Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: R7623 Technical, solid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
yes, concurrent no treatment
Duration of treatment / exposure:
4 hours
Observation period:
55 minutes; 24, 48 and 72 hours after dressing removal
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: range
Time point:
other: 55 minutes to 72 hours
Score:
0 - 1
Max. score:
1
Reversibility:
fully reversible
Remarks on result:
other: 2 of 3 rabbits had very slight erythema at 55 minutes
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 55 minutes to 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no irritation observed

Applicant's summary and conclusion

Interpretation of results:
other: minimally irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test substance need not be labeled as a skin irritant
Executive summary:

The flank skin of 3 albino rabbits was exposed to 0.5 g of the test substance moistened with 0.5 mL Milli-RO water for 4 hours using semi-occlusive dressings. The test substance caused no adverse effects to the skin, except very slight erythema in 2 animals 55 minutes after bandage removal.

The primary skin irritation index amounts to 0. Based on these results, the test substance should be considered minimally irritating to the skin.

According to the criteria laid down in Annex VI of the EED Council Directive 67/548/EEC (amended by Directive 83/467/EEC), the test substance need not be classified as a skin irritant.