1-bromobutane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28 June 2002- 30 July 2002

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

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)

Version / remarks:

Commision Directive 92/69/EEC

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-bromobutane

EC Number:

203-691-9

EC Name:

1-bromobutane

Cas Number:

109-65-9

Molecular formula:

C4H9Br

IUPAC Name:

1-bromobutane

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: A supplier local to the testing laboratory
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2 - 3.5 kg
- Housing: the animals were individually housed in suspended metal cages
- Diet : certified rabbit diet (code 5322), free access
- Water :certified rabbit diet (code 5322), free access
- Acclimation period: At least 5 days in laboratory conditions.

ENVIRONMENTAL CONDITIONS
-Temperature: (°C) 17-23 ºC
- Humidity (%): 30-70 %
- Air changes (per hr): at least 15 changes per hr.
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: NDA

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
- Concentration (if solution): N/A

VEHICLE
No vehicle used

Duration of treatment / exposure:

One patch was removed at 3 time points: 3 minutes, 1 hour and 4 hours.
Two additional patches were removed after 4 hours.

Observation period:

1 hr, 24, 48 and 72 hrs following removal.

Number of animals:

3 animals.

Details on study design:

TEST SITE
- Area of exposure: NDA
- % coverage: NDA
- Type of wrap if used: sugical adhesive tape. The trunk of the animal was wrapped in an elasticated corset.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): removal by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits.
- Time after start of exposure: N/A

SCORING SYSTEM: Erythema/eschar and oedema.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 2

Irritation parameter:

erythema score

Basis:

mean

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not specified

Results 3

Irritation parameter:

edema score

Basis:

mean

Time point:

24 h

Score:

2.5

Max. score:

4

Reversibility:

not specified

Results 4

Irritation parameter:

edema score

Basis:

mean

Time point:

72 h

Score:

2

Max. score:

4

Reversibility:

not specified

Any other information on results incl. tables

Primary Irritation Index (S/6)= 25/6= 4.2

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test material produced a primary index of 4.2 and was classified as a moderate irritant to rabbit skin according to the Draize classification scheme.

Executive summary:

The test material met the criteria for classification as irritant according to EU labelling Regulation (EC) No 1272/2008. H315: Causes skin irritation is applicable.