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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:
1980
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The study was not conducted according to guideline/s and GLP but the report contains sufficient data to permit a meaningful evaluation of study results
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The primary skin irritation study was conducted in six albino rabbits. The skin on the backs was shaved free of hair. The test site was covered with a gauze pad after applying undiluted test material. The skin reactions were scored immediately after cleaning the test sites (24 hours) and at the end of 72 hours (48 hours after first scoring).
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): P-1601 (Oxazolidine E, BIOBANTM CS-1246 Antimicrobial)
- Physical state: Light yellow coloured liquid
- Analytical purity: 94.52%
- Lot/batch No.: M4590
- Stability under test conditions: Not reported assumed to be stable under normal storage conditions

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Not reported
- Age at study initiation: Not reported
- Weight at study initiation: 2.2 ± 0.1 kg
- Housing: Not reported
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported

Test system

Type of coverage:
occlusive
Preparation of test site:
other: left side of the middorsal line was left intact while the skin on the right side was abraded
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mg of test material was applied to each site.
Duration of treatment / exposure:
24 hour(s)
Observation period:
72 hr (48 hr after the first scoring)
Number of animals:
6
Details on study design:
Primary skin irritation evaluations were conducted with 6 rabbits. The skin on the backs was shaved free of hair. The skin on the left side of the middorsal line was left intact, and skin on the right side was abraded by scratching the skin in a tic-tac pattern with a blunt needle. The abrasions were through the stratum corneum, but not deep enough to disturb the derma or induce bleeding.

A 0.5mg sample of the material was applied to each site and covered with a gauze pad. The entire trunk was wrapped with a rubberized cloth and a flexible wire screen held in place with tape.

After the 24-hour exposure, the bindings and patches were removed and the treated sites cleaned. The skin reactions were scored immediately (24 hours) and at the end of 72 hours (48 hours after first scoring).

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Score:
5.7
Remarks on result:
other: Severe irritation
Irritant / corrosive response data:
Refer attachment: Table 4. Primary skin irritation scores in the treated rabbits
Other effects:
None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:
highly irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The compound produced erythema and edema on the intact and abraded sites.  The average irritation score was 5.7, and therefore the material is considered be a severe irritant to skin.
Executive summary:

Primary skin irritation evaluations were conducted with 6 rabbits. The skin on the backs was shaved free of hair. The skin on the left side of the middorsal line was left intact, and skin on the right side was abraded by scratching the skin in a tic-tac pattern with a blunt needle. The abrasions were through the stratum corneum, but not deep enough to disturb the derma or induce bleeding.

A 0.5 mg
sample of the material was applied to each site and covered with a gauze pad. The entire trunk was wrapped with a rubberized cloth and a flexible wire screen held in place with tape.

After the 24-hour exposure, the bindings and patches were removed and the treated sites cleaned.
 The skin reactions were scored immediately (24 hours) and at the end of 72 hours (48 hours after first scoring).

The compound produced erythema and edema on the intact and abraded sites. The average irritation score was 5.7, and therefore the material is considered be a severe irritant to skin.