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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2001
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was conducted in compliance with OECD GLP (1997) regulations.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
MV31 K-Salz
IUPAC Name:
MV31 K-Salz
Test material form:
solid: crystalline
Details on test material:
- Name of test material (as cited in study report): MV31 K-Salz
- Substance type: Mono-constituent
- Physical state: Solid (Grey granules)
- Analytical purity: 88%
- Purity test date: 19 September 2000
- Lot/batch No.: Lot no. 1268147/1-1268154/1
- Expiration date of the lot/batch:31 December 2001
- Stability under test conditions: Guranteed for 4 hours
- Storage condition of test material: Darkness at approximately 20 C in a fume cupboard

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 Kissleg
- Age at study initiation: No data
- Weight at study initiation: 2.1-3.7 kg
- Housing: Individually in a fully air-conditioned room
- Diet (e.g. ad libitum): Ssniff K-H (V2333), ad libitum and hay (approx. 15g daily)
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 C
- Humidity (%): 30-70%
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 23 January 2001 To: 09 February 2001

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
water
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution): 0.5 g of the test article was pasted with 0.15 mL deionized water prior to application

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.15 mL of deionized water was used to create a paste of the test article
Duration of treatment / exposure:
3 minutes, 1 hour, and 4 hours
Observation period:
Observations for skin irritation were recorded at 30-60 minutes and 24, 48 and 72 hours after unwrapping.
Number of animals:
5
Details on study design:
TEST SITE
- Area of exposure: 3 minutes: left hind flank, 1 hour: left front flank, 4 hours: right flank
- Type of wrap if used: Semi-occlusive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Warm tap water
- Time after start of exposure: Immediately following 3 minute, 1 or 4 hour exposure

SCORING SYSTEM: Draize

Results and discussion

In vivo

Results
Irritation parameter:
erythema score
Basis:
other: Eyrthema scores of 4 were observed in both animals treated for 4 hours.
Time point:
other: 30-60 minutes and at 24 hours
Score:
ca. 4
Max. score:
4
Reversibility:
other:
Remarks on result:
other: Animals were euthanized at 24 hours post-dose due to the severity of the skin reactions.
Irritant / corrosive response data:
No skin reactions were observed in the initial treated animal following 3 minute, 1 hour, and 4 hour exposures. Severe erythema (scores: 4) was observed at 30-60 minutes and 24 hours post-dose in both animals treated for 4 hours. Edema (score: 2) was also boserved in one of those animals at 24 hours post-dose. In addition, necrosis, moderate induration, and pitted skin surface were observed at 24 hours post-dose. In the two additional animals treated for 3 minutes, erythema was observed at 30-60 minutes (scores: 2) and 24 hours (scores: 1) post-dose and cleared by 48 hours post-dose. No edema was observed at any time in these animals treated for 3 minutes.

Applicant's summary and conclusion

Interpretation of results:
corrosive
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Based on the results of the study, the test article is corrosive to the skin.
Executive summary:

The primary dermal irritation/corrosion potential of the test article (grey granules, purity approx. 88 Fl.%, CASRN 496805-64-2, Lot no. 1268147/1-1268154/1) was evaluated in female New Zealand White rabbits. This study was performed in compliance with OECD GLP (1997) and the German Chemical Act (1999). The study method was based on OECD 404 (1992) and Commission Directive 92/69/EEC (1992). The hair was clipped from the dorsal skin of five female rabbits. The test material (0.5 g pasted with 15 mL deionized water) was placed under gauze on three intact test sites of one animal. The torso was wrapped with plastic in a semi-occlusive manner and secured with non-irritating tape for 3-minute, 1-hour, and 4-hour exposures. Since no skin reactions were observed, two additional animals were similarly treated for a 4-hour exposure. Since corrosive skin reactions were observed in these two animals, two additional animals were similarly treated for a 3-minute exposure. Observations for skin irritation (erythema and edema) were recorded at 30-60 minutes and at 24, 48, and 72 hours after unwrapping. The Primary Irritation Index (PII) could not be calculated since the animals treated for 4 hours were euthanized at 24 hours after unwrapping. No skin reactions were observed in the initial treated animal following 3-minute, 1-hour, and 4-hour exposures. Severe erythema (scores: 4) was observed at 30-60 minutes and 24 hours post-dose in both animals treated for 4 hours. Edema (score: 2) was also observed in one of these animals at 24 hours post-dose. Large areas of skin discoloration were observed at 30-60 minutes and 24 hours post-dose. In addition, necrosis, moderate induration, and pitted skin surface were observed at 24 hours post-dose. These animals were euthanized at 24 hours post-dose due to the severity of the skin reactions. In the two additional animals treated for 3 minutes, erythema was observed at 30-60 minutes (scores: 2) and 24 hours (scores: 1) post-dose and cleared by 48 hours post-dose. No edema was observed at any time in these animals treated for 3 minutes. Based on the results of this study, the test article is corrosive to the skin.