Betaines, coco alkyldimethyl(3-sulfopropyl)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-11-24 - 1982-12-13 (experimental phase)

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted May 12, 1981

Deviations:

no

GLP compliance:

yes

Remarks:

FDA principles

Test material

Test material information

Constituent 1

Reference substance name:

Betaines, coco alkyldimethyl(3-sulfopropyl)

EC Number:

269-225-1

EC Name:

Betaines, coco alkyldimethyl(3-sulfopropyl)

Cas Number:

68201-55-8

Molecular formula:

C7H17NO3S·[CH2]6-16

IUPAC Name:

[3-(dodecyldimethylazaniumyl)propyl]trioxo-λ⁶-sulfanuide

Test material form:

liquid

Remarks:

clear

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, 4414 Fuellinsdorf, Switzerland
- Age at study initiation: approx. 12 weeks
- Weight at study initiation: 2.3 - 3.0 kg
- Housing: Caged individually in stainless steel cages with automatic drinking water supply and cleaning system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, 7830 Emmendingen, Germany)
- Diet (e.g. ad libitum): Pelleted standard Kliba 23/341/1 rabbit maintenance diet (Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) defined for acceptable contaminant level, ad libitum
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2°C
- Humidity (%): 55±10%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1982-11-24 To: 1982-12-13

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5g
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4h

Observation period:

14 days

Number of animals:

3 (2 males, 1 female)

Details on study design:

TEST SITE
- Area of exposure: back and flanks
- % coverage: 10*10 cm² clipped, 3*3 cm² exposed
- Type of wrap if used: The test material was applied under a patch of surgical gauze approx. 3*3 cm. When the patch was in place it was covered with impermeable material and fastened to the body with adhesive tape.

OBSERVATION TIME POINTS
1h, 24h, 48h, 72h, 7 d, 14d

SCORING SYSTEM:
- Method of calculation: Primary skin irritation index: The scores read after 1, 24, 48, and 72 h for erythema and edema for intact skin were summed up and divided by 4 (FHSLA paragraph 191.11).
Scoring was performed according to Draize JH 1959
The test material was classified according to:
- ETAD (Ecological and toxicological association of the dye stuffs manufacturing industries) Methods 001-003 (1979)
- VCI (Verband der chemischen Industrie, BRD), Sicherheitsdatenblatt

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

24/48/72 h

Score:

2.5

Max. score:

3

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

identical for all three rabiits

Time point:

24/48/72 h

Score:

2

Max. score:

3

Reversibility:

fully reversible within: 14 days

Results 3

Irritation parameter:

edema score

Basis:

mean

Remarks:

identical for all three rabiits

Time point:

24/48/72 h

Score:

0

Max. score:

0

Reversibility:

fully reversible within: 14 days

Irritant / corrosive response data:

The test item showed a slight irritation when applied to the intact rabbit skin.
Destructions or irreversible alterations of the treated skin were observed in 2 out of three rabbits. Thus it was concluded that a corrosion effect has occurred on the skin.
After 7 observation days, the skin at the application site was of harder consistency and elevated to the surrounding skin area.
In the area of application no discolouration of the skin was observed (score: zero) which could be related to effects of the test material at any observation time.

Other effects:

- Other adverse systemic effects: No acute toxicological signs were observed in the animals during the test period, no mortalities occurred.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (corrosive) based on GHS criteria

Conclusions:

The study was conducted under GLP according to OECD TG 404 on the registered substance itself. The method is to be considered scientifically reasonable with no deficiencies. Hence, the results can be considered as sufficiently reliable to assess the irritating properties of the test item.
According to Regulation 1272/2008 and amendments, Skin Corrosion means the production of irreversible damage to the skin; namely, visible necrosis through the epidermis and into the dermis, following the application of a test substance for up to 4 hours. Corrosive reactions are typified by ulcers, bleeding, bloody scabs, and, by the end of observation at 14 days, by discolouration due to blanching of the skin, complete areas of alopecia, and scars. Histopathology shall be considered to evaluate questionable lesions. Skin Irritation means the production of reversible damage to the skin following the application of a test substance for up to 4 hours.
The test item gave an overall irritation index of 2.5. Employing the criteria for skin irritation classification according to Regulation 1272/2008 and amendments, a substance must be classified as Skin Irr. Cat. 2, if Mean value of ≥ 2,3 - ≤ 4,0 for erythema/ eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions. In this study, mean erythema and edema scores would be 2 and 1, respectively, at 24, 48 and 72 hours after patch removal, the test item showed a slight irritation when applied to the intact rabbit skin.
However, destructions or irreversible alterations of the treated skin were observed in 2 out of three rabbits. Thus it was concluded that a corrosion effect has occurred on the skin. After 7 observation days, the skin at the application site was of harder consistency and elevated to the surrounding skin area.
In the area of application no discolouration of the skin was observed (score: zero) which could be related to effects of the test material at any observation time. Also, no ulcers, bleeding, or bloody scabs, as indicated by the regulation, were noted in the report. However, the criterion for irreversible damage to the skin in general is met, so the test item should be precautionarily classified as Skin Corr. Cat. 1.

Executive summary:

The skin irritating / corrosive properties of the test item were evaluated in a OECD 404 GLP study in three New Zealand White rabbits after 4h occlusive application. The test item showed a slight irritation when applied to the intact rabbit skin, resulting in a primary skin irritation score of 2.5 or mean erythema and edema scores of 2 and 1, respectively, at 24, 48 and 72 hours after patch removal. Destructions or irreversible alterations of the treated skin were observed in 2 out of three rabbits. Thus it was concluded that a corrosion effect has occurred on the skin. After 7 observation days, the skin at the application site was of harder consistency and elevated to the surrounding skin area. The test item is precautionarily classified as Skin Corr. Cat. 1 according to Regulation 1272/2008 and amendments.