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Toxicological information

Skin sensitisation

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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:
From September 26, 1994 to November 24, 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study conducted according to OECD Guideline 406 and EU Method B6, in compliance with GLP.
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
GLP compliance:
yes
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: Clear colourless liquid
- Analytical purity: 28.7%
- Composition of test material, percentage of components: ca. 30% cetrimonium chloride, ca. 70% water
- Lot/batch No.: E06178641, produced on 26-07-1993

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Pirbright-White
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, SPF breeding
- Weight at study initiation: 227 - 299 g (average 269 g)
- Housing: in groups of 5 in Type 4 macrolon cages
- Diet (e.g. ad libitum): Altromin diet for guinea pigs, Altromin GmbH, Lage/Lippe, Germany
- Water (e.g. ad libitum): tap water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23°C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12/12

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
For the determination of a non-irritating concentration: 0.1, 1.0, 4.0, 20.0 and 100.0% w/v
Dermal induction: 4% w/v
Challenge: 1% w/v
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
For the determination of a non-irritating concentration: 0.1, 1.0, 4.0, 20.0 and 100.0% w/v
Dermal induction: 4% w/v
Challenge: 1% w/v
No. of animals per dose:
20 for treated group
10 for controls
Positive control substance(s):
no

Results and discussion

Any other information on results incl. tables

Determination of a non-irritating concentration

Exposure of guinea pig skin to 100 or 20% w/v test substance resulted in moderate erythema and very light to light edema. At 4% w/v, the animals showed light / clearly defined erythema, and in one animal very light edema. There were no signs of irritation at 1 or 0.2% w/v.

The doses of 4 and 1% w/v were therefore selected for the induction and challenge phases, respectively.

Dermal induction phase

During the induction phase (Days 1 - 15), animals presented light to clearly defined erythema and very light edema. In the control group, no effects were seen on the treated skin.

Challenge phase

24 and 48 h after the occlusive bandage was removed, no effects were observed in any animals of the treated or control groups.

Clinical signs and bodyweight

During the main test, there were no signs of toxicity and bodyweight gain of the test animals was comparable to that of controls.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the Buehler test, the substance is considered to be non-sensitizing.
Executive summary:

An OECD guideline study was conducted to determine the sensitising potential of the read-across substance C16 TMAC (active ingredient 30%) in guinea-pigs according to the Buehler method. A pre-test was conducted to determine the non-irritating concentrations to use in the main study. During the induction phase (Days 1-15), the test animals were exposed to 0.5 mL of the test substance at 4% w/v via an occlusive bandage placed on the shaved skin of the left flank. After 6 hours, the bandage was removed and the skin was washed with warm tap water. Observations of the treated skin were made approximately 24 hours later. On Day 29, the test and control animals were exposed to 0.5 mL of the test substance at 1% w/v via an occlusive bandage placed on the shaved skin of the right flank. On Days 30 and 31, a macroscopic evaluation of the treated skin was made and animal bodyweights were recorded. During the dermal induction phase (Days 1-5), animals presented light to clearly defined erythema and very light edema. In the control group, no effects were seen on the treated skin. In the challenge phase, 24 and 48 hours after the occlusive bandage was removed, no effects were observed in any animals of the treated or control groups. During the main test, there were no signs of toxicity and bodyweight gain of the test animals were comparable to that of the controls. Under the conditions of the test, the substance was considered to be non-sensitising (Bury D, 1994).