1-chlorobutane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

April 1989

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP-guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1989

Report date:

1989

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

Deviations:

yes

Remarks:

occlusive coverage; no further observations after 72 h to establish reversibility

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

1-chlorobutane

EC Number:

203-696-6

EC Name:

1-chlorobutane

Cas Number:

109-69-3

Molecular formula:

C4H9Cl

IUPAC Name:

1-chlorobutane

Details on test material:

- Name of test material (as cited in study report): N-Butylchlorid
- Storage condition of test material: at 5°C (+/- 2°C)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harald Schriever, Kaninchenfarm, Bremervörde, Germany
- Weight at study initiation: 2.4 - 2.8 kg
- Housing: individually (cages: 40 cm x 45 cm x 50 cm)
- Diet: ad libitum
- Water: ad libitum tap water; analysed regularly
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 2
- Humidity (%): 50 -85
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: March, 21th 1989 To:

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

other: skin areas without test substance

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL is directly applied to skin
- Concentration (if solution): undiluted (pH 6.5)

Duration of treatment / exposure:

4 hours

Observation period:

30 - 60 min, 24 h, 48 h and 72 h

Number of animals:

6

Details on study design:

TEST SITE
- Area of exposure: left scarified and shaved dorsal area and right shaved (but not scarified) dorsal area of the trunk; the sacrified area was not taken into account for assessment of skin irritation potential
- % coverage: 2.5 x 2.5 cm
- Type of wrap if used: "Kosmoplast" and "Elastoplast" (breathable) patches and additional wrapping of the trunk with "Stülpa"

REMOVAL OF TEST SUBSTANCE
- Washing (if done): with tepid water
- Time after start of exposure: 4 hours

SCORING SYSTEM: according to guideline (Draize scores)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

other: average over 24 h/48 h/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

other: average over 24 h/48 h/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

other: average over 24 h/48 h/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72h

Results 4

Irritation parameter:

erythema score

Basis:

animal #4

Time point:

other: average over 24 h/48 h/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 5

Irritation parameter:

erythema score

Basis:

animal #5

Time point:

other: average over 24 h/48 h/72 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 6

Irritation parameter:

erythema score

Basis:

animal #6

Time point:

other: average over 24 h/48 h/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 7

Irritation parameter:

edema score

Basis:

animal #1

Time point:

other: average over 24 h/48 h/72 h

Score:

1.67

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 8

Irritation parameter:

edema score

Basis:

animal #2

Time point:

other: average over 24 h/48 h/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 9

Irritation parameter:

edema score

Basis:

animal #3

Time point:

other: average over 24 h/48 h/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 10

Irritation parameter:

edema score

Basis:

animal #4

Time point:

other: average over 24 h/48 h/72 h

Score:

1

Max. score:

4

Reversibility:

not fully reversible within: 72 h

Results 11

Irritation parameter:

edema score

Basis:

animal #5

Time point:

other: average over 24 h/48 h/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 12

Irritation parameter:

edema score

Basis:

animal #6

Time point:

other: average over 24 h/48 h/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Any other information on results incl. tables

Erythema formation scores (max. score 4) for each animal at the time points 24, 48 and 72 hours after patch removal

Animal No.	24 hours		48 hours		72 hours		Mean value from gradings at 24, 48 and 72 hours
	test substance	control	test substance	control	test substance	control	Test substance
1	2	0	2	0	1	0	1.67
2	1	0	1	0	1	0	1
3	1	0	1	0	0	0	0.67
4	2	0	2	0	1	0	1.67
5	1	0	1	0	0	0	0.67
6	0	0	0	0	0	0	0

Oedema formation scores (max. score 4) for each animal at the time points 24, 48 and 72 hours after patch removal

Animal No.	24 hours		48 hours		72 hours		Mean value from gradings at 24, 48 and 72 hours
	test substance	control	test substance	control	test substance	control	Test substance
1	2	0	2	0	1	0	1.67
2	0	0	0	0	0	0	0
3	0	0	0	0	0	0	0
4	1	0	1	0	1	0	1
5	0	0	0	0	0	0	0
6	0	0	0	0	0	0	0

 

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS