C.I. Reactive Blue 224

Skin sensitisation

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 for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method B.6 (Skin Sensitisation)

Deviations:

yes

Remarks:

- measurement of thickness of skin fold rather than observation of skin color

Test guideline 2

Qualifier:

according to guideline

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

Test material information

Constituent 1

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)

Induction

Induction 1

Route:

intradermal

Vehicle:

other: Cremophor EL (2% v/v) in water for injection purposes

Induction 2

Concentration / amount:

- intradermal injection: 0.5%
- dermal application 25%, 25% and 10%

Challenge

Challenge 1

Route:

other: dermal

Vehicle:

other: Cremophor EL (2% v/v) in water for injection purposes

Challenge 2

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 chemical

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.