Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliant guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
UK Department of Health, 21 November 2005

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): NExBTL Biodiesel
- Description: Clear colourless liquid
- Date received: 04 July 2006

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Ltd
- Age at study initiation: 12-20 wk
- Weight at study initiation: 2.0 - 3.5 kg
- Housing: individually housed
- Diet (e.g. ad libitum): yes
- Water (e.g. ad libitum): yes
- Acclimation period: 5 d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12 (lights on 0600-1800 hr)


IN-LIFE DATES: From: 18 June 2007 To: 28 June 2007

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Eye not washed or test substance otherwise removed after instillation
Observation period (in vivo):
1, 24, 48 and 72 hr post-treatment
Number of animals or in vitro replicates:
3
Details on study design:
Initially a single animal was used. Test substance (0.1 ml) was instilled into the conjunctival sac of the right eye and the upper and lower eyelids held together for approx. 1 sec before releasing. The left eye was untreated and served as a control. Occular responses were evaluated at 1, 24, 48 and 72 hr post-treatment using Draize criteria. Two additional rabbits were treated subsequently after assessment of treatment-related effects in the first.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: ALL
Score:
0
Max. score:
4
Remarks on result:
other: Score zero at all time points
Irritation parameter:
iris score
Basis:
mean
Time point:
other: ALL
Score:
0
Max. score:
2
Remarks on result:
other: Score zero at all time points
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hr
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24-48 hr
Remarks on result:
other: conjunctival redness present initially in all animals, fully reversed in 24 - 48 hr
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 hr
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 hr
Remarks on result:
other: residual conjunctival redness present in 1 animal, fully reversed in 48 hr
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 hr
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 24 hr
Remarks on result:
other: Chemosis present initially in all animals, fully reversed in 24 hr
Irritation parameter:
other: discharge
Basis:
mean
Time point:
other: 1 hr
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 hr
Remarks on result:
other: Discharge present initially in all animals, fully reversed in 24 hr

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Not irritating to eye
Executive summary:

Eye irritation potential was evaluated in a GLP-compliant guideline study (method B5 of directive 2004/73/EC) using 3 New Zealand White rabbits. The test sample (0.1 ml) was instilled initially into the conjunctival sac of the right eye of one rabbit and the upper and lower eyelids held together for approx. 1 sec. to prevent loss of the sample, then released. The other eye served as a control. Ocular irritation was assessed 1, 24, 48 and 72 hr post-treatment using Draize criteria. After consideration of the responses evoked in the first animal, two additional rabbits were treated in an identical manner. Mild conjunctival redness, chemosis and discharge (all grade 1) were present in all treated eyes at the 1 hr time point but were generally fully resolved by 24 hr. The exception was the occurrence of residual mild conjunctival redness (grade 1) in a single animal at 24 hr (fully resolved by 48 hr). No corneal or iris effects were present in any animal at any time point. Under the conditions of the study NExBTL renewable diesel caused mild, fully reversible eye irritation.