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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
Study period:
1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to OECD guideline 406 and in accordance 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:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Remarks:
Not specified in the report.
Principles of method if other than guideline:
Following OECD guideline 406
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Oxaban E (BIOBANTM CS-1246 Antimicrobial)
- Physical state: Clear colorless liquid
- Storage condition of test material: Stored at room temperature throughout the study ina clear glass bottle.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not specified although noted to be obtained from a U.S.D.A.-approved supplier
- Age at study initiation:
- Weight at study initiation: 368 - 689 grams
- Housing: Housed individually in wire mesh suspension cages
- Diet (e.g. ad libitum): Purina guinea pig chow fed ad libitum
- Water (e.g. ad libitum): Tap water provided ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Standard conditions
- Humidity (%): Standard conditions
- Air changes (per hr): Standard conditions
- Photoperiod (hrs dark / hrs light): 12/12 cycle

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
water
Concentration / amount:
Induction:
5% Injection application
25% Tropical application

Challenge:
Tropical application: 1%

Rechallenge:
Tropical application: 0.2, 0.01 and 0.001%


50%(V/V)



Injection Application: 5%
Tropical application: 25%

Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Induction:
5% Injection application
25% Tropical application

Challenge:
Tropical application: 1%

Rechallenge:
Tropical application: 0.2, 0.01 and 0.001%


50%(V/V)



Injection Application: 5%
Tropical application: 25%

No. of animals per dose:
Twenty test animals, 10 niave controls, 10 vehicle controls, 10 positive controls, 10 naive positive controls, 8 animals for topical application screens, and 4 intradermal injection pilots were used during the course of the study.
Details on study design:
Twenty test animals, 10 naive controls, 10 vehicle controls, 10 positive controls, 10 naive positive controls, 8 animals for topical application screens, and 4 intradermal injection pilots were used during the course of the study.

Animals were recieved from a commercial supplier, and were quarantined for at least 4 days prior to use. They were housed singly in wire caging, and were provided water and a commercial diet ad libitum. They were housed in rooms designed to maintain adequate environmental conditions for the species.

The study was conducted in 4 phases: irritation, intradermal induction, topical induction, and challenge. Irritation screens were accomplished by intradermally injecting varying concentrations of the test material in the selected solvent in paired rows on either side of the midline of the animal, or by applying the materials to a patch, and affixing the patch to the skin. Test sites were evaluated 24 hours later. The concentration selected for injection is one that does not cause tissue destruction, and is only mildly to moderately irritating. The challenge concentrations were no more than slightly irritating. Intradermal induction was accomplished by exposing the animals to a solution of the test material (or positive or negative control) and Freunds Complete Adjuvant (FCA). Volumes of 0.1mL were delivered to a cleanly-shaven test site in two rows of three injections on either side of the midline. Eight days later, topical inductions were performed by adding the materials to the patch, and covering for 48 hours. The wrappings were removed, skin sites cleaned and evaluated. Primary topical challenge was conducted 11-15 days after the topical induction in the same manner. Wrappings were removed after 24 hours, and sites evaluated. Six days after the first challenge, some animals may be challenged a second time in the same manner as the first topical challenge.
Challenge controls:
None
Positive control substance(s):
yes
Remarks:
Formaldehyde 5% w/v in distilled water

Study design: in vivo (LLNA)

Concentration:
Not applicable
No. of animals per dose:
Not applicable
Details on study design:
Not applicable
Statistics:
Primary irritation skin grades were used to derive at the toxicity data.

Results and discussion

Positive control results:
Positive control produced a 100% sensitization rate.

In vivo (LLNA)

Resultsopen allclose all
Parameter:
SI
Remarks on result:
other: Not applicable
Parameter:
other: disintegrations per minute (DPM)
Remarks on result:
other: Not applicable

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
sensitising
Remarks:
Migrated information
Conclusions:
The test material is considered to be a sensitizer in this system.
Executive summary:

Twenty test animals, 10 niave controls, 10 vehicle controls, 10 positive controls, 10 naive positive controls, 8 animals for topical application screens, and 4 intradermal injection pilots were used during the course of the study.

Animals were recieved from a commercial supplier, and were quarantined for at least 4 days prior to use.
 They were housed singly in wire caging, and were provided water and a commercial diet ad libitum. They were housed in rooms designed to maintain adequate environmental conditions for the species.

The study was conducted in 4 phases: irritation, intradermal induction, topical induction, and challenge.
 Irritation screens were accomplished by intradermally injecting varying concentrations of the test material in the selected solvent in paired rows on either side of the midline of the animal, or by applying the materials to a patch, and affixing the patch to the skin. Test sites were evaluated 24 hours later. The concentration selected for injection is one that does not cause tissue destruction, and is only mildly to moderately irritating. The challenge concentrations were no more than slightly irritating. Intradermal induction was accomplished by exposing the animals to a solution of the test material (or positive or negative control) and Freunds Complete Adjuvant (FCA). Volumes of 0.1mL were delivered to a cleanly-shaven test site in two rows of three injections on either side of the midline. Eight days later, topical inductions were performed by adding the materials to the patch, and covering for 48 hours. The wrappings were removed, skin sites cleaned and evaluated. Primary topical challenge was conducted 11-15 days after the topical induction in the same manner. Wrappings and excess test material were removed after 24 hours, and sites evaluated. Six days after the primary challenge, some animals were challenged a second time in the same manner as the first topical challenge.

The induction/challenge test at 0.001% was considered to have elicited a mild sensitization response.

The induction/challenge test at 0.01% was considered to have elicited a moderate sensitization response.

The induction/challenge test at 0.2% was considered to have elicited a strong sensitization response.

The induction/challenge test at 1% was considered to have elicited an "extreme" sensitization response.

Distilled water elicited a 0% sensitization rate, while the positive control produced a 100% sensitization rate.

The test material was determined to be a dermal sensitizer in guinea pigs.