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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:
28 January to 2 February 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP study carried out in compliance with an internationally recognised guideline

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Batch number: 55089
Purity: 99.9%

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: reputable supplier of laboratory animals
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.72 to 2.90 kg
- Housing: suspended metal cage
- Diet (e.g. ad libitum): free access to commercially available rabbit feed
- Water (e.g. ad libitum): free access to mains drinking water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 20
- Humidity (%): 50 to 65
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hrs light/12 hrs dark

IN-LIFE DATES: From: To: 28 January to 2 February 1998

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5ml
Duration of treatment / exposure:
3 minutes, 1 hour and 4 hours after application
Observation period:
Approximately one hour, 24, 48 and 72 hours
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: not reported
- % coverage: not reported
- Type of wrap if used: cotton gauze pad secured by surgical adhesive tape

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

SCORING SYSTEM: Draize classification scheme.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24,48,72 hrs
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0.7
Max. score:
1
Reversibility:
fully reversible within: 72 hrs
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
0

Any other information on results incl. tables

4 -hour exposure period - very slight erythema was noted at all treated skin sites at the 24 and 48 -hour observations. All treated skin sites appeared normal at the 72-hour observation.

1 -hour exposure period - very slight erythema was noted at the treated skin site at the 24 -hour observation. The treated skin site appeared normal at the 48 -hour observation.

3 - minute exposure period - no evidence of skin irritation was noted during the study.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test material did not meet the criteria for classification as irritant or corrosive according to EU labelling regulations.