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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline Study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2008
Report Date:
2008

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted 24 April 2002)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
Safepharm Laboratories Limited, Shardlow, Derbyshire, UK

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Oxooil HS9
- Physical state: pale yellow liquid
- Analytical purity: not stated
- Storage condition of test material: Room temperature in the dark

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, UK
- Age at study initiation: twelve to twenty weeks
- Weight at study initiation: 2 - 3.5 kg
- Housing: individually
- Diet: Free access to food (Certified Rabbit Diet)
- Water: Free access to drinking water
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 - 23
- Humidity (%): 30 - 70
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
3 min, 1 h and 4 h
Observation period:
one hour following the removal of the patches, 24, 48 and 72 hours later; additional observations were made on Days 7 and 14;
Number of animals:
- 3 min and 1 h: 1 rabbit;
- 4 h: 3 rabbits
Details on study design:
TEST SITE
- Area of exposure: dorsal/flank area (one animal), back (two animals)
- Type of wrap if used: The test material was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in distilled water
- Time after start of exposure: 3 minutes, 1 hour and 4 hours after application

SCORING SYSTEM: according to OECD 404 / Draize J. H. (1959) "Dermal Toxicity" In: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics. Association of Food and Drug Officials of the United States, Austin, Texas, p.46-59

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
(animal 1 - 3)
Time point:
other: 24 - 48 - 72 h
Score:
1.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: see table below for details
Irritation parameter:
edema score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: edema (score 1) only detected in one animal; see table below for details
Irritant / corrosive response data:
- 3-Minute Exposure Period:
Very slight erythema was noted at the treated skin site at the 24-hour observation, with well defined erythema and very slight oedema at the 48-hour observation. Very slight erythema, very slight oedema and loss of skin elasticity were noted at the 72-hour observation

- 1-Hour Exposure Period:
Very slight erythema was noted at the treated skin site one hour after patch removal and at the 24-hour observation, with well defined erythema and very slight oedema at the 48-hour observation. Very slight erythema, very slight oedema and loss of skin elasticity were noted at the 72-hour observation. Slight desquamation was noted at the 7-day observation.

- 4-Hour Exposure Period:
Very slight erythema was noted at one treated skin site one hour after dressing removal. Very slight to well defined erythema was noted at all treated test sites at the 24-hour, 48-hour and 72-hour observations. Very slight oedema was noted at one treated skin site one hour after dressing removal and at the 24-hour, 48-hour and 72-hour observations. Loss of skin elasticity was noted at two treated skin sites at the 48-hour observation and at all
treated skin sites at the 72-hour observation, with loss of flexibility at one treated skin site. Crust formation was noted at one treated skin site, with slight desquamation at one other treated skin site at the 7-day observation. One treated skin site appeared normal at the 7-day observation, and one treated skin site appeared normal at the 14-day observation.

Any other information on results incl. tables

Exposition:  3 min
Animal  Reading  Erythema Edema Symptoms
1 1 h 0 0  
1 24 h 1 0  
1 48 h 2 1  
1 72 h 1 1 loss of skin elasticity
1 7 d 0 0  
1 14 d 0 0  
mean 24 - 72 h 1.30 0.70  
Exposition:  1 h
Animal  Reading  Erythema Edema Symptoms
1 1 h 1 0  
1 24 h 1 0  
1 48 h 2 1  
1 72 h 1 1 loss of skin elasticity
1 7 d 0 0 slight desquamation
1 14 d 0 0  
mean 24 - 72 h 1.30 0.70  

Exposition:  4 h 
Animal  Reading  Erythema Edema
1 1 h 1 1
2 1 h 0 0
3 1 h 0 0
1 24 h 2 1
2 24 h 1 0
3 24 h 1 0
1 48 h 2 1
2 48 h 1 0
3 48 h 1 0
1 72 h 2 1
2 72 h 1 0
3 72 h 1 0
1 7 d 0 0
2 7 d 0 0
3 7 d 0 0
1 14 d 0 0
2 14 d not required not required
3 14 d not required not required
mean animal 1 24 - 72 h 2 1
mean animal 2 24 - 72 h 1 0
mean animal 3 24 - 72 h 1 0
mean animal 1-3 24 - 72 h 1.30 0.30

Primary irritation index = 1.7

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU