REAKTIV-ORANGE DYPR 934

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1999-02-02 02 to 1999-02- 09

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted in compliance with EEC-Guideline B4 and OECD Guidelines for testing chemicals 404 according to the good laboratory practice regulations annex of paragraph 19a, section 1 of the chemical law of July, 25, 1994.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Details on test material:

-Name of test material (as cited in study report): Reaktiv-Orange DYPR934

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
rabbit
New Zealand White
- Origin: Charles River Deutschland GmbH
88353 Kißlegg
- Age at study initiation: 3 healthy young adult rabbits were used
- Weight at study initiation: 2.0-2.4 kg
- Housing: In fully air-conditioned rooms in separate cages arranged in a battery.
- Food: ssniff® K-H (V2333) ad libitum and hay (approx. 15 g daily)
- Water (e.g. ad libitum): Water from automatic water dispensers, ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 °C (± 3 °C)
- Relative humidity: 50 ± 20 %
- Air changes (per hr): at least 10 X
- Photoperiod (hrs dark / hrs light): 12 hours daily
-Animals Identification: numbered ear tags

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: Deionized water

Controls:

no

Amount / concentration applied:

500 mg

Duration of treatment / exposure:

4 h

Observation period:

Examinations of the skin took place after 30 - 50 minutes as well as 24, 48 and 72 hours after removal of the patches.
Because of persistent irritations 72 hours after removal of the patches, additional readings were performed after7 days.

Number of animals:

3

Details on study design:

TEST PROCEDURE AND TEST SITE

About 24 hours before start of study the hair dorsal region of the body of 3 rabbits was removed with an electric clipper over an area of about 25 cm2. Only animals with intact skin were used.
Each animal was treated with 0.5 g (500 mg) Reaktiv-Orange DYPR 934 pasted with 0.5 ml deionized water.
The substance was administered over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster (specially produced by Beiersdorf Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

EXPOSURE PERIOD AND REMOVAL OF TEST SUBSTANCE

The exposure period was 4 hours. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water.
SCORING SYSTEM:
Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(Erythema and eschar formation)

Basis:

animal: 61

Time point:

other: overall at 24, 48 and 72 h

Score:

1.66

Results 2

Irritation parameter:

erythema score

Remarks:

(Erythema and eschar formation)

Basis:

animal: 62

Time point:

other: overall at 24, 48 and 72 h

Score:

0.66

Results 3

Irritation parameter:

erythema score

Remarks:

(Erythema and eschar formation)

Basis:

animal: 63

Time point:

other: overall at 24, 48 and 72 h

Score:

1.33

Results 4

Irritation parameter:

erythema score

Remarks:

Erythema and eschar formation

Basis:

mean

Remarks:

All animals

Time point:

other: overall at 24, 48 and 72 h

Score:

1.22

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

erythema score

Remarks on result:

other: Max. duration: 48 d; Max. value at end of observation period: 0 (related to all animals)

Results 6

Irritation parameter:

edema score

Basis:

animal: 61

Time point:

other: overall at 24, 48 and 72 h

Score:

0.66

Results 7

Irritation parameter:

edema score

Basis:

animal: 62

Time point:

other: overall at 24, 48 and 72 h

Score:

0

Results 8

Irritation parameter:

edema score

Basis:

animal: 63

Time point:

other: overall at 24, 48 and 72 h

Score:

1

Results 9

Irritation parameter:

edema score

Basis:

mean

Remarks:

All animals

Time point:

other: overall at 24, 48 and 72 h

Score:

0.55

Max. score:

4

Reversibility:

fully reversible

Results 10

Irritation parameter:

edema score

Remarks on result:

other: Max. duration: 0 d; Max. value at end of observation period: 0 (related to all animals)

Irritant / corrosive response data:

Reversibility of any observed effect: Changes fully reversible within 7 days

Other effects:

30 - 60 minutes up to 3 days after removal of the plaster the animals showed very slight up to well-defined erythema and oedema. Additionally, the skin surface was dry-rough and orange discolored. 7 days after administration all signs of irritation were reversible.
Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE.
All other changes of the skin were recorded.

Any other information on results incl. tables

Table II:                       Generalised Results By Animal- Animals against parameters-Multiple Times                                            Activity –skin irritation Results          Study : 990015 – Reaktiv-Orange DYPR 934-Skin Irritation Test in Rabbits
Group Sex	Animal Number	Day Number	Time slot	Body weight (g)	Treated Flank	Duration Treatm.	Erythema	Edema
1f	61	1	Treatment 30-60 min. after decontamination	2350	Left	4 hours	3	2
		2	24 hours. after decontamination				2	1
		3	48 hours after decontamination				2	1
		4	72 hours after decontamination				1	0
		8	7 days after decontamination				0	0
	62	1	Treatment 30-60 min. after decontamination	2050	Left	4 hours	2	1
		2	24 hours. after decontamination				2	0
		3	48 hours after decontamination				0	0
		4	72 hours after decontamination				0	0
		8	7 days after decontamination				0	0
	63	1	Treatment 30-60 min. after decontamination	2240	Left	4 hours	2	2
		2	24 hours. after decontamination				1	2
		3	48 hours after decontamination				2	1
		4	72 hours after decontamination				1	0
		8	7 days after decontamination				0	0

 

Table III: Clinical observations-clinical signs by Animal          Study : 990015 – Reaktiv-Orange DYPR 934-Skin Irritation Test in Rabbits
Day numbers relative to Start Date
Group Sex 1f	Animal number	Clinical sign	1 30-60 min After decontamination	2 24 hours after decontamination	3 48 hours after decontamination	4 72 hours after decontamination	8 7 days after decontamination
	61	No Abnormalities Detected	-	-	-	-	X
		Skin discolored-small area	o	o	o	o	-
		Skin surface dry and rough	-	X	X	X	-
	62	No Abnormalities Detected	-	-	X	X	X
		Skin discolored-small area	o	-	-	-	-
		Skin surface dry and rough	-	X	-	-	-
	63	No Abnormalities Detected	-	-	-	-	X
		Skin discolored-small area	o	o	o	o	-
		Skin surface dry and rough	-	X	X	X	-
-= result to left has an associated comment or marker X= present o=orange Nominal Dose: Group I = 0.5 g (moistened)

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Conclusion:
Based on the results of this study Reaktiv-Orange DYPR 934 is slightly irritating to skin

Executive summary:

In a 4 hours skin irritation / corrosion study, 500 mg of Reaktiv-Orange DYPR 934 was applied in the intake skin of 3 healthy young adult New Zealand white Rabbits under semi occlusive conditions.

The aim of this study was to obtain information on the irritant effect of Reaktiv-Orange DYPR 934 on the skin after a single dermal administration (as a basic of the classification and labeling).

 30-60 minutes up to 3 days after removal of the plaster the animals showed very slight up to well-defined erythema and oedema.

The skin surface was dryrough and orange discolored.

Testing of Reaktiv-Orange DYPR 934 for primary dermal irritation showed that the substance would be classified as slightly irritating to the skin.

Results Synopsis

Test Substance	Test animals	ENVIRONMENTAL CONDITIONS	Control	Results	Conclusion (based on the test conditions)
Reaktiv-Orange DYPR 934	New Zealand albino rabbit	- Temperature (°C): 20°C (± 3°C) - Relative humidity: 50 ± 20% - Air changes (per hr): at least 10 X - Photoperiod (hrs dark / hrs light): 12 hours daily	Patch (the substance was administered over the whole surface of 2.5 X2.5 cm cellulose patch on a piece of surgical plaster)	30-60 minutes up to 3 days after removal of the plaster the animals showed very slight up to well-defined erythema and oedema. -Skin surface was dryrough and orange discolored.	Reaktiv-Orange DYPR 934 is slightly irritating to skin.