Fatty acids, C12-18 and C18-unsatd., 2-sulfoethyl esters, sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1983-04-26 to 1983-06-10

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Not conducted according to GLP or OECD gudeline but equivalent to OECD guideline 404, with modified scoring scheme. Test substance (Fenopon AC798) idetfied in study report as Sodium Lauryl isethionate.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

Scoring system for skin irritation is based on a scale of 0-7 not 1-5 but is equivalent to Draise.

GLP compliance:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Details on test material:

- Name of test material (as cited in study report): Fenopon AC78 (sodium Cocoyl Isethionate)
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not applicable
- InChl (if other than submission substance): not applicable
- Structural formula attached as image file (if other than submission substance): not applicable
- Substance type: organic
- Physical state: Solid
- Analytical purity: 83% Sodium Lauryl Isethionate
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: Sodium Lauryl Isethionate, 83%
- Isomers composition: Sodium Lauryl Isethionate
- Purity test date: No information
- Lot/batch No.: No data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: no data
- Age at study initiation: 9-12 weeks
- Weight at study initiation: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum):no data
- Acclimation period: no data


ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data


IN-LIFE DATES: no data

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.2g test solid (83% active) applied to a moistened patch
- Concentration (if solution): not applicable


VEHICLE
not applicable, test material applied as a solid

Duration of treatment / exposure:

4 hours

Observation period:

4, 24, 48 & 72 hours after treatment

Number of animals:

8 per group

Details on study design:

TEST SITE
- Area of exposure: dorsal surface
- % coverage: no data
- Type of wrap if used: cotton gauze under zinc oxide plaster under thin, flexible polythene wrap


REMOVAL OF TEST SUBSTANCE
- Washing (if done): none (treatment sites wiped clean of excess test material upon removal of patches)
- Time after start of exposure: 4 hours


SCORING SYSTEM: 8-point scale ranging from "a" (very slight) to "h" (severe)

Insert table of overall test scoring system (p. 13)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 4 h

Score:

>= 1

Max. score:

1

Reversibility:

no data

Remarks on result:

other: Mean score for 8 animals.

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 4 h

Score:

>= 1

Max. score:

1

Reversibility:

no data

Remarks on result:

other: Mean score for 8 animals.

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 h

Score:

>= 1.3

Max. score:

2

Reversibility:

no data

Remarks on result:

other: Mean score for 8 animals.

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 h

Score:

>= 1

Max. score:

1

Reversibility:

no data

Remarks on result:

other: Mean score for 8 animals

Results 5

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 48 h

Score:

>= 0.9

Max. score:

1

Reversibility:

no data

Remarks on result:

other: Mean score for 8 animals.

Results 6

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 48 h

Score:

>= 0.9

Max. score:

1

Reversibility:

no data

Remarks on result:

other: Mean score for 8 animals.

Results 7

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 72 h

Score:

>= 0.6

Max. score:

1

Reversibility:

fully reversible within: 3 out of 8 animals

Remarks on result:

other: Mean score for 8 animals.

Results 8

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 72 h

Score:

>= 0.4

Max. score:

1

Reversibility:

fully reversible within: 5 out of 8 animals

Remarks on result:

other: Mean score for 8 animals.

Any other information on results incl. tables

Table 1: Summary of Skin Irritation Results

Rabbit No.	4 hours		24 hours		48 hours		72 hours
	Er*	Oe**	Er	Oe	Er	Oe	Er	Oe
351	1	1	2	1	1	1	1	1
356	1	1	1	1	1	1	0	0
359	1	1	1	1	1	1	0	0
385	1	1	1	1	1	1	1	0
398	1	1	1	1	1	1	1	0
400	1	1	1	1	0	0	0	0
401	1	1	1	1	1	1	1	1
404	1	1	2	1	1	1	1	1
Mean	1	1	1.3	1	0.9	0.9	0.6	0.4

*Erythema

**Oedema

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Fenopon AC78 (83% ai) is slightly irritant to rabbit skin when tested as supplied.

Executive summary:

The skin irritation potential of Fenopon AC78 (83%ai) was studied in an in vivo rabbit skin irritation study.

Fenopon AC78 (83% ai) is slightly irritant to rabbit skin when tested as supplied.