1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 May 1995 to 27 July 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C8-18(even numbered) acyl) derivs., hydroxides, inner salts

EC Number:

939-455-3

Molecular formula:

Molecular formula, SMILES notation, InChl and Structural formula cannot be given as the substance is a UVCB.

IUPAC Name:

1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C8-18(even numbered) acyl) derivs., hydroxides, inner salts

Specific details on test material used for the study:

Betadet SHR
Lot number: 7049
pH 7.48
Appearance: viscous yellowish liquid
Storage: Room temperature protected from light

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Source: Accredited supplier
Weight on receipt: 2.0-2.1 kg
Age on receipt: 9-10 weeks
Acclimatisation period: 7 days
Weight on dosing: 2.3-2.4 kg
Housing: Individually in stainless steel cages with grille floor
Temperature: 18-22 degrees C
Humidity: 50-85%
Photoperiod: 12 hour light/dark cycle
Food: Standard rabbit diet UAR 112, ad libitum
Water: Compañia de Aguas de Sabadell, S. A., ad libitum

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 mL of test substance

Duration of treatment / exposure:

Four hours and then removed by washing

Observation period:

30-60 minutes and 24, 48 and 72 hours after the end of the exposure period.

Number of animals:

Three

Details on study design:

The animals were shaved approximately 24 hours before test substance administration using a razor leaving the back and sides from the scapula to the pelvis exposed. One square test zone of 6 cm2 was delimited on the shaved intact skin of one side of the animals. The test substance was applied in a single dose of 0.5 mL. The substance was placed on a 2.5 x 2.5 cm squares of surgical gauze and applied to the corresponding test area. The resulting patches were held close to the body using strips of adhesive tape. The animals were observed for a few moments and returned back to their cages. After 4 hours, the bandage and patches were removed and the remainder of the product eliminated with water.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.22

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Very slight erythema (grade 1) was observed in all animals approximately 60 minutes following removal of the patch; this persisted to 48 hours in one rabbit. No oedema was observed in any rabbit.

Any other information on results incl. tables

Irritation scores

	60 minutes	24 hours	48 hours	72 hours	Mean (24-72 hours)
Erythema	1,1,1	0,0,1	0,0,1	0,0,0	0.22
Oedema	0,0,0	0,0,0	0,0,0	0,0,0	0.00

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Betadet SHR was found to cause minimal transient skin irritation in this study and does not require classification as a skin irritant under CLP.

Executive summary:

A skin irritation study was conducted with Betadet SHR according to OECD Test Guideline 404. The test material was applied to the skin of 3 rabbits (0.5 mL) for 4 hours. The animals were observed for 7 days. The treatment sites were assessed after 1, 24, 48 and 72 hours. Very slight erythema (grade 1) was observed in all animals approximately 60 minutes following removal of the patch; this persisted to 48 hours in one rabbit.  No oedema was observed in any rabbit. Betadet SHR was found to cause minimal transient skin irritation in this study and does not require classification as a skin irritant under CLP.