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Diss Factsheets

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:
other: GLP laboratory study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test already existing perior to the preparation of this dossier

Test material

Constituent 1
Reference substance name:
Branched CaDDBS
IUPAC Name:
Branched CaDDBS
Details on test material:
Calcium bis(tetrapropylenebenzenesulphonate); CAS No. 11117-11-6

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoeschst AG, Kastengrund, SPF breeding colony
- Age at study initiation: Not stated
- Weight at study initiation: Mean = 334 g
- Housing: Makrolon Type 4 cages on soft wood granulate in fullyl air-conditioned rooms in groups of 5 animals
- Diet (e.g. ad libitum): ad libitum, Altromin 3112 diet for guinea pigs and rabbits
- Water (e.g. ad libitum): ad libitum, tap water in plastic bottles
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 C
- Humidity (%): 55 +/- 20%
- Air changes (per hr): Not stated
- Photoperiod (hrs dark / hrs light): 12:12 dark:light

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: semi-liquid paraffin
Concentration / amount:
Intradermal induction was performed using 0.2% Phenylsulfonat CA in semi-liquid paraffin. Dermal induction were carreid out with 3% Phenylsulfonat CA in petrolatum. 0.1% Phenylsulfonat CA in petrolatum was selected for challenge treatment.
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: semi-liquid paraffin
Concentration / amount:
Intradermal induction was performed using 0.2% Phenylsulfonat CA in semi-liquid paraffin. Dermal induction were carreid out with 3% Phenylsulfonat CA in petrolatum. 0.1% Phenylsulfonat CA in petrolatum was selected for challenge treatment.
No. of animals per dose:
10 animals in the treatment group and 5 animals in the control group were used.
Details on study design:
Chronlogical description of the test procedure indicating the day at which the procedure was carried out:

Day 0: The body weights of the animals were determined. Guinea pigs were shaved mechanically over a dorsal area of 4x6 cm in the vicinity of the shoulders.

Day 1: Intradermal induction treatment: Two intradermal injections per animal of the following preparations. Injection sites 1, 2 and 3 were all within the dorsal area of 2 x 4 cm and were left uncovered.

Treated group:
Site 1: 2 x 0.1 mL of 50% Freund's adjuvant
Site 2: 2 x 0.1 mL of 0.2% solution of test substance in semi-liquid paraffin
Site 3: 2 x 0.1 mL of 0.2% solution of test substance in 50% Freund's adjuvant

Control and escort groups:
Site 1: 2 x 0.1 mL of 50% Freund's adjuvant
Site 2: 2 x 0.1 mL of semi-liquid paraffin
Site 3: 2 x 0.1 mL of 50% Freund's adjuvant

Days 1-7: The application area was examined for local tolerance. Any systemic toxic effects were recorded.

Day 8: Dermal induction treatment: 0.5 g of test substance preparation or the vehicle was applied to a 2 x 4 cm cellulose patch, which covered the area where intradermal injection had been made. The application area was kept for 48 hours under an occlusive bandage with an impermeable film and an elastic bandage.

Treatment group: 3% test substance in petrolatum
Control and escort group: petrolatum

Day 10: Occlusive bandage removed and irritant effects recorded.

Days 11-21: No treatment of control or treated group. Test animals kept under observation.

Days 15-18: Challenge treatment of escort group carried out in same way as that of control and treated groups (see days 22-25). Escort group (left flank): 1% Phenylsulfonat CA in petrolatum

Day 22: Dermal challenge treatment: One area of approximately 5 x 5 cm on the left flank was shaved mechanically. 0.5 g of the test substance preparation was applied to a 2 x 2 cm cellulose patch. The application area was then kept for 24 hours under an occlusive bandage with an impermeable film and an elastic bandage. Treated and control groups (left flank): 0.1% Phenylsulfonat CA in petrolatum.

Day 23: Occlusive bandage removed.

Day 24: Skin examined.

Day 25: Skin examined and body weights of test animals determined.
Challenge controls:
See details of study design.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: not available
Group:
test chemical
Dose level:
0.2% induction in semi-liquid paraffin
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No signs of irritation at 24 or 48 hours after removal of the occlusive bandage
Remarks on result:
other: Reading: other:. Clinical observations: No signs of irritation at 24 or 48 hours after removal of the occlusive bandage.
Reading:
other: not available
Group:
negative control
Remarks on result:
other: Data on the negative control is not available
Reading:
other: not available
Group:
positive control
Remarks on result:
other: Data on the positive control is not available

Any other information on results incl. tables

No signs of irritation were observed in the control and treatment groups 24 and 48 hours after removal of the occlusive bandage. No adverse effects on body weight gains were observed. The treated animals showed no clinical signs of intoxication throughout the study.

The intradermal injections with Freund's adjuvant (with and without test substance) casused severe erythema and oedema, indurations and encrustations. The application sites treated with the test substance showed very slight to well-defined erythema and very slight to slight oedema. Injections of the vehicle alone did not cause any sign of irritation. Due to these strong irritation reactions of the skin, 10% sodium dodecylsulfate was not applied at day 7.

After the removal of the patch at day 10, erythema and oedema, indurated adn encrusted skin as well as necrosis were observed at the application sites treated with Freund's adjuvant (with and without test substance). Additionally, the sites treated with test substance in Fruend's adjuvant exhibited open wounds in some cases. Very slight to well-defined erythema occurred at the application sites treated with the test substance in the vehicle.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance showed no evidence of sensitisation.
Executive summary:

Testing for sensitising properties of Phenylsulfonat CA was performed in female Guinea pigs according to OECD Guideline 406 methods (Guinea pig maximization test). Intradermal induction was performed using 0.2% Phenylsulfonat CA in semi-liquid paraffin. Dermal induction was carried out with 3% Phenylsulfonat CA in petrolatum. 0.1% Phenylsulfonat CA in petrolatum was selected for the challenge treatment. Results show no evidence for sensitisation. Phenylsulfonat CA is therefore not a dermal sensitiser.