Registration Dossier

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: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): KBM-04

- Physical state: colourless liquid

- Storage condition of test material: Approximately 4°C in the dark

- Other: pH at 10% w/w aqueous preparation of the test material - 6.7

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd., Cheshire, UK
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2-3.5 kg
- Housing: individually housed in suspended metal cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: minimum of five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): minimum 15
- 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:
4 hours
Observation period:
14 days
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal/flank area
- Type of wrap if used: elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the test site was gently swabbed with cotton wool soaked in 75% IMS
- Time after start of exposure: 4 h

SCORING SYSTEM: Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24/48/72h
Score:
4
Max. score:
4
Reversibility:
fully reversible within: 14 days
Irritant / corrosive response data:
Well defined erythema was noted at all treated skin sites at the 24, 48 and 72 hour observations.The oedema extended ventrally below one treated skin site at the 24 and 48 hour observations. Scattered areas of blanching of the skin and dermal haemorrhage were noted at two treated skin sites at the 24, 48 and 72 hour observations. Loss of skin elasticity was noted at one treated skin site at the 72 hour observation. Crust formation, precluding evaluation of erythema and oedema, was noted at all treated skin sites at the 7-day observation. Slight desquamation was noted at all treated skin sites at the 14 day observation. The primary dermal irritation index was calculated to be 4.8.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material is found irritating to skin, based on a mean of 2 for erythema and 4 for oedema in three in a reliable study conducted according to OECD 404 and in compliance with GLP.