Registration Dossier

Toxicological information

Skin irritation / corrosion

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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:
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): 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 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

Resultsopen allclose all
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.
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.
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.
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
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.
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.
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.
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:
Sodium Cocoyl Isethionate (83% ai) is slightly irritant to rabbit skin when tested as supplied.
Executive summary:

The skin irritation potential of Sodium Cocoyl Isethionate (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.