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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 01 - 04, 1996
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study is performed in accordance with OECD guideline 404 (1992) and meets the requirements of GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1996
Report date:
1996

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: Directive 92/69/EEC, B.4 OECD 404
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Nikkol VC-IP
- Substance type: Colourless to light yellow transparent liquid
- Physical state: Liquid
- Stability under test conditions: stable
- Storage condition of test material: In refrigerator in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Broekman Institute, Someren, The Netherlands.
- Age at study initiation: Approx. 8 weeks
- Housing: singly housed
- Diet: LKK-20, pellet diameter 4mm, Hope Farms, Woerden, The Netherlands
- Water: Tap water, certificates of quarterly analysis were examined and retained in the NOTOX archives.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 ml of the test substance was applied to the skin of one flank
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 10x15 cm2
- Type of wrap if used: a surgical gauze patch of 2x3 cm. The patch was mounted on Micropore tape
REMOVAL OF TEST SUBSTANCE
- the dressing was removed and the remaining test substance removed using a tissue moistened with tap-water and subsequently a dry tissue
- Time after start of exposure: 4 hours

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
(mean score 1)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
(mean score 2)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
(mean score 3)
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Max. score:
4
Irritant / corrosive response data:
Reversibility of any observed effect: Changes fully reversible within 2 days
Other effects:
None.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dermal application of NIKKOL VC-IP resulted in a primary irritation index of 0.3 (negligibly irritating) when applied to the intact rabbit skin.