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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 guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
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

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
8
Max. score:
20
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
20
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 72 hours
Score:
0
Max. score:
10
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.

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