Palmitoyl chloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Principles of method if other than guideline:

Skin irritation was tested using an internal standard method (BASF test). Two White Vienna rabbits were used. One side of the back was treated for 20 h and the other side was treated for 1, 5 or 15 min under occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened with test substance.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Palmitoyl chloride

EC Number:

203-996-7

EC Name:

Palmitoyl chloride

Cas Number:

112-67-4

Molecular formula:

C16H31ClO

IUPAC Name:

hexadecanoyl chloride

Details on test material:

- Name of test material (as cited in study report): Palmitinsaeurechlorid (=Palmitoyl chloride)
- Analytical purity: 98% (analytical report: ZAX96L00731, Jan. 1997)
- Lot/batch No.: Vers. 98
- Lot/batch No.: Vers. 62/V
- Storage condition of test material: room temperature, sensitive to moisture

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Breeder
- Weight at study initiation: 3.25 and 3.54 kg

Test system

Type of coverage:

occlusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): approx. 1 ml

Duration of treatment / exposure:

Experiment 1: 20 h
Experiment 2: 1, 5, or 15 minutes

Observation period:

8 days

Number of animals:

2

Details on study design:

TEST SITE
- Area of exposure: An application site of 2.5 X 2.5 cm was covered with the liquid (37°C; presumably 1 ml)

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
Experiment 1: washing was done in the 1 min, 5 min and 15 min test directly after exposure. Lutrol conc. and 50% (mild detergent) was used.
Experiment 2: No washing was done after the 20 h treatment.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

20 h exposure

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: Necrosis observed in both animals; see table for further details

Results 2

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

20 h exposure

Time point:

24/48/72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 8 d

Remarks on result:

other: see table for further details

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

20 h exposure

Time point:

24/48/72 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: see table for further datails

Results 4

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

20 h exposure

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible within: 7 days

Remarks on result:

other: see table for further datails

Results 5

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

15 min exposure

Time point:

24/48/72 h

Score:

3.67

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: see table for further details

Results 6

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

15 min exposure

Time point:

24/48/72 h

Score:

1.33

Max. score:

2

Reversibility:

fully reversible within:

Remarks:

7 d

Remarks on result:

other: see table for further details

Results 7

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

15 min exposure

Time point:

24/48/72 h

Score:

3.33

Max. score:

4

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: see table for further details

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

15 min exposure

Time point:

24/48/72 h

Score:

1.67

Max. score:

3

Reversibility:

fully reversible within: 7 d

Remarks on result:

other: see table for further details

Any other information on results incl. tables

Since irritation data are recommended for a 4 h skin exposition, results of the available 20 h and the 15 min exposition will serve as approximation.

Descriptive scores of the raw data have been converted to Draize numerical scores. If necroses were reported, erythema scores were given for the surrounding area.

Exposition:	20 h
Animal	Reading	Erythema	Edema	Comment
1	24 h	3	2	anemic necrosis, overlapping 2 finger´s width
2	24 h	3	1
1	48 h	3	2	anemic necrosis, overlapping 2 finger´s width
2	48 h	3	1	white substance deposits
1	72 h	3	2	anemic necrosis, overlapping 2 finger´s width
2	72 h	3	1	white substance deposits
1	4 d	3	2	anemic necrosis
2	4 d	3	1	white substance deposits
1	7 d	2	0	anemic necrosis, surrounding area with scaling
2	7 d	0	0	smooth necrosis
1	8 d	2	0	anemic necrosis, surrounding area with scaling
2	8 d	0	0	smooth necrosis
mean	24 - 72 h	3.00	1.50
1 2	24 - 72 h 24 - 72 h	3.00 3.00	2.00 1.00
Exposition:	15 min
Animal	Reading	Erythema	Edema	Comment
1	24 h	3	0	largely overlapping
2	24 h	3	0	largely overlapping
1	48 h	4	2	largely overlapping
2	48 h	4	2	largely overlapping
1	72 h	4	2	largely overlapping
2	72 h	3	3	largely overlapping
1	4 d	3	2	largely overlapping
2	4 d	3	2	largely overlapping
1	7 d	2	0	rough scaling
2	7 d	0	0	rough scaling
1	8 d	2	0	rough scaling
2	8 d	0	0	rough scaling
mean	24 - 72 h	3.50	1.50
1	24 - 72 h	3.67	1.33
2	24 - 72 h	3.33	1.67