3,4-dichlorobut-1-ene

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

other information

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study. Adopted according to OECD SIDS (public available peer reviewed source). The original source is available and has been reviewed.

Data source

Reference

Reference 1

Reference Type:

study report

Title:

Unnamed

Year:

1999

Reference 2

Reference Type:

secondary source

Title:

SIDS Initial Assessment Report for 11th SIAM

Author:

OECD SIDS

Year:

2003

Bibliographic source:

UNEP Publications

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,4-dichlorobut-1-ene

EC Number:

212-079-0

EC Name:

3,4-dichlorobut-1-ene

Cas Number:

760-23-6

Molecular formula:

C4H6Cl2

IUPAC Name:

3,4-dichlorobut-1-ene

Details on test material:

- Name of test material (as cited in study report): 3,4-dichlorbuten-1
- Substance type: product
- Physical state: liquid
- Analytical purity: apporx. 99%
- Batch No.: PE 482
- Stability under test conditions: until 27.07.2002
- Storage condition of test material: at room temperature

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology JG, Löhndorf, Post Wankendorf; Germany
- Age at study initiation: approx. 4 to 4.5 months
- Weight at study initiation: 2.0-2.5 kg
- Housing: During the exposure period the animals were kept singly in special restrainers which allowed free movement of the head but prevented a complete body turn. Before and after the 4-hour exposure period the rabbits were kept separately in cages with dimensions of 425 mm x 600 mm x 380 mm.
- Diet (e.g. ad libitum): Altromim 2023 (Altromin GmbH, D-32791 Lage/Lippe, Germany) was served as feed. The feed was available ad libitum before and after the exposure period.
- Water (e.g. ad libitum): The tap water was offered ad libitum before and after the exposure period.
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3
- Humidity (%): 50 ± 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin sites serve as control

Amount / concentration applied:

undiluted
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL /patch and animal

Duration of treatment / exposure:

4 hour(s)

Observation period:

4 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm²
- Type of wrap if used: Gauze Patch which was held in contact with the skin by means of semiocclusive dressing for the duration of the exposure period.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not reported


SCORING SYSTEM: Draize

EXAMINATION OF THE SKIN: the skin sites were evaluated immediately before the application of the test substance. After 4-hour exposure period the patch was removed and the skin sites were evaluated. Scores were taken 60 minutes, 24, 48, 72 hours and 4 days after patch removal.
Based on most recent guidelines the skin reactions are monitored until the changes observed have completely subsided, however for not more than 14 days after application. Animals that do not reveal any lesions anymore for 24 hours following the first 72 hours of observation are sacrificed.

GENERAL CRITERIA: body weight of all animals was measured at the beginning of the study.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

1.33

Max. score:

4

Reversibility:

fully reversible within: 4 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: 24, 48 and 72 hours

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 hours

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: 24, 48, and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

Under the test conditions all three rabbits exposed for 4 hours to 0.5 mL 3,4-dichlorobuten-1/patch/animals (semiocclusive condition) showed erythema: animal no. 1 showed 60 minutes to 48 hours after patch removal grade 1erythema ; animal no. 2 showed 60 minutes to 24 hours after patch removal grade 2 erythema and 48 to 72 hours after patch removal grade 1 erythema; animal no. 3: showed 60 minutes to 24 hours after patch removal grade 2 erythema and 48 hours after patch removal grade 1 erythema.
There were no systemic intolerance reactions.
4 days after the treatment all the skin findings were completely gone.

Any other information on results incl. tables

Table 1. : Individual skin examination scores after 4h-exposure to 3, 4-dichlorobut-1 -ene.

Skin effect	Erythema				Edema
Scoring	24h	48h	72h	Mean (of 24, 48 and 72 hours in intact skin)	24h	48h	72h	Mean (of 24, 48 and 72 hours in intact skin)
Animal No. / Sex
1	1	1	0	0.67	0	0	0	0
2	2	1	1	1.33	0	0	0	0
3	2	1	0	1.00	0	0	0	0

Based on the test results the test substance is not to be classified according to DSD-DPD and CLP criteria.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: other: DSD-DPD and CLP

Executive summary:

Bayer AG (1999)

In a primary dermal irritation study, the skin irritation/corrosion potential of 3,4-dichlorobut-1-ene was tested. The shaved dorsal skin of the trunk of three male Himalayan rabbits was exposed to 0.5 mL test material for 4 hours under semi-occlusive conditions (OECD guideline 404; EC guideline B.4.). The rabbits were observed for 4 days. Skin reactions were assessed using the Draize scheme approx. 1, 24, 48, 72 hours and 4 days after removal of the test substance.

Under the test conditions all three rabbits exposed for 4 hours to 0.5 mL 3,4-dichlorobuten-1/patch/animals (semiocclusive condition) showed erythema: animal no. 1 showed 60 minutes to 48 hours after patch removal grade 1erythema ; animal no. 2 showed 60 minutes to 24 hours after patch removal grade 2 erythema and 48 to 72 hours after patch removal grade 1 erythema; animal no. 3: showed 60 minutes to 24 hours after patch removal grade 2 erythema and 48 hours after patch removal grade 1 erythema.

There were no systemic intolerance reactions. 4 days after the treatment all the skin findings were completely gone.

On the basis of the present information, it can be concluded that 3,4-dichlorobut-1-ene is not irritating to skin. Therefore the test substance is not to be classified according to DSD-DPD and CLP criteria.