1,2,3-Oxadiazolium, 5-amino-3-(4-morpholinyl)-, chloride (1:1)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Well documented Guideline-Study, but non-GLP. Only minor deviations or documentation lacks.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

5-amino-3-(morpholin-4-yl)-1,2,3-oxadiazolidin-3-ium chloride

EC Number:

605-254-1

Cas Number:

16142-27-1

Molecular formula:

C6 H11 N4 O2 . Cl

IUPAC Name:

5-amino-3-(morpholin-4-yl)-1,2,3-oxadiazolidin-3-ium chloride

Details on test material:

Batch W003
Purity > 99 %
Molecular formular C6H11ClN4O2

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River GmbH, Germany
- Age at study initiation: no data
- Weight at study initiation: 1947 g +/- 142 g
- Housing: Semibarrier housing. Stainless steel cages with floor grates made ​​of oval steel and feces-collecting pans, 50x55x40 cm, one animal per cage
- Diet (e.g. ad libitum): Altromin 2123, ad libitum
- Water (e.g. ad libitum): Tab water, ad libitum
- Acclimation period: 5 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): Climate, 20°C +/- 2°C, clim
- Humidity (%): 30-40%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12 hours, Light-phase from 6:30 am - 6:30 p.m.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Remarks:

Application of the substance moistened to approximately 6 cm clipped, intact dorsal skin.

Controls:

other: As a control serves a similar, with distilled water. moistened pack (without test substance) on the other shaved area of ​​the skin of the same animal.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 mg / animal
- Concentration (if solution): N/A

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- % coverage: 100
- Type of wrap if used: 2 layers of cheesecloth and aluminum foil, location by occlusiv band

REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data


SCORING SYSTEM: according to EU-Method B.4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 1 h - 72 h

Score:

0

Max. score:

4

Reversibility:

other: Not Applicable, because in all animals no irritation was observed.

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 1 h - 72 h

Score:

0

Max. score:

4

Reversibility:

other: Not Applicable, because in all animals no irritation was observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The single application of the test substance for 4 h on the shaved skin of 3 rabbits did not lead to any skin irritation within 3 days. According to the classification criteria of the EU the substance can be classified as not irritating.