Fatty acids, C12-18 (even numbered)-methyl esters, sulfonated, sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

6th January - 9th January 1994

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

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)

Version / remarks:

Commission Directive 92/69/EEC

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Fatty acids, C12-18, α-sulfo, 1-Me esters, sodium salts

EC Number:

288-224-7

EC Name:

Fatty acids, C12-18, α-sulfo, 1-Me esters, sodium salts

Cas Number:

85681-86-3

Molecular formula:

C13H25NaO5S - C19H37NaO5S

IUPAC Name:

Fatty acids, C12-18, α-sulfo, 1-Me esters, sodium salts

Constituent 2

Reference substance name:

Fatty acids, C12-18, α-sulfo, disodium salts

EC Number:

286-085-7

EC Name:

Fatty acids, C12-18, α-sulfo, disodium salts

Cas Number:

85186-99-8

Molecular formula:

C12H22Na2O5S - C18H34Na2O5S

IUPAC Name:

Fatty acids, C12-18,α-sulfo, disodium salts

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, UK
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.41-2.51 kg
- Housing:Individually housed in suspended metal cages.
- Diet: ad libitum - STANRAB SQC Rabbit Diet, Special Diets Services Ltd, Witham, Essex, UK
- Water: ad libitum
- Acclimation period: minimum of 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-19
- Humidity (%): 44-49
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light):12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

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

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- % coverage: no data
- Type of wrap if used: 2.5 cm x 2.5 cm gauze patch, secured in position with a strip of surgical adhesive tape (BLENDERM; 2.5 cm x 4 cm) and then the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) one hour after removal of patches and 24, 48 and 72 hours later.

SCORING SYSTEM:
- Method of calculation: Draize scale

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Very slight erythema was noted at all treated skin sites one and 24 hours after patch removal and at one treated skin site at the 48-hour observation. Very slight oedema was noted at two treated skin sites one hour after patch removal.

Refer to Table 1 below for individual scores.

Other effects:

none

Any other information on results incl. tables

Table 1: Individual skin reactions

Skin Reaction	Observation Time (Hours)	Individual scores – Rabbit Number and Sex			Total
		109 Female (2.47)	126 (Male (2.51)	129 Female (2.41)
Erythema/Eschar Formation	1	1	1	1	3
	24	1	1	1	3
	48	1	0	0	1
	72	0	0	0	0
Oedema Formation	1	0	1	1	2
	24	0	0	0	0
	48	0	0	0	0
	72	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the results of this study, the test item is not classified for skin irritation.

Executive summary:

In a study performed according to OECD TG 404 and EU Method B.4, the test item, moistened with water, was applied to the clipped backs of three New Zealand White rabbits under semi-occlusive conditions for 4 hours. After 4 hours, any remaining test item was removed by gently swabbing the skin with cotton wool soaked with distilled water. Approximately one hour after removal of patches and 24, 48 and 72 hours later, the test sites were examined for evidence of primary irritation and scored according to the Draize scale. Very slight erythema was noted at all treated skin sites one and 24 hours after patch removal and at one treated skin site at the 48-hour observation. In all cases, no effects were noted after 72 hours. Very slight oedema was noted at two treated skin sites one hour after patch removal, but was not present by the 24 hour observation. On the basis of this study, the test item is not classified for skin irritation.