Registration Dossier
Registration Dossier
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EC number: 432-080-1 | CAS number: -
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 November 1998 to 27 November 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to EU & OECD test guidance in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Details on test material:
- Name: Reaktiv-Orange DYPR 1410
Certificate of analysis: NB203 of December 15, 1993
Content: 73 % (w/w) ±2%
Appearance: orange powder
Solubility: approx. 350 g/l in water
Batch number: DYPR 1410
Date of production: August 17, 1996
Date of receiving: August26, 1998
Date of expiry: August 2003
Storage conditions: darkness at approximately 5°C in a refrigerator
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- Species: New Zealand albino rabbit
Origin: Charles River Deutschland GmbH 88353
Number of animals: 3
Body weight at start of the study: 3.2 - 3.5 kg
Animal maintenance: in fully air-conditioned rooms in separate cages arranged in a battery
Room temperature: 20±3°C
Relative humidity: 50±20%
Lighting time: 12 hours daily
Acclimatization: 1 week under study conditions
Food: ssniff®1 K-H (V2333), ad libitum and hay (approx. 15 g daily)
Water: water from automatic water dispensers, ad libitum
Animal identification: numbered ear tags
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- deionised
- Controls:
- no
- Amount / concentration applied:
- 500 mg per patch
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 72 hours
- Number of animals:
- 3
- Details on study design:
- About 24 hours before the start of the study the hair in the 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 Reaktiv-Orange DYPR 1410 pasted with 0.3 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 (specialty produced by Beiersdorl Aktiengesellschaft). The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.
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.
Examinations of the skin took place after 30 - 60 minutes as well as 24, 48 and 72 hours after removal of the patches.
Erythema, eschar formation and oedema were evaluated numerically according to the score of DRAIZE . All other changes of the skin were recorded.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Remarks:
- mean value
- Time point:
- other: overall 24, 48 and 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Remarks:
- mean value
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Remarks:
- mean value
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Remarks:
- mean value
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Remarks:
- mean value
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Remarks:
- mean value
- Time point:
- other: overall 24, 48, 72 hours
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- 30 - 60 minutes up to 48 hours after decontamination the animals showed very slight erythema up to well-defined erythema and sporadically very slight oedema.
72 hours after decontamination all signs of irritating were reversible. - Other effects:
- During the whole observation period the skin of the animals were discoloured orange.
Any other information on results incl. tables
Generalised Results by Animal –Animals Against Parameters – Multiple Times
Activity – Skin Irritation Results
Study: 98.0701 – Reaktiv-Orange DYPR 1410 – Skin Irritation Test in Rabbits
Group Sex |
Animal Number |
Day Number |
Time Slot |
Bodyweight g |
Treated Flank |
Duration Treatment |
Erythema |
Edema |
1f |
70 |
1 |
Treatment |
3450 |
Left |
4 hours |
|
|
|
30-60 min. After decontamination |
|
|
|
1 |
0 |
||
2 |
24 hours after decontamination |
|
|
|
1 |
0 |
||
3 |
48 hours after decontamination |
|
|
|
0 |
0 |
||
4 |
72 hours after decontamination |
|
|
|
0 |
0 |
||
71 |
1 |
Treatment |
32060 |
Left |
4 hours |
|
|
|
|
30-60 min. After decontamination |
|
|
|
1 |
0 |
||
2 |
24 hours after decontamination |
|
|
|
2 |
1 |
||
3 |
48 hours after decontamination |
|
|
|
1 |
0 |
||
4 |
72 hours after decontamination |
|
|
|
0 |
0 |
||
72 |
1 |
Treatment |
3290 |
Left |
4 hours |
|
|
|
|
30-60 min. After decontamination |
|
|
|
1 |
0 |
||
2 |
24 hours after decontamination |
|
|
|
1 |
0 |
||
3 |
48 hours after decontamination |
|
|
|
0 |
0 |
||
4 |
72 hours after decontamination |
|
|
|
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study Reaktiv-Orange DYPR 1410 is not irritating to skin.
- Executive summary:
Testing for primary dermal irritation provides information on the irritant effect of the test substance on the skin following a single dermal administration and serves as a basis for classification and labelling.
The present study was conducted in compliance with EEC-Guideline B.4."Acute Toxicity Skin Irritation" of the Directive 92/69/EEC and OECD Guidelines for Testing of Chemicals, 404 "Acute Dermal Irritation / Corrosion”. This study was conducted in compliance with the Principles of Good Laboratory Practice (GLP).
Testing of Reaktiv-Orange DYPR 1410 for primary dermal irritation in the rabbit showed, that the substance is not irritating to skin.
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