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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Jul. 02, 2002 to Aug. 29, 2002
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted according to EU Method B.4. OECD Guideline 404 and OPPTS 870.2500 in compliance with GLP
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2002
Report date:
2002

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
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Reaktiv-Scharlach F01-0467


Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, 88353 Kiβlegg
- Weight at study initiation: 2.98-3.70 kg
- Diet: ssniff K-H (V2333), ad libitum and hay (approx. 15 g daily)
- Water: water from automatic water dispensers, ad libitum
- Acclimation period: 1 wk

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light

IN-LIFE DATES: From: Jul. 02, 2002 To: Jul. 05, 2002

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
other: sesame oil
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 g of test substance pasted with 0.28 mL sesame oil


Duration of treatment / exposure:
4 h
Observation period:
24, 48 and 72 h after removal of the patches

Number of animals:
Three
Details on study design:
TEST SITE
- Area of exposure: Dorsal region of the body
- % coverage: 25 cm2
- Type of wrap if used: Yes, The test substance was evenly distributed over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Yes, with warm water
- Time after start of exposure: 4 h

SCORING SYSTEM: Erythema, eschar formation and edema were evaluated numerically according to the score of DRAIZE

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 4 h
Score:
0
Max. score:
4
Reversibility:
other: no erythema observed
Remarks on result:
other: -
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 4 h
Score:
0
Max. score:
4
Reversibility:
other: no edema observed
Remarks on result:
other: -
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no erythema observed
Remarks on result:
other: -
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no edema observed
Remarks on result:
other: -
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 72 h
Score:
0
Max. score:
8
Reversibility:
other: no irritation observed
Remarks on result:
other: -
Irritant / corrosive response data:
No abnormalities detected in any of the tested animals at time points till 72 h


Other effects:
No signs of irritations were observed during the whole observation period.
No clinical signs of systemic toxicity were observed.

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the test conditions, the test substance was considered to be non-irritating to rabbit skin
Executive summary:

A study was conducted to assess the skin irritation potential of test substance to the rabbit skin according to EU Method B.4., OECD Guideline 404 and OPPTS 870.2500 in compliance with GLP.

 

Three animals were treated with 0.5 g of the test substance moistened in 0.28 mL sesame oil using semi-occlusive patches for 4 h. After the exposure period all remnants of the test substance were carefully removed from the skin with warm tap water. The skin was evaluated for erythema, eschar formation and edema numerically according to the score of Draize system for up to 72 h after patch removal.

No signs of irritation were observed during the whole observation period. No clinical signs of systemic toxicity were observed.

Under the test conditions, the test substance was considered to be non-irritating to rabbit skin.