Propyl chloroformate

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, e.g. no details about test substance or applied amount of test substance)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Materials and methods

Principles of method if other than guideline:

Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5 and 15 minutes and 2 other animals for 20 hours using occlusive conditions. An application site of 2.5 X 2.5 cm was covered with the liquid or powdered and moistened test substance.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Propyl chloroformate

EC Number:

203-687-7

EC Name:

Propyl chloroformate

Cas Number:

109-61-5

Molecular formula:

C4H7ClO2

IUPAC Name:

propyl carbonochloridate

Details on test material:

- Name of test material (as cited in study report): n-Propyl-chlorkohlensaeureester
- Physical state: liquid
- Purity: approx. 95%
- 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: 2.8 - 2.9 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:

Experiment 1: up to 8 days
Experiment 2: up to 8 days
(Killing on d 9)

Number of animals:

Experiment 1: 2
Experiment 2: 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:

other: mean (20 h exposure)

Time point:

24 h

Score:

2.5

Max. score:

3

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: red, partially hard necrosis observed in both animals

Results 2

Irritation parameter:

edema score

Basis:

other: mean (20 h exposure)

Time point:

24 h

Score:

1.75

Max. score:

3

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: slight redness observed in 1/2 animals

Results 3

Irritation parameter:

erythema score

Basis:

other: mean (15 min exposure)

Time point:

24 h

Score:

2.5

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: redish, hard necrosis observed in both animals

Results 4

Irritation parameter:

edema score

Basis:

other: mean (15 min exposure)

Time point:

24/48 h

Score:

1

Max. score:

2

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: slight edema observed in both animals

Results 5

Irritation parameter:

erythema score

Basis:

mean

Remarks:

( 20 h exposure)

Time point:

48 h

Score:

2

Max. score:

3

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: red hart necrosis with cross wrinkle

Results 6

Irritation parameter:

edema score

Basis:

mean

Remarks:

(20 h exposure)

Time point:

48 h

Score:

2.5

Max. score:

3

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: red hart necrosis with cross wrinkle

Results 7

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(15 min exposure)

Time point:

48 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: bloody, yellow-brown areas on the whole back

Results 8

Irritation parameter:

edema score

Basis:

mean

Remarks:

(15 min exposure)

Time point:

48 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 d

Remarks on result:

other: bloody, yellow-brown areas on the whole back

Results 9

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(20 h exposure)

Time point:

72 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 10

Irritation parameter:

edema score

Basis:

mean

Remarks:

(20 h exposure)

Time point:

72 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 11

Irritation parameter:

erythema score

Basis:

mean

Remarks:

(15 min exposure)

Time point:

72 h

Reversibility:

not specified

Remarks on result:

not measured/tested

Results 12

Irritation parameter:

edema score

Basis:

mean

Remarks:

(15 min exposure)

Time point:

72 h

Reversibility:

not specified

Remarks on result:

not measured/tested

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	0	anemic necrosis, bloody surrounding area
2	24 h	2	3	overlapping; surrounding white
1	48 h	2	2	red hart necrosis with cross wrinkle
2	48 h	2	3	red pale necrosis
1	5 d	2	2	red hart necrosis with cross wrinkle
2	5 d	2	3	red pale necrosis
1	7 d	2	2	red hart necrosis with cross wrinkle
2	7 d	0	0	necrosis border starts to peel off
1	8 d	2	2	red hart necrosis with cross wrinkle
2	8 d	0	0	necrosis border starts to peel off
mean	24 - 48 h	2.25	2.00
Exposition:	15 min
Animal	Reading	Erythema	Edema	Comment
3	24 h	4	2	skin bloody
4	24 h	1	0	overlaping
3	48 h	4	2	bloody, yellow-brown areas on the whole back
4	48 h	2	2	yellow-brown areas on the whole back
3	5 d	4	3	red-yellow, hard necrosis, surrounding area partially anemic
4	5 d	3	3	pergamentous, redish, hard necrosis
3	7 d	4	3	red-yellow, hard necrosis, surrounding area partially anemic
4	7 d	3	3	pergamentous, redish, hard necrosis
3	8 d	4	3	red-yellow, hard necrosis, surrounding area partially anemic
4	8 d	3	3	pergamentous, redish, hard necrosis
mean	24 - 48 h	2.75	1.50

Applicant's summary and conclusion

Executive summary:

This study meets scientific standards with acceptable restrictions (limited documentation, e.g. no details about test substance). Skin irritation was tested using an internal standard method (BASF test). White Vienna rabbits were used. Usually, 2 animals were treated for 1, 5 and 15 minutes and 2 other animals 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 8 days persistent erythema and necrosis after 15 min and 20 h exposure. The test substance has to be regarded as corrosive.