Reaction mass of trimethyl-3-[(1-oxooctadecyl)amino]propylammonium methyl sulphate, Propane-1,2-diol and Trimethyl-3-[(1-oxohexadecyl)amino]propylammonium methyl sulphate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 23th to 30th December 1992

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:

1992

Report date:

1993

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of trimethyl-3-[(1-oxooctadecyl)amino]propylammonium methyl sulphate, Propane-1,2-diol and Trimethyl-3-[(1-oxohexadecyl)amino]propylammonium methyl sulphate

EC Number:

947-471-7

Molecular formula:

C22H47N2O.CH3O4S - C3H8O2 - C24H51N2O.CH3O4S

IUPAC Name:

Reaction mass of trimethyl-3-[(1-oxooctadecyl)amino]propylammonium methyl sulphate, Propane-1,2-diol and Trimethyl-3-[(1-oxohexadecyl)amino]propylammonium methyl sulphate

Test material form:

cream / paste

Remarks:

cream coloured paste

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS:
- Source: David Percival Ltd., Moston, Sandbach, Cheshire, U.K.
- Age at study initiation: approximately twelve to sixteen weeks old
- Weight at study initiation: 2.59 - 2.95 kg
- Housing: individual housing in a suspended metal cage
- Diet: free access throughout the study (RABMA Rabbit Diet, Special Diet Services Ltd., Witham, Essex, U.K.)
- Water: free access throughout the study
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 17 - 20 °C
- Humidity: 42 - 56 %
- Air changes: approximately 15 changes per hour
- Photoperiod: 12 hours light and 12 hours darkness

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Treatment of test material prior to testing: for the purpose of this study the test material was warmed in a water bath prior to use.
- Amount(s) applied (volume or weight with unit): 0.5 ml of the test material was introduced under a 2.5 cm × 2.5 cm gauze patch and placed in position on the shorn skin.

Duration of treatment / exposure:

4 h

Observation period:

up to 7 days after treatment

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: a skin area under a 2.5 cm × 2.5 cm gauze patch
- Type of wrap if used: The patch was secured in position with a strip of surgical adhesive tape (BLENDERM: approximate size 2.5 cm × 4.0 cm). To prevent the animals interfering with the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): gentle swabbing with cotton wool soaked in diethyl ether
- Time after start of exposure: 4 h after application

OBSERVATION TIME POINTS
- 1 hour following the removal of the patch, and 24, 48 and 72 hours later

SCORING SYSTEM:
- The test sites were examined for evidence of primary irritation and scored according to the following scale from Draize J.H. (1959) Association of Food and Drug Officials of the United States, Austin, Texas, "The Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics"
- Method of calculation: the scores for erythema and oedema at the 24 and 72-hour readings were totalled for the three test rabbits (12 values) and this total was divided by 6 to give the primary irritation index of the test material.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible within: 7d

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible within: 7d

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible within: 7d

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7d

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.67

Reversibility:

fully reversible within: 7d

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

1.33

Reversibility:

fully reversible within: 7d

Irritant / corrosive response data:

Very slight erythema was noted at two treated skin sites one hour after patch removal. Very slight to well-defined erythema was noted at all treated skin sites at the 24-hour observation with well-defined erythema at the 48-hour observation and very slight to well-defined erythema at the 72-hour observation.
Very slight to slight oedema was noted at all treated skin sites at the 24 and 48-hour observations with very slight oedema at the 72-hour observation.

Other effects:

Crust formation or desquamation were noted at all treated skin sites 7 days after treatment.

Applicant's summary and conclusion

Interpretation of results:

other: Category 2 (skin irritation) based on criteria in the CLP Regulation (EC 1272/2008).

Conclusions:

Irritant to skin based on crust formation or desquamation noted at all treated skin sites 7 days after treatment.

Executive summary:

The study was performed to assess the irritancy potential of the test item following a single, 4-hour, semi-occluded application to the intact rabbit skin following the OECD guideline 404 (1981).

Very slight erythema was noted at two treated skin sites one hour after patch removal. Very slight to well-defined erythema was noted at all treated skin sites at the 24-hour observation with well-defined erythema at the 48-hour observation and very slight to well-defined erythema at the 72-hour observation.

Very slight to slight oedema was noted at all treated skin sites at the 24 and 48-hour observations with very slight oedema at the 72-hour observation.

Signs of erythema and oedema were all reversible within 7 days.

Crust formation or desquamation were noted at all treated skin sites 7 days after treatment.

Based on effects noted 7 days after treatment, the test item is classified as skin irritant according to the CLP Regulation (EC 1272/2008).