Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report date:
1998

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Acid chlorides, coco
EC Number:
269-133-1
EC Name:
Acid chlorides, coco
Cas Number:
68187-89-3
Molecular formula:
variable
IUPAC Name:
dodecanoyl chloride; tetradecanoyl chloride
Constituent 2
Reference substance name:
Fatty acids, coco, chlorinated
EC Number:
307-160-3
EC Name:
Fatty acids, coco, chlorinated
Cas Number:
97553-06-5
IUPAC Name:
97553-06-5
Constituent 3
Reference substance name:
Cocoyl chloride
IUPAC Name:
Cocoyl chloride
Constituent 4
Reference substance name:
96/239
IUPAC Name:
96/239
Details on test material:
- Name of test material (as cited in study report): Kokosfettsaeurechlorid)
- Batch No.: Vers. 148/U
- Physical state: clear liquid, yellowish
- Analytical purity: 99.5 % (by GC)
- Expiration date of the lot/batch: not reported
- Stability under test conditions: confirmed by the analytical report 98L00389 as stated in the 1st amendment
- Storage condition of test material: at room temperature under exclusion of moisture and oxygen (nitrogen atmosphere)

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Dr. K. Thomae GmbH, Biberach (Germany)
- Age at study initiation: young adult
- Weight at study initiation: 3.84 - 4.00 kg
- Housing: single
- Diet: Kliba Labordiaet 341 (Klingentalmuehle AG, Kaiseraugst, CH) ca. 130 g per day
- Water: tap water ca. 250 mL per day
- Acclimatization: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12/ 12

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5 mL
Duration of treatment / exposure:
4 h
Observation period:
15 d
Number of animals:
3 (males only)
Details on study design:
TEST SITE
- Area of exposure: upper third of the back or flanks
- Type of wrap if used: Idealbinde, Pfaelzische Verbandstoff-Fabrik, Kaiserslautern, Germany, and Fixomull stretch (adhesive fleece), Baiersdorf AG, Hamburg, Germany


REMOVAL OF TEST SUBSTANCE
- Washing: Lutrol and Lutrol/Water 1:1


SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 15 d
Remarks on result:
other: partially severe scaling observed; see table for details
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24 - 48 - 72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 15 d
Remarks on result:
other: see table for details

Any other information on results incl. tables

Exposition:

4 h

Animal

Reading

Erythema

Edema

Symptoms

1

1 h

3

2

Erythema and edema extending beyond the area of exposure

2

1 h

3

1

Erythema and edema extending beyond the area of exposure

3

1 h

3

1

Erythema and edema extending beyond the area of exposure

1

24 h

4

2

Erythema and edema extending beyond the area of exposure

2

24 h

4

2

Erythema and edema extending beyond the area of exposure

3

24 h

4

2

Erythema and edema extending beyond the area of exposure

1

48 h

4

2

Erythema and edema extending beyond the area of exposure

2

48 h

4

2

Erythema and edema extending beyond the area of exposure

3

48 h

4

3

Erythema and edema extending beyond the area of exposure

1

72 h

4

2

Erythema and edema extending beyond the area of exposure

2

72 h

4

3

Erythema and edema extending beyond the area of exposure

3

72 h

4

3

Erythema and edema extending beyond the area of exposure

1

8 d

4

1

Erythema and edema extending beyond the area of exposure

2

8 d

2

1

Erythema and edema extending beyond the area of exposure, superficial scabbing

3

8 d

2

1

Erythema and edema extending beyond the area of exposure, superficial scabbing

1

15 d

1

0

Erythema and severe scaling extending beyond the area of exposure

2

15 d

0

0

Severe scaling extending beyond the area of exposure

3

15 d

1

0

Erythema and scaling extending beyond the area of exposure

mean

24 - 72 h

4.00

2.33

 

Applicant's summary and conclusion

Executive summary:

The study was performed according to OECD guideline 404 and GLP requirements and is reliable without restrictions. A cloth (2.5 x 2.5 cm) soaked with 0.5 mL of unchanged test substance was applied on the clipped skin of three rabbits under semiocclusive conditions. After 4 h the test substance was washed away. Application of the test substance for 4 h caused severe erythema, which were not fully reversible in 2/3 animals and slight to moderate edema which were fully reversible within 15 d. Partially severe scaling was observed.

Conclusion

Following the conditions of the test, cocoyl chloride has to be considered as irritating to the skin