Registration Dossier

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: Performed to OECD methods in 1987 and although not performed to recognised GLP, followed principles of Good Laboratory Practice
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report Date:
1987

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: crystalline
Details on test material:
Yellow cyrstalline powder

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The animals were kept in quarantine for 14 days before the study and fully examined for health 1 day before testing
Room temperature 20 C (+/- 2C)
Relative humidity ca 50%
Light / dark conditions, 12 hourly
Ventilation, 10 changes per hour

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
not required
Amount / concentration applied:
500 mg dispersed in water
Duration of treatment / exposure:
4 hours
Observation period:
Up to 14 days
Number of animals:
3 Rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
0
Reversibility:
other: No adverse effects
Remarks:
No adverse effects
Remarks on result:
other: No adverse effects
Remarks:
No adverse effects
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Reversibility:
other: No adverse effects
Remarks:
No adverse effects
Remarks on result:
other: No adverse effects
Remarks:
No adverse effects
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Reversibility:
other: No adverse effects
Remarks:
No adverse effects
Remarks on result:
other: No adverse effects
Remarks:
No adverse effects
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Reversibility:
other: No adverse effects
Remarks:
No adverse effects
Remarks on result:
other: No adverse effects
Remarks:
No adverse effects
Other effects:
No adverse effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
No adverse effects following 4 hour exposure of wetted material with semi-occlusive dressing
Executive summary:

Valid study, showing no adverse effects