Reaction mass of 1-chlorobut-2-ene and 3-chlorobut-1-ene

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:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

no

GLP compliance:

no

Remarks:

study prior to GLP requirements

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of (E)-1-chlorobut-2-ene and 3-chlorobut-1-ene

EC Number:

908-820-9

Molecular formula:

not applicable

IUPAC Name:

Reaction mass of (E)-1-chlorobut-2-ene and 3-chlorobut-1-ene

Specific details on test material used for the study:

Purity: 99.9 %

Test animals

Species:

rabbit

Strain:

other: White Russian

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:Fa. Dr. Karl Thomae GmbH, Biberach, Germany
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: individually
- Diet: ad libitum, K12, Ssniff, Germany
- Water ad libitum
- Acclimation period: 14 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 1°C
- Humidity (%): 60 + 5%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

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
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 h exposure time, after 4h, dressing was removed and skin was washed with water

Observation period:

up to 21 days

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: 6 cm2
- % coverage:
- Type of wrap if used: gauze and polyethxlen foil, fixed with elastic bandage


REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, water
- Time after start of exposure: 4h


SCORING SYSTEM: OECD Guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

3.3 - 4

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: dark brown-reddish, hard scab or thinner eschar formation. From day one fur growth, from day 13. day detaching of the scab from outer side

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

1.33 - 2

Max. score:

4

Reversibility:

not fully reversible within: 21 days

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48, 72 h

Score:

5.21

Max. score:

8

Reversibility:

not fully reversible within: 21 days

Remarks on result:

other: single means: 1h: 4.67, 24h: 4.17; 48h: 6.0, 72h: 6.0

Irritant / corrosive response data:

after 48h to 72h post exposure, erythema score 4 were observed in all animals
dark brown-reddish, hard scab or thinner eschar formation. From day one fur growth, from day 13. day detaching of the scab from outer side

Other effects:

no systemic effects were reported

Applicant's summary and conclusion

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Conclusions:

Under conditions tested, the test substance showed severe effects on the skin after 4h exposure and is therefore considered to be corrosive.