Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Jun 06 2000 - Jun 30 2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study was performed in compliance with the Good Laboratory Practice (GLP) regulations (revised in 1997, ENV/MC/CHEM(98)17). The method followed that described in the OECD Guidelines for Testing of Chemicals, Updated Guideline No 406 Skin Sensitisation (adopted 17 Julyl 1992).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Principles of method if other than guideline:
None
GLP compliance:
yes (incl. certificate)
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Chemical Name: CCP-V-1

In vivo test system

Test animals

Species:
guinea pig
Strain:
other: HsdPoc:DH
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
Harlan Winkelmann GmbH, Borchen, Germany

- Age at study initiation:
about 6 weeks (beginning of treatment)

- Weight at study initiation:
372 g (range from 316 g to 415 g)

- Housing:
single
Makrolon cage type with a shelter placed on mobile racks
bedding conventional softwood granulate
bedding change twice weekly

- Diet (e.g. ad libitum):
exclusive diet for guinea pigs No. 845, Eberle Nafag

- Water (e.g. ad libitum):
community tap water ad libitum from Makrolon drinking bottles

- Acclimation period:
At least 7 days prior to the start of dosing under test conditions after health examination.
The guinea pigs were identified by color mark.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-27 °C
- Humidity (%): 46-84 %
- Air changes (per hr): --
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
other: intradermal and topical
Vehicle:
paraffin oil
Concentration / amount:
Induction stage I: intradermal
Induction stage II: topical 5 g/L test material
challange 10 g/L: topical 10 g/L test material
Challengeopen allclose all
Route:
other: topical
Vehicle:
paraffin oil
Concentration / amount:
Induction stage I: intradermal
Induction stage II: topical 5 g/L test material
challange 10 g/L: topical 10 g/L test material
No. of animals per dose:
Total: 35 females
Pre-test: 5 females
Control group: 10 females (negative control)
Test group 20 females (test material)
Details on study design:
RANGE FINDING TESTS:
- intradermal injection: 0, 1, 5, 10, 25, 50 g/L given to one animal
- topical applications, no pretreatment: 1, 10, 50, 100, 200, 400 g/L given to four animals
- topical applications, pretreatment with FCA: 1, 5, 10, 25 g/L given to two animals

MAIN STUDY
A1. INDUCTION EXPOSURE (intradermal injection)
- No. of exposures: 6 injections of 0.1 ml each, three on each side of the spinal column)
- Test groups: 0.1 ml FCA + NaCl, 5g/L test item ad liquid paraffin, FCA + 5 g/L test item + NaCl
- Control group: 0.1 ml FCA + NaCl, 0.1 ml liquid paraffin, 0.1 ml FCA + NaCl
- Site: cranial, medial, caudal
- Frequency of applications: single
- Concentrations: 5 g/L

A2. INDUCTION EXPOSURE (topical application)
- No. of exposures: one week after injection (A1) single topical application of a filter plate soaked with either test solution, or vehicle
- Test groups: Test item (50 g/L) in liquid paraffin
- Control group: liquid paraffin
- Site: cranial, medial, caudal (8 cm^2)
- Frequency of applications: single
- Duration: 48 h, occlusive
- Concentrations: 50 g/L

B. CHALLENGE EXPOSURE
- No. of exposures: single
- Day(s) of challenge: 1d
- Exposure period: 2 weeks after topical application
- Test groups: 10 g/L test item
- Control group: liquid paraffin
- Site: cranial, medial, caudal (4 cm^2)
- Concentrations: 10 g/L
- Evaluation (hr after challenge): 48 and 72 h


Challenge controls:
Data from the GLP study with Experimental part: April 11 until May 05, 2000.
Positive control substance(s):
yes
Remarks:
Hexylcinnamaldehyde

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
48
Group:
test group
Dose level:
10 g/L
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no signs of toxicity
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10 g/L. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no signs of toxicity.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
10 g/L
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs of toxicity
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10 g/L. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of toxicity.
Reading:
2nd reading
Hours after challenge:
72
Group:
test group
Dose level:
10 g/L
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
no signs of toxicity
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10 g/L. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: no signs of toxicity.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
10 g/L
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no signs of toxicity
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 10 g/L. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no signs of toxicity.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Under the given experimental conditions, the test material induced no reactions. According to the Directive 2001/59/EC, the test material is not to be classified as a sensitizer.
Executive summary:

Purpose

The purpose of this assay was to identify the contact allergenic potential of CCP-V-1 in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969). This study should provide a rational basis for risk assessment to the sensitising potential of the test item in man.

Study Design

The test item as investigated for skin sensitizing properties in the guinea pig maximization test according to MAGNUSSON and KLIGMAN (1969). 10 females were treated with the vehicles liquid paraffin (group 1) and 20 females were treated with the test material (group 2). The induction included intradermal injection of test material preparation in liquid paraffin (5 g/L with and without Freund's complete adjuvant) on experimental day 1, and topical application of test material preparation in liquid paraffine (50 g/L) for 48 hours on experimental day 8. The challenge was performed by topical application of the test material preparation (10 g/L) for 24 hours, two weeks after topical induction and readings were taken at 48 hours and 72 hours after start of treatment.

Results

After challenge no positive reactions were seen 48 or 72 hours after treatment with the test material.

Conclusions

Under the given experimental conditions, the test material induced no reactions. According to the Directive 2001/59/EC, the test material is not to be classified as a sensitizer.