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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:
December 1st 1998 - December 4th 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: According to GLP and OECD methods

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999
Report Date:
1999

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
White powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd. UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.79-3.15 kg
- Fasting period before study: yes
- Housing: suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):16-20 C
- Humidity (%): 43-52%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: December 1, 1998 To:December 4, 1998

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 grams moistened with 0.5 mL distilled water
Duration of treatment / exposure:
4 hours
Observation period:
1, 24, 48 and 72 hours after material removed
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: NA
- Type of wrap if used:cotton guaze patch with surgical tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton ball moistened with distilled water
- Time after start of exposure: 4 hours

SCORING SYSTEM:Draize

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Remarks:
0
Basis:
mean
Time point:
other: After 72 hours
Score:
> 0 - < 0.1
Max. score:
0
Reversibility:
other: no reaction
Remarks on result:
other: There was no irritation after 1 hour or twenty four hours either.
Irritant / corrosive response data:
One site showed very slight erythema one hour after treatement but no other adverse skin reaction noted.
Other effects:
None

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classificatin scheme