Lauroyl 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:

other: Study meets scientific standards with acceptable restrictions (limited documentation)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1968

Report date:

1968

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

occlusive

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:

Lauroyl chloride

EC Number:

203-941-7

EC Name:

Lauroyl chloride

Cas Number:

112-16-3

Molecular formula:

C12H23ClO

IUPAC Name:

dodecanoyl chloride

Constituent 2

Reference substance name:

XVIII/195

IUPAC Name:

XVIII/195

Details on test material:

- Name of test material (as cited in study report): Laurylsaeurechlorid
- Physical state: liquid
- Purity: unknown
- Expiration date of the lot/batch: not reported
- Stability under test conditions: not reported
- Storage condition of test material: not reported

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: 2.80 and 2.95 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: No washing was done after the 20 h treatment.
Experiment 2: washing was done in the 1 min, 5 min and 15 min test directly after exposure. Lutrol conc. and 50% (mild detergent) was used.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

20 h exposure

Time point:

other: 24 - 48 - 72 h

Score:

2.33

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:

mean

Remarks:

20 h exposure

Time point:

other: 24 - 48 - 72 h

Score:

1.67

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:

mean

Remarks:

15 min exposure

Time point:

other: 24 - 48 - 72 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 8 d

Remarks on result:

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

Results 4

Irritation parameter:

edema score

Basis:

mean

Remarks:

15 min exposure

Time point:

other: 24 - 48 - 72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible

Remarks:

8 d

Remarks on result:

other: see table for further details

Any other information on results incl. tables

Since irritation data from a 4 h skin exposition are recommended, results of the available 20 h and the 15 min exposition served 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	2	2	anemic areas, pergamenteous, wrinkles
2	24 h	2	2	overlapping, pergamenteous, wrinkles
1	48 h	2	2	anemic areas, pergamenteous, wrinkles
2	48 h	2	2	overlapping, pergamenteous, wrinkles, edge anemic
1	72 h	3	0	light brown, smooth and anemic necrosis
2	72 h	3	2	light brown, partly anemic necrosis
1	6 d	?	0	light brown, not smooth necrosis
2	6 d	0	0	light brown, not smooth necrosis
1	8 d	2	0	necrosis, partly detaching
2	8 d	0	0	leather-like necrosis, partly detaching, scaling in the surrounding area
mean	24 - 72 h	2.33	1.67
Exposition:	15 min
Animal	Reading	Erythema	Edema	Comment
1	24 h	2	0	overlapping
2	24 h	2	2	overlapping, pergamenteous
1	48 h	2	0	overlapping, anemic areas
2	48 h	2	2	overlapping, pergamenteous with some pin-head sized anemic areas
1	72 h	2	2	overlapping, anemic areas
2	72 h	2	2	overlapping, pergamenteous with anemic areas
1	6 d	0	0	light, superficial necrosis
2	6 d	0	0	light brown, pergamenteous necrosis
1	8 d	0	0	light, superficial necrosis
2	8 d	0	0	light brown, pergamenteous necrosis, detaching
mean	24 - 72 h	2.00	1.00

Applicant's summary and conclusion

Executive summary:

This study meets scientific standards with acceptable restrictions (limited documentation). Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. 2 animals were treated for 1, 5 and 15 minutes and for 20 hours using occlusive conditions. An application site of 2.5 x 2.5 cm was covered with the test substance.

The test substance induced slight superfacial necrosis after 15 min exposure and full thickness necrosis after 20 h exposure under these harsh occlusive conditions. In conclusion, Lauroyl chloride is classified as corrosive to the skin (R34 according to EU classification criteria and skin corrosion Cat 1C according to GHS classification criteria).