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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1992 - 1993
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Qualifier:
according to guideline
Guideline:
EPA OPP 81-5 (Acute Dermal Irritation)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
1-bromo-4-chlorobutane
EC Number:
230-089-3
EC Name:
1-bromo-4-chlorobutane
Cas Number:
6940-78-9
Molecular formula:
C4H8BrCl
IUPAC Name:
1-bromo-4-chlorobutane
Test material form:
liquid
Specific details on test material used for the study:
Product name: TMCB
Chemical name: 1-bromo-4-chlorobutane
Lot No. 0917

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Rosemead Rabbits, Rosemead, Waltham Abbey, Essex, England
- Age at study initiation: Approximately three months old
- Weight at study initiation: 2.69 - 3.22 kg
- Housing:61 cm x 76 cm x 46 cm suspended stainless steel cages.
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least fourteen days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 C (range 15 - 23 C)
- Humidity (%): 55 % R.H. (range: 40% - 70% R.H.)
- Air changes (per hr): 15 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs dark/ 12 hrs light

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.5 ml
Duration of treatment / exposure:
4 hours
Observation period:
Assessment of skin irritation responses at the control and treated test sites were made 1, 24, 48 and 72 hours after removal of the bandages. Additional observations of persistent effects of treatment were made 6, 9, and 12 days after treatment,
Number of animals:
Six rabbits
Details on study design:
TEST SITE
- Area of exposure: 6 x 6 cm
- % coverage: -
- Type of wrap if used: test sample was covered by unmedicated gauze (3 x 2 cm) which was held in place by strips of Blenderm (3-M company).

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Gently washed with warm water and treated with paper towels to remove excess test material adhering to the skin.
- Time after start of exposure:

OBSERVATION TIME POINTS
(indicate if minutes, hours or days)

SCORING SYSTEM:
- Method of calculation:

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
1.3
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Score:
1.8
Max. score:
3
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
2.2
Max. score:
3
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 6 days
Score:
0.7
Max. score:
2
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 9 days
Score:
0
Max. score:
0
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 12 d
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 6 d
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 9 d
Score:
0
Max. score:
0
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 12 d
Score:
0
Max. score:
0

Any other information on results incl. tables

 Very slight, well-defined or moderate erythema was observed at the test sites of all animals during the first 72 hours after bandage removal. Very slight or slight edema was also observed in four animals at the one hour examination. Oss of elasticity was observed in one animal one hour after dosing, in two at the 24 hour examination three at the 48 hour examination and four at the 72 hour examination.

 

During the second week of observation, very slight or well-defined erythema and loss of elasticity were observed in three animals.

Exfoliation was also observed at one of these sites.

 

The test sites of all animals were overtly normal by the twelfth day after treatment,

 

The control sites did not show any response to the control procedure.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the conditions of this test, 1-Bromo-4-chlorobutane (TMCB) was considered to be 'slightly irritant' to the skin.
Executive summary:

Under the conditions of this test, 1-Bromo-4-chlorobutane (TMCB) was considered to be 'slightly irritant' to the skin.