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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
Study period:
12 August 2004 to 11 September 2004
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted under GLP in accordance with an internationally recognised test guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2004
Report date:
2004

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2600 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
A Guinea Pig Maximisation study result which pre-dates the OECD guideline for the LLNA is available and the study is considered to be of sufficient reliability to satisfy the data requirement. On this basis it is considered that a supplementary LLNA would not be appropriate.

Test material

Constituent 1
Reference substance name:
Terracess TF
IUPAC Name:
Terracess TF
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Terracess TF-L
- Appearance: white powder
- Purity: >99%
- Lot/batch No.: 040803-3D

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: Hartley albino
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: First induction phase - intradermal. Second induction phase - topical
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradermal induction 1% w/w mixture in distilled water
b) topical induction 70% w/w mixture in distilled water

Concentration of test material and vehicle used for each challenge:
70% w/w mixture of the test substance in distilled water



23% w/w mixture of the test substance in distilled water
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) intradermal induction 1% w/w mixture in distilled water
b) topical induction 70% w/w mixture in distilled water

Concentration of test material and vehicle used for each challenge:
70% w/w mixture of the test substance in distilled water



23% w/w mixture of the test substance in distilled water
No. of animals per dose:
Number of animals in test group: 20
Number of animals in negative control group: 10
Details on study design:
RANGE FINDING TESTS:
Prior to the induction phase, a group of four animals was used to determine the concentration of the test substance which produced faint to moderate irritation via intradermal injection. Each guinea pig received six intradermal injections (0.1 m1 each); three concentrations (1, 3, and 5%) of the test substance in distilled water and the same three concentrations in an emulsion of Complete Freund's Adjuvant.

Prior to the topical induction, a group of four animals was used to determine the irritation potential of the test substance to be used during the topical induction. The test substance was mixed with distilled water to yield w/w concentrations of 70%1 and 53% (75% of the dry paste concentration).

A group of four animals was used to determine the highest non-irritating concentration. The test substance was mixed with distilled water to yield w/w concentrations of 70%, 53%, 35% and 18%.

Based on these findings, the concentrations which produced very faint to faint irritation (0.5-1) for the intradermal induction were the 3% and 5% w/w mixtures in distilled water. However, due to the difficulty of injection at these concentrations a 1% w/w mixture was used. That which produced very
faint to faint irritation (0.5-1) selected for the topical induction was a 70% w/w mixture in distilled water with a pretreatment of sodium lauryl sulfate (SLS). The HNIC selected for the challenge phase was a 70% w/w mixture in distilled water.

MAIN STUDY
INDUCTION EXPOSURE (intradermal phase)
- No. of exposures: 6
- Exposure period: 48 hours
- Concentrations: i) 50% v/v mixture Complete Freund's Adjuvant in distilled water
ii) 1% w/w mixture of test substance in distilled water
iii)1% w/w mixture of test substance in 50% Complete Freund's Adjuvant in distilled water

INDUCTION EXPOSURE (topical phase)
- No. of exposures: 1
- Exposure period: 48 hours
- Concentrations: 0.5 g of a 70% w/w mixture of the test substance in distilled water

B. CHALLENGE EXPOSURE
- No. of exposures: 3
- Day(s) of challenge: challenge phase started on Day 21
- Concentrations: i) 0.5 g of a 70% w/w mixture of the test substance (HNIC) in distilled water
ii) 0.5 ml of a 23% w/w mixture (33% dilution of the HNIC)

- Evaluation (hr after challenge): 24 and 48 hours

Challenge controls:
0.5 ml of distilled water

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
70 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 70 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
23 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 23 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
70 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 70 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
23 %
No. with + reactions:
0
Total no. in group:
20
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 23 %. No with. + reactions: 0.0. Total no. in groups: 20.0.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
50 %
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 50 %. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU