2-ethylhexyl 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:

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

Data source

Reference

Title:

Unnamed

Year:

1968

Report date:

1968

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. Differences to OECD TG 404 (exposure time, occlusive dressing)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-ethylhexyl chloroformate

EC Number:

246-278-9

EC Name:

2-ethylhexyl chloroformate

Cas Number:

24468-13-1

Molecular formula:

C9H17ClO2

IUPAC Name:

2-ethylhexyl carbonochloridate

Details on test material:

- Name of test material (as cited in study report): 2-Ethylhexylchlorformiat (2-ethylhexylchloroformate)
- Physical state: liquid
- Analytical purity: 99%
- Impurities (identity and concentrations): phosgene and Di-2ethylhexylcarbonate
- Storage condition of test material: dry, cool, in glas containers
- Sability under storage conditions > 2 years

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler, Offenbach, Germany
- Weight at study initiation: 2.88 kg (F); 2,76 kg (m)
- Housing: single
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

ENVIRONMENTAL CONDITIONS
not reported

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 500 µl

Duration of treatment / exposure:

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

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

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM:
Similar to the Draize scoring system of OECD TG 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

20 h occlusie

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: 20 h occlusie

Results 2

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

20 h occlusive

Time point:

48 h

Score:

2

Max. score:

2

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: 20 h occlusive

Results 3

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

20 h occlusive

Time point:

48 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 20 h occlusive

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

20 h occlusive

Time point:

24 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 20 h occlusive

Results 5

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

20 h occlusive

Time point:

24 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: 20 h occlusive

Results 6

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

20 h occlusive

Time point:

48 h

Score:

3

Max. score:

3

Reversibility:

not fully reversible within: 8 days

Remarks on result:

other: 20 h occlusive

Results 7

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

20 h occlusive

Time point:

24 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 20 h occlusive

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

20 h occlusive

Time point:

48 h

Score:

2

Max. score:

2

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 20 h occlusive

Results 9

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

15 min occlusive

Time point:

24 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within:

Remarks:

8 days

Remarks on result:

other: 15 min occlusive

Results 10

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

15 min occlusive

Time point:

48 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 15 min occlusive

Results 11

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

15 min occlusive

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

other: 15 min occlusive

Results 12

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

15 min occlusive

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

other: 15 min occlusive

Results 13

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

15 min occlusive

Time point:

24 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 15 min occlusive

Results 14

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

15 min occlusive

Time point:

48 h

Score:

3

Max. score:

3

Reversibility:

fully reversible within: 8 days

Remarks on result:

other: 15 min occlusive

Results 15

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

15 min occlusive

Time point:

24 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

other: 15 min occlusive

Results 16

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

15 min occlusive

Time point:

48 h

Score:

0

Max. score:

0

Reversibility:

not specified

Remarks on result:

other: 15 min occlusive

Results 17

Irritation parameter:

erythema score

Basis:

mean

Remarks:

20 h occlusive

Time point:

72 h

Remarks on result:

not measured/tested

Remarks:

20 h occlusive

Results 18

Irritation parameter:

edema score

Basis:

mean

Remarks:

20 h occlusive

Time point:

72 h

Remarks on result:

not measured/tested

Remarks:

20 h occlusive

Results 19

Irritation parameter:

erythema score

Basis:

mean

Remarks:

15 min occlusive

Time point:

72 h

Remarks on result:

not measured/tested

Remarks:

15 min occlusive

Results 20

Irritation parameter:

edema score

Basis:

mean

Remarks:

15 min occlusive

Time point:

72 h

Remarks on result:

not measured/tested

Remarks:

15 min occlusive

Irritant / corrosive response data:

sever irritant (for detailed results see remarks on results below)

Any other information on results incl. tables

Descriptive scores of the raw data have been converted to Draize numerical scores.

Exposure	20h
Animal	Reading	Erythema	Edema	Comment
1	24 h	2	3
1	48 h	2	3
1	8 d	2	0	moderate to strong eschar formation
mean	24-48 h	2	3
2	24 h	3	2
2	48 h	3	2
2	8 d	2	0	moderate to strong eschar formation
mean	24-48 h	3	2
Exposure	15 min
Animal	Reading	Erythema	Edema	Comment
1	24 h	3	0
1	48 h	3	0
1	8 d	0	0	moderate to strong eschar formation
mean	24-48 h	3	0
2	24 h	3	0
2	48 h	3	0
2	8 d	0	0	moderate to strong eschar formation
mean	24-48 h	3	0
Exposure	5 min
Animal	Reading	Erythema	Edema	Comment
1	24 h	3	0
1	48 h	3	0
1	8 d	0	0	moderate to strong eschar formation
mean	24-48 h	3	0
2	24 h	3	0
2	48 h	3	0
2	8 d	0	0	moderate to strong eschar formation
mean	24-48 h	3	0
Exposure	1 min
Animal	Reading	Erythema	Edema	Comment
1	24 h	3	0
1	48 h	3	0
1	8 d	0	0	moderate to strong eschar formation
mean	24-48 h	3	0
2	24 h	3	0
2	48 h	3	0
2	8 d	0	0	moderate to strong eschar formation
mean	24-48 h	3	0

Applicant's summary and conclusion

Conclusions:

2-Ethylhexylchloroformates is irritating to the skin.

Executive summary:

Undiluted 2-ethylhexanoylchloride (0.5 mL) was applied onto the skin of shaved White Vienna rabbits. Two animals were treated for 1, 5 and 15 minutes and 2 other animals for 20 hours using occlusive conditions. Erythema (24 h score 3/4) was observed following a 15-min occlusive exposure. Erythema (up to score 3) and edema (up to score 3) were observed after a 20 h exposure. For 20 h exposure, erythema (score 2) was still visible 8 days after treatment. The overall primary irritation score (intact skin) was 5.0/8.0 (20 h exposure) and 3/8.0 (15 min exposure), which was consistent with a rating of moderately irritating in both cases.