
challenge: 42.79 % (delivery form)
Challengeopen allclose all
- 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.
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:
- not sensitising
- Remarks:
- Migrated information
- Conclusions:
- The test substance sodium toluenesulphonate showed no sensitizing effect on guinea pig skin under the described test conditions.
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