Ethyl chloroformate

Skin irritation / corrosion

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: Guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl chloroformate

EC Number:

208-778-5

EC Name:

Ethyl chloroformate

Cas Number:

541-41-3

Molecular formula:

C3H5ClO2

IUPAC Name:

ethyl chlorocarbonate

Details on test material:

- Name of test material (as cited in study report): Ethylchloroformiat
- Analytical purity: not reported
- internal Test substance No. 82/21.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler (Offenbach, Germany).
- Age at study initiation:
- Weight at study initiation: approx. 2.9 kg.
- Housing: 1 rabbit per cage; stainless steel with wire mesh walk floor; walking area 40 cm x 51 cm.
- Diet (e.g. ad libitum): standard diet Ovator Solikanin 4 mm, approx. 130g per animal and day.
- Water (e.g. ad libitum): 250 ml per animal and day of demineralized water (Monday-Friday) or tap water (weekends).
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26°C
- Humidity (%): 30-70%
- Photoperiod (hrs dark / hrs light): 12/12 hrs

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml of the neat test substance;

Duration of treatment / exposure:

1 and 4 hours

Observation period:

7 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: several 3cm x 3cm treatment sites (left and right front and back flanks)
- Type of wrap if used: the tape was fixed with a permeable bandage.
REMOVAL OF TEST SUBSTANCE

- Washing (if done): the skin was rinsed and dried
- Time after start of exposure: after 1 , 4 h, respectively

SCORING SYSTEM: similar to the table contained in OECD TG 404.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72 h

Score:

2.6

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: 1 hour contact

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

1.9

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: 1 hour contact

Results 3

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 - 72 h

Score:

2.8

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: 4 hour contact

Results 4

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 -72 h

Score:

2.2

Max. score:

4

Reversibility:

not reversible

Remarks on result:

other: 4 hour contact

Irritant / corrosive response data:

superfacial necrosis was observe after 1 and afte 4 h semi occlusive exposure to ethychloroformate. The absence of full thickness necrosis was verified by a pathologist. Therefore, EhCF is extremely irritating but not corrosive in this study.

Other effects:

Pathology: after sacrifice the animals were subjected to gross pathology. If there were signs of necroses, these were confirmed by gross pathologicalexamination after incision of the skin.

Any other information on results incl. tables

(1) Skin reactions (means of 6 animals) following the 1-hr

                  occlusive contact period were as follows:

                  --------------------------------------------

                  Examination          Skin reaction

                                  ER        ED        Remarks

                  --------------------------------------------

                  1 hour         2.17      2.83         N

                  24 hours      2.17      2.5         N

                  48 hours      2.67      1.67        N

                  72 hours      2.67      1.83        N

                  7 days         3.67      1.5        N

                  --------------------------------------------

                  ER=erythema, ED=edema,  N=necrosis

Erythema and edema extended beyond the exposure area in all animals at all readings.

Superficial necroses were seen in 1/6 animals at 48 h post application, and in 5/6 animals at the end of the observation period, 7 days after application.

(2) Skin reactions (means of 6 animals) following the 4-hr

                  occlusive contact period:

                  --------------------------------------------

                  Examination          Skin reaction

                                  ER        ED        Remarks

                  --------------------------------------------

                  1 hour          2.50      3.33      N

                  24 hours       2.50      2.50      N

                  48 hours       2.83      2.33      N

                  72 hours       3.17      1.83      N

                  7 days          4.0       1.50       N

                  --------------------------------------------

                  ER=erythema, ED=edema,  N=necrosis

Erythema and edema extended beyond the exposure area in all animals at all readings.

Superficial necroses were seen in one animals (1/6) as early as 1 h after patch removal and in all animals (6/6) at the end of the observation period, 7 days after treatment.