[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2021

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

2-fluoro-4-methyl-1,3,2-dioxaphospholane

Cas Number:

16415-09-1

Molecular formula:

C3H6FO2P

IUPAC Name:

2-fluoro-4-methyl-1,3,2-dioxaphospholane

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

not specified

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

According to the Draize method, the test substance was applied 0.5 mL to the skin.

Duration of treatment / exposure:

Frequency and period of administration
Once a day

Frequency and period of application
Initial test: Apply twice and hold for 3 minutes and 1 hour each time.

Observation period:

Corrosiveness was observed immediately after 1 hour of observation after applying the first patch for 3 minutes and immediately after removal applying the second patch. At that point the experiment was terminated.

Number of animals:

1

Details on study design:

The one day before the test substance was applied, the hair on the back was removed using electric hair removal for animals to avoid scratching. Place the gauze (Daehan Medical. Co., Ltd.) to the transparent film (Tegaderm, 3M), and the test substance was evenly applied to gauze (width x length, 2 cm x 3 cm). Then after a non-irritating tape (Coban, 3M) was wound, and both sides were fixed with medical use tape (Micropore, 3M).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 1h

Reversibility:

not specified

Remarks on result:

other: Test was ended after 1 hour.

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 1 h

Score:

1

Reversibility:

not specified

Remarks on result:

other: Test was ended after 1 hour.

Applicant's summary and conclusion

Interpretation of results:

Category 1A (corrosive) based on GHS criteria

Conclusions:

This study was performed to evaluate the acute dermal irritation / corrosion of the test substance OA-1300 in New Zealand White rabbits.
MSDS (Material Safety Data Sheet) toxicity information – Toxicological information of skin corrosion has been ‘No data’. In order to determine the corrosiveness, three patches of test substances were sequentially applied and observed during the initial test. Corrosiveness was observed immediately after 1 hour of observation after applying the first patch for 3 minutes and immediately after removal after applying the second patch for 1 hour. At that point the experiment was terminated.
Results were as follows;
There was no abnormality observed of clinical signs and no dead animal for observation period.
In the initial test, immediately after removing the first patch for 3 minutes, no skin reaction was observed at the site of application of the test substance. However, degree 1 edema and corrosion were observed at 1 hour after removal. Also, immediately after removal of the second patch for 1 hour, corrosion was observed at the site of application of the test substance.
Based on the results of the acute dermal irritation / corrosion of the test substance OA-1300 in New Zealand White rabbits, it was verified as ‘Category 1 (corrosive) / Sub-category 1A’ substance according to GHS (Globally Harmonized System of Classification and Labelling of Chemicals) classification.