Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium

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 31 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium

EC Number:

236-164-7

EC Name:

Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium

Cas Number:

13197-76-7

Molecular formula:

C17H37NO4S

IUPAC Name:

dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium

Test material form:

solid

Specific details on test material used for the study:

Betadet S-20
Lot number: 7244
Appearance: transparent viscous liquid
pH: 7.49
Stored: Room temperature, protected from light.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Three New Zealand White male rabbits were used.
Weight on receipt: 2.1-2.2 kg
Age on receipt: approximately 9-11 weeks
Source: Accredited supplier
Housing: Individually in stainless steel cages with a grill floor
Acclimatisation period: at least seven days
Weight at administration of test substance: 2.3-2.8 kg
Temperature: 17-22 degrees C
Humidity: 50-90%
Photoperiod: 12 dark/light cycle
Diet: Standard rabbit diet UAR 112, supplied by PANLAB, S. L., ad libitum
Water: Supplied by Compañia de Aguas de Sabadell, ad libitum

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

Four hours

Observation period:

The reaction of the test zone was evaluated approximately 30-60 minutes and 24, 48 and 72 hours after the end of the exposure period. Additional observations were carried out after seven days to check the reversibility of the observed reactions.

Number of animals:

Three

Details on study design:

Animals were shaved approximately 24 hours before administration using an electric razor, leaving the back and sides exposed from the scapula to the pelvis.

One square test zone, measuring approximately 6 square centimetres 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 2.5 x 2.5 cm squares of hydrophilic gauze and applied to the corresponding test area. The resulting patches were held in place with strips of adhesive tape. A strip of gauze was wrapped around the trunk of the animals using adhesive tape to hold the patches in place.

The animals were observed following administration before being returned to their cages.

After a 4-hour period, the 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:

0.78

Max. score:

4

Reversibility:

fully reversible within: 7 days

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Any other information on results incl. tables

Scores for irritation

	60 minutes	24 hours	48 hours	72 hours	Mean (24-72 hours)	7 days
Erythema	1,1,1	1,1,1	0,1,1	0,1,1	0.78	0,0,0
Oedema	0,0,0	0,0,0	0,0,0	0,0,0	0.00	0,0,0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Minimal transient irritation was observed in this study; the substance does not require classification according to CLP criteria.

Executive summary:

A skin irritation study was conducted with Betadet S-20 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. The sites were assessed after 7 days to determine reversibility. One hour after patch removal, slight edema (Grade 1) was noted for all 3 animals. The mean effect scores over time of 24, 48 and 72 hours were 0.78 for erythema and 0.0 for oedema. The effects were fully reversible within 7 days. Minimal transient irritation was observed in this study; the substance does not require classification according to CLP criteria.