Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
13. November to 15 December. 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to EU test guidance in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Version / remarks:
84/449/EWG, B.6 (Magnusson-Kligman-Test)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Reaktiv-Rot F-66813 FW

In vivo test system

Test animals

Species:
guinea pig
Strain:
Pirbright-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Weight at study initiation: 264 to 364 g
- Housing: 5/cage
- Diet: Altromin 3112 guinea pig maintenance diet ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 13-Nov To: 15-Dec-1989

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal: 5 % in 0,9 % NaCl-solution
b) Dermal: 5 % in 0,9 % NaCl-solution
Concentration of test material and vehicle used for each challenge: a) 5 % in 0,9 % NaCl-solution
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
Concentration of test material and vehicle used at induction:
a) Intradermal: 5 % in 0,9 % NaCl-solution
b) Dermal: 5 % in 0,9 % NaCl-solution
Concentration of test material and vehicle used for each challenge: a) 5 % in 0,9 % NaCl-solution
No. of animals per dose:
Determination of primary non-irritating concentration: 6
Determination of the intradermal tolerance: 3
Number of animals in attending group: 5
Number of animals in test group: 10 Number of animals in negative control group: 5
Details on study design:
RANGE FINDING TESTS:
- Determination of primary non-irritating concentration: dermal-occlusive exposure for 24 hours - 3 concentrations (25%, 5%, 1%)
- Determination of the intradermal tolerance: intradermal injection: 2 x 3 concentrations (5%, 1%, 0.2%)

MAIN STUDY
A. INTRADERMAL INDUCTION
- No of Injections: 2 x 3 preparations: 50% FCA, TS in 0.9% NaCl, TS in 50% FCA - treatment group
50% FCA, 0.9% NaCl, 50% FCA - control and attending group
- Exposure period: Injection on Day 1, observation Day 1 to Day 8
- Site: shoulder

B. DERMAL INDUCTION EXPOSURE
- No. of exposures: one
- Exposure period: 48 hours
- Test groups: TS in 0.9% NaCl
- Control group: 0.9% NaCl
- Site: shoulder
- Frequency of applications: single
- Duration: Day 8 to Day 22
- Concentrations: 5%

C. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: 22 (15 for attending group)
- Exposure period: 24 hours
- Test groups: TS + water
- Control group: TS + 0.9% NaCl
- Site: right flank: TS; left flank: 0.9% NaCl
- Concentrations: 5%
- Evaluation (hr after challenge): 24 and 48 hours
Challenge controls:
In addition to the control group, 5 further guinea pigs (attending group) were used to confirm that challenge exposure with 5% TS would not lead to dermal irritation in animals pre-treated with 50% FCA.
Positive control substance(s):
yes
Remarks:
bi-annual validation of assay

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
skin slightly reddish stained by TS
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: skin slightly reddish stained by TS.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
5%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
skin slightly reddish stained by TS
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: skin slightly reddish stained by TS.
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
skin slightly reddish stained by TS
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: skin slightly reddish stained by TS.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
5%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
skin slightly reddish stained by TS
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 5%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: skin slightly reddish stained by TS.

Any other information on results incl. tables

Signs of irritation during induction:
Administration of test substance in physiological saline solution led to reddening and edema at the adminstration site. All test substance treated sites were reddish stained by the test compound.


Evidence of sensitisation of each challenge concentration: none

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information not classified
Conclusions:
There was no evidence of a positive reaction in animals after challenge treatment with Reaktiv-Rot F-66813 FW in the present study.
According to the classification criteria of Directive 83/467/EEC, Reaktiv-Rot F-66813 FW is not sensitizing in the guinea pig maximization test and therefore not subject to labelling requirements.
Executive summary:

The skin sensitizing potential of Reaktiv-Rot F-66813 FW was examined in Pirbright-White guinea pigs with the maximization test.

Intradermal and dermal induction as well as the dermal challenge treatment were performed using 5% Reaktiv-Rot F-66813 FW in 0.9% NaCl.solution.

Based on the results of the present study, Reaktiv-Rot F-66813 FW is not sensitizing and not subject to labelling requirement.