1-bromohexadecane

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

28th June to 30th July 2002

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Study conducted in compliance with agreed protocols, with no deviations from standard test guidelines and no methodological deficiencies, which do not affect the quality of the relevant results. The study report was conclusive, done to a valid guideline and the study was conducted under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

1-bromohexadecane

EC Number:

204-008-7

EC Name:

1-bromohexadecane

Cas Number:

112-82-3

Molecular formula:

C16H33Br

IUPAC Name:

1-bromohexadecane

Details on test material:

- Substance type: White semi-solid block on arrival which melts into a clear colourless viscous liquid.
- Date received: 12th April 2002
- Storage condition of test material: Room temperature in a dark room

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-16 weeks old
- Weight at study initiation: 2.0 to 3.5 kg
- Housing: Individually in suspended metal cages.
- Diet (e.g. ad libitum): Certified Rabbit Diet (Code 5322) supplied by PMI Nutrition International and IPS Product Supplies Limited, ad libitum throughout the study.
- Water (e.g. ad libitum): Mains supplied drinking water ad libitum
- Acclimation period: at least 5 days
- Sex: Male

ENVIRONMENTAL CONDITIONS
- Temperature: 17-23°C
- Humidity: 30-70%
- Air changes: 15 per hr
- Photoperiod (hrs dark / hrs light): 12 hrs light (06:00 - 18:00) then 12 hrs dark.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml

Duration of treatment / exposure:

Total duration of exposure was 4 hours.

Observation period:

1, 24, 48 and 72 hours post exposure, after the patch was removed. The extent of irritation was scored by the Draize scale; any other observed skin reactions were recorded. Observations were made at day 7 and 14 to assess the reversibility of the skin reaction.

Number of animals:

One animal in pre-test and two in the main test.

Details on study design:

PRELIMINARY TEST:
A preliminary study was performed on one rabbit at three sites. One patch was removed at 3 minutes, then 1 hour and finally 4 hours. This was to establish an appropriate exposure time for the main test. Results from the 4 hour exposure are included in the analysis.

MAIN TEST:
There was only one patch site per rabbit in the main test.

TEST SITE
- Area of exposure: 2.5 am x 2.5 cm
- Type of wrap if used: Cotton gauze, secured with surgical adhesive tape. The torso was then wrapped in an elasticated corset, to prevent interference from the animal.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Residual test material was removed by gentle swabbing with cotton wool soaked in 74% Industrial Methylated Spirits or distilled water.
- Time after start of exposure: 4 hours (main test)

SCORING SYSTEM: According to the Draize scale (1977), see field "Any other information on materials and methods incl. tables" for the scoring system. The scores from observations at 24 hrs and 72 hrs were pooled and classified according to table 2 to give an irritant classification. If irreversible alterations were noted, then test material will be classified as corrosive.

Results and discussion

In vivo

Results

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 hrs and 72 hrs post exposure

Score:

3.2

Max. score:

8

Reversibility:

fully reversible

Remarks:

by day 14

Other effects:

No other effects were reported.

Any other information on results incl. tables

Table 3. Results following 4 hour exposure

Skin Reaction	Observation Time	Individual Scores - Rabbit No. And Sex			Total
		80 Male	162 Male	163 Male
Erythema/Eschar Formation	1 hr	2	2	2	(6)
	24 hrs	2	2	2	6
	48 hrs	2	2	2	(6)
	72 hrs	2 Le	1	2 Le	5
	7 days	1	0 D	1 BrCf	(2)
	14 days	0	0	0	(0)
Oedema Formation	1 hr	1	2	2	(5)
	24 hrs	2	2	2	6
	48 hrs	2	1	1	(4)
	72 hrs	1	0	1	2
	7 days	0	0	1	(1)
	14 days	0	0	0	(0)
Sum of 24 and 72 hrs: 19
Primary Irritation Index: 19/6 = 3.2
Classification: Moderate Irritant

( ) = Total value not used for calculation of primary index

Br = Light brown discolouration of the epidermis

Le = Loss of skin elasticity

Cf = Crust formation

D = Slight desquamation

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test the test material was determined to be moderately irritating, scoring a PDII of 3.2 out of 8.

Executive summary:

The skin irritation potential of the test material was determined according to the following guidelines, OECD 404 and EU Method B.4. Three rabbits were exposed to 0.5 ml of the test material for 4 hours; the site was them observed at intervals over a period of 14 days. The test material was determined to be moderately irritating, scoring a PDII of 3.2 out of 8. All observed effects were fully reversible, and skin appeared normal by day 14.

Under the conditions of the test the test material was determined to be moderately irritating and is classified as an Irritant (Xi) and assigned the risk phrase "Irritating to the Skin" (R38) under Directive 2001/59/EC. Under Regulation 1272/2008 the test material should be classed as "Skin Irrit. 2" and assigned the hazard phrase "H315: Causes Irritation to the Skin" and signal word "Warning".