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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:
22 December 2008 to 15 January 2009
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study undertaken at GLP accredited laboratory to internationally recognised guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

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

Test material

Constituent 1
Reference substance name:
ECOPROMOTE
IUPAC Name:
ECOPROMOTE
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report):ECOPROMOTE
- Substance type: inorganic
- Physical state: powder
- Analytical purity: 99%
- Lot/batch No.: 7279
- Storage condition of test material: Room temperature and dark storage
- Other: date of receipt December 09 2008.

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Commercial laboratory animal supplier.
- Age at study initiation: 4 weeks
- Weight at study initiation: 278 to 292 g
- Housing: Stainless steel cages
- Diet (e.g. ad libitum): The animals could freely access pellet food RC4 (Lot No. 081I1I, Oriental Yeast Co., Ltd.)
- Water (e.g. ad libitum): Tap water supplied by the local government was filtered through a 5-1J.Dl cartridge filter and was offered ad libitum from the automatic watering system.
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 21.4 to 24.2°C
- Humidity: 43.6 to 62.6%
- Air changes: 17 air changes / hr
- Photoperiod (hrs dark / hrs light): Artificial lighting, with a sequence of 12 hours on (between 6:00 a.m. and 6:00 p.m.) and 12 hours off

IN-LIFE DATES: From: 22 December 2008 To: 14 January 2009

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
paraffin oil
Concentration / amount:
Induction;

for intradermal induction of sensitization, 0.1 mL each of the following formulations were injected to 2 sites in the neck of each animal: A, an emulsion of equal volumes of Freund's complete adjuvant (PCA) and physiological saline; B, a 0.3 w/v% test substance formulation (vehicle: liquid paraffin); C, an emulsion of equal volumes of a 0.6 w/v% test substance formulation (vehicle: FCA) and physiological saline.

For induction of sensitization by direct contact, a 2 x 4-cm piece of lint impregnated with 0.2 mL of a 40 w/v% the test substance formulation (vehicle: liquid paraffin) was applied to the intradermal injection sites on Day 7 and close contact was maintained for 48 hours.


For challenge, on Day 21 after the start of induction of sensitization, the cloth of an adhesive tape for patch tests impregnated with 0.1 mL of 40, 10, 3, 1, 0.3 or' 0.1 w/v% test substance formulation. (vehicle: liquid paraffin) was applied directly to the lateral . abdominal region ofeach animal and close con.tact was maintained for 24 hours.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
paraffin oil
Concentration / amount:
Induction;

for intradermal induction of sensitization, 0.1 mL each of the following formulations were injected to 2 sites in the neck of each animal: A, an emulsion of equal volumes of Freund's complete adjuvant (PCA) and physiological saline; B, a 0.3 w/v% test substance formulation (vehicle: liquid paraffin); C, an emulsion of equal volumes of a 0.6 w/v% test substance formulation (vehicle: FCA) and physiological saline.

For induction of sensitization by direct contact, a 2 x 4-cm piece of lint impregnated with 0.2 mL of a 40 w/v% the test substance formulation (vehicle: liquid paraffin) was applied to the intradermal injection sites on Day 7 and close contact was maintained for 48 hours.


For challenge, on Day 21 after the start of induction of sensitization, the cloth of an adhesive tape for patch tests impregnated with 0.1 mL of 40, 10, 3, 1, 0.3 or' 0.1 w/v% test substance formulation. (vehicle: liquid paraffin) was applied directly to the lateral . abdominal region ofeach animal and close con.tact was maintained for 24 hours.
No. of animals per dose:
A total of 15 animals were used. The test groups consisted ofthe sensitization induction group receiving the test substance (10 animals) and its control group (5 animals).
Details on study design:
RANGE FINDING TESTS: this test substance was shown to be non-irritating when applied directly and close contact was maintained

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 21 days
- Test groups: 1
- Control group: 1
- Site: neck
- Frequency of applications: 1
- Duration: 21 days
- Concentrations: 0.3 to 0.6 % w/v

B. CHALLENGE EXPOSURE
- No. of exposures: 6
- Day(s) of challenge: 21d
- Exposure period: 1 day
- Test groups: 1
- Control group: 1
- Site: abdomen
- Concentrations: 40, 10, 3, 1, 0.3 or 0.1 w/v%
- Evaluation (hr after challenge): 24 and 48 hours

Challenge controls:
For challenge, on Day 21 after the start of induction of sensitization, the cloth of an adhesive tape for patch tests impregnated with 0.1 mL of 40, 10, 3, 1, 0.3 or' 0.1 w/v% test substance formulation. (vehicle: liquid paraffin) was applied directly to the lateral . abdominal region ofeach animal and close con.tact was maintained for 24 hours. Skin reactions were evaluated 24 and 48 hours after removal of the patches applied for
challenge.
Positive control substance(s):
no

Results and discussion

Positive control results:
No data

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.3 to 0.6 % w/v
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.3 to 0.6 % w/v. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
24
Group:
test chemical
Dose level:
40, 10, 3, 1, 0.3 or' 0.1 w/v%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 40, 10, 3, 1, 0.3 or' 0.1 w/v%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
40, 10, 3, 1, 0.3 or' 0.1 w/v%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
None
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 40, 10, 3, 1, 0.3 or' 0.1 w/v%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: None.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of this study, it was concluded that this test substance had no sensitization potential.

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