1-bromohexadecane

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1st to 9th August 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 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye 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: Received as a semi-solid block, which melts into a clear colourless viscous liquid.
- Date received: 12th April 20002
- Storage condition of test material: Room temperature in the dark

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: David Percival Ltd, Moston, Sandbach, Cheshire, UK
- Age at study initiation: 12-20 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 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

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

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Volume applied: 0.1ml

Observation period (in vivo):

- Observations were made at approximately 1, 24, 48, and 72 hours post exposure.

Number of animals or in vitro replicates:

Three animals were used, one from the pre-test and two from the main test.

Details on study design:

PRELIMINARY TEST
- One rabbit was exposed in the right eye, with the contralateral acting as a control. The test material was administered into the conjunctival sac, formed by gently pulling the lower lid away from the eyeball. The eye lid was held for one second before the animal was released.
- Initial pain reaction was judged from this application and scored according to a 6 point scale, which can be seen in table 1 in the field "Any other information on materials and methods incl. tables".
- The ocular response was used to judge the number of animals necessary for main test.

MAIN TEST
- Two animals were exposed in one eye, with the other acting as a control.
- Local anaesthetic was used to minimise the pain, administered 1-2 minutes before exposure (Amethocaine hydrochloride 0.5% Chauvin Pharmaceuticals).
- Examination was aided by the use of a light source form a standard ophthalmoscope.
- Response was scored according to the Draize scale (1977), which can be seen in table 2 in the field "Any other information on materials and methods incl. tables".
- Any other ocular effects were also noted.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 1 hour

Score:

8

Max. score:

20

Reversibility:

fully reversible within: 24 hours

Results 2

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

20

Results 3

Irritation parameter:

iris score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

10

Results 4

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

other: 72 hours

Score:

0

Max. score:

80

Other effects:

No corneal or iridial effects were recorded.
Moderate conjunctival irritation was noted in all treated eyes one hour after treatment.
All treated eye were normal at 24 hour observation.

Any other information on results incl. tables

Table 3. Individual Total Scores and group Mean Scores for Ocular Irritation

Rabbit Number and Sex	Individual Total Scores At:
	1 Hour	24 Hours	48 Hours	72 Hours
120 Male	8	0	0	0
106 Female	8	0	0	0
36 Male	8	0	0	0
Group Total	24	0	0	0
Group Mean Score	8.0	0.0	0.0	0.0

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of the test, the test material was classified as none irritating. Conjunctivae irritation observed at 1 hour fully reversed within 24 hours. No other irritation was observed.

Executive summary:

The ocular irritation of the test material was determined according to the following guidelines; OECD 405 and EU Method B.5. Three New Zealand White rabbits were exposed to 0.1 ml of the test material and observed over a 72 hour period. The test material caused sufficient pain when administered that a local anaesthetic was used. Under the conditions of the test moderate conjunctiva irritation was observed at 1 hour being scored 8 out of 20 according to the Draize scale (1977). This was fully reversible within 24 hours. No other ocular effects were noted over the 72 hour observation period.

According to Regulation 1272/2008 the test material does not require classification as an eye irritant.