Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Remarks:
- measurement of thickness of skin fold rather than observation of skin color
Qualifier:
according to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
- measurement of thickness of skin fold rather than observation of skin color
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
This study has been conducted when the LLNA was not yet the standard method.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Reactive Blue FC 15353

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Versuchstieranstalt Winkelmann, Borchen, Kreis Paderborn
- Age at study initiation: 5 - 8 weeks
- Weight at study initiation: 360 g (314 - 416 g)
- Housing: Makrolon-cages (type IV), on soft wood granulate in groups of 5 animals
- Diet (e.g. ad libitum): Altromin 3022, ad libitum
- Water (e.g. ad libitum): tap water in 2 750 mL plastic bottles, ad libitum
- Acclimation period: 7 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2 °C
- Humidity (%): 50%
- Air changes (per hr): 10-fold/h
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light (artificial lightning)

IN-LIFE DATES: From: To: Nov. 04, 1986 to Dec. 12, 1986

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
other: Cremophor EL (2% v/v) in water for injection purposes
Concentration / amount:
- intradermal injection: 0.5%
- dermal application 25%, 25% and 10%
Challengeopen allclose all
Route:
other: dermal
Vehicle:
other: Cremophor EL (2% v/v) in water for injection purposes
Concentration / amount:
- intradermal injection: 0.5%
- dermal application 25%, 25% and 10%
No. of animals per dose:
- test group: 20 animals
- 2 Control groups: 10 animals each

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Group:
test group
Dose level:
25%
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
none
Remarks on result:
other: Reading: 1st reading. Group: test group. Dose level: 25%. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: none.

Any other information on results incl. tables

1. Auslösung (25%ige Prüfmusterformu1ierung)

 

1.Kontrollgruppe

 

Prüfmusterseite

Kontrollseite

Prüfmusterseite

Kontrollseite

 

vor Behandl.

vor Behandl.

48h

72h

48h

72h

 

 

nach Behandlung

Hautfaltendicke in mm

 

 

 

 

 

 

M

1.57

1.49

1.83

1.80

1.65

1.62

S

0.14

0.13

0.11

0.13

0.10

0.11

 

Prüfmustergruppe

 

Prüfmusterseite

Kontrollseite

Prüfmusterseite

Kontrollseite

 

vor Behandl.

vor Behandl.

48h

72h

48h

72h

 

 

nach Behandlung

Hautfaltendicke in mm

 

 

 

 

 

 

M

1.58

1.49

1.85

1.84

1.61

1.58

S

0.10

0.09

0.14

0.13

0.12

0.10

M =Mittelwert

S=Standardabweichung

Behandl.=Behandlung

 

2. Auslösung (10%ige Prüfmusterformu1ierung)

 

2.Kontrollgruppe

 

Prüfmusterseite

Kontrollseite

Prüfmusterseite

Kontrollseite

 

vor Behandl.

vor Behandl.

48h

72h

48h

72h

 

 

nach Behandlung

Hautfaltendicke in mm

 

 

 

 

 

 

M

1.53

1.52

1.66

1.63

1.57

1.56

S

0.17

0.17

0.23

0.22

0.15

0.18

 

Prüfmustergruppe

 

Prüfmusterseite

Kontrollseite

Prüfmusterseite

Kontrollseite

 

vor Behandl.

vor Behandl.

48h

72h

48h

72h

 

 

nach Behandlung

Hautfaltendicke in mm

 

 

 

 

 

 

M

1.71

1.69

1.89

1.96

1.73

1.76

S

0.16

0.14

0.20

0.16

0.18

0.15

M =Mittelwert

S=Standardabweichung

Behandl.=Behandlung

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.
Executive summary:

A study was conducted to assess the sensitizing potential of the test substance in male guinea pigs (DHPW) according to EU Method B.6. and OECD guideline 406 in compliance with GLP.

Intradermal induction was performed using 25% test substance in Cremophor EL (2% v/v in water). Dermal induction and challenge treatment were carried out with 10% test substance in Cremophor EL (2% v/v in water).

The validity of the test system is confirmed by the periodically conducted positive control test using formaldehyde for the maximization test.

Under the test conditions, the test substance showed no evidence for sensitizing properties in guinea pigs.