Guanidine, N-phenyl-, compd. with carbonic acid, hydrate (2:1:2)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

This study has been performed in compliance with Good Laboratory Practice (GLP) in Switzerland, Procedures and Principles, March 1986, issued by the Federal Department of the Interior and the Intercantonal Office for the Control of Medicaments, Switzerlan

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

485-350-6

EC Name:

-

Cas Number:

405095-33-2

Molecular formula:

C15H20N6O3

IUPAC Name:

Carbonic acid - 1-phenylguanidine (1:2)

Test material form:

solid: bulk

Test animals

Species:

rabbit

Strain:

New Zealand White

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

other: gauze patches moistened with 0.5% (w/v) carboxymethylcellulose in 0.1% (w/v) aqueous polysorbate 80

Controls:

other: contralateral flank was used as control

Duration of treatment / exposure:

4 hours

Observation period:

The skin reactions were evaluated 1, 24, 48, and 72 hours after removing the gauze patches according to the OECD scoring system.

Number of animals:

3

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Because no reactions were observed at 24 hours to 72 hours after removing the bandages, the substance can be classified according to the EEC classification as non-irritant in albino rabbits.

Executive summary:

The test was conducted according to OECD guideline 404 in compliance with GLP.

The irritatitive/corrosive effects of the substance were investigated in 3 female rabbits.

Under the experimental conditions employed CA 1139 A induced slight erythema reactions when applied to the clipped albino rabbit skin. The reactions were observed only one hour after removing the bandages. Because the mean values of the recordings 24 to 72 hours after application are scored zero, CA 1139 A can be classified as non-irritating according to the Commission Directive 83/467/EEC.