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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
28 September 2007 to 01 November 2007
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

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

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)
Version / remarks:
Commission Directive 2004/73/EC
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
(Date of inspection: 21 August 2007 Date of Signature: 15 October 2007)

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
417-560-0
EC Name:
-
Cas Number:
67881-98-5
Molecular formula:
C11H22NO6P
IUPAC Name:
trimethyl[2-({2-[(2-methylprop-2-enoyl)oxy]ethyl phosphonato}oxy)ethyl]azanium
Details on test material:
- Name of test material (as cited in study report): MPC
- Substance type: White powder
- Physical state: Solid
- Lot/batch No.: 270103 (received on 14 September 2007)
- Storage condition of test material: Approximately 4ºC in the dark until 26 October 2007, thereafter approximately 4ºC in the dark over silica gel.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan UK Limited, Bicester, Oxon, United Kingdom.
- Age at study initiation: 12 to 20 weeks old.
- Weight at study initiation: 2.0 to 3.5 kg.
- Housing: The animals were individually housed in suspended cages.
- Diet (e.g. ad libitum): Certified Rabbit Diet ad libitum throughout the study.
- Water (e.g. ad libitum): Mains drinking water ad libitum throughout the study.
- Acclimation period: At least 5 days.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23°C
- Humidity (%): 30 to 70%
- Air changes (per hr): At least 15 changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours continuous light (06:00 to 18:00) and 12 hours darkness.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eyes in the exposured animals were used as controls.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml, weighed approximately 91 mg.


Duration of treatment / exposure:
Up to 72 hours.
Observation period (in vivo):
Up to 72 hours.
Number of animals or in vitro replicates:
3 (one for the assessment of the initial pain reaction, two for the assessment of ocular damage/irritation).
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing : No.

SCORING SYSTEM:
Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment, according to the grading in the test guideline. The result was classified according to EU classification system.

TOOL USED TO ASSESS SCORE: The light source from a standard ophthalmoscope.

OTHERS
Immediately before the start of the test, both eyes of the provisionally selected test rabbits were examined for evidence of ocular irritation or defect with the aid of a light source from a standard ophthalmoscope. Only animals free of ocular damage were used. Initially, a single rabbit was treated. Immediately after administration of the test material, an assessment of the initial pain reaction was made according to the six point scale shown in Table 1 in 'any other information on materials and methods incl. tables'. After consideration of the ocular responses produced in the first animal, two additional animals were treated. In order to minimise pain on application of the test material, one drop of local anaesthetic (Tetracaine hydrochloride 0.5%, Chauvin Pharmaceuticals, Romford, Essex, United Kingdom) was instilled into both eyes of these animals 1 to 2 minutes before the treatment.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Remarks:
66659 Male
Time point:
other: mean of 24, 48 and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48-h
Remarks on result:
other: max score of 1 observed at 1-h and 24-h.
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #2
Remarks:
66707 Male
Time point:
other: mean of 24, 48 and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48-h
Remarks on result:
other: max score of 1 observed at 1-h and 24-h.
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #3
Remarks:
66715 Male
Time point:
other: mean of 24, 48 and 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48-h
Remarks on result:
other: max score of 1 observed at 1-h and 24-h.
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
66659 Male
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: max score of 1 was observed at 1-h, fully reversible within 24-h.
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
66707 Male
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: max score of 1 was observed at 1-h, fully reversible within 24-h.
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
66715 Male
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Remarks on result:
other: max score of 1 was observed at 1-h, fully reversible within 24-h.
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
66659 Male
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
66707 Male
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
66715 Male
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
66659 Male
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
66707 Male
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
66715 Male
Time point:
other: mean of 24, 48 and 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritant / corrosive response data:
Minimal conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24 hour observation. However, changes were fully reversible within 2 days. No corneal or iridal effects were noted. See Table 2 for the details.
Other effects:
Not reported.

Any other information on results incl. tables

Table 2 Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number and Sex 66659 Male 66707 Male 66715 Male
IPR = 3 IPR = 0 + IPR = 0 +
Time After Treatment 1 Hour 24 Hours 48 Hours 72 Hours 1 Hour 24 Hours 48 Hours 72 Hours 1 Hour 24 Hours 48 Hours 72 Hours
CORNEA                        
Degree of Opacity 0 0 0 0 0 0 0 0 0 0 0 0
Area of Cornea Involved 0 0 0 0 0 0 0 0 0 0 0 0
IRIS 0 0 0 0 0 0 0 0 0 0 0 0
CONJUNCTIVA                        
Redness 1 1 0 0 1 1 0 0 1 1 0 0
Chemosis 1 0 0 0  1 0 0 0 1 0 0 0
Discharge 0 0 0 0  1 0 0 0 1 0 0 0

IPR= Initial pain reaction     

Applicant's summary and conclusion

Interpretation of results:
other: not classified
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).
Executive summary:

Introduction. The study was performed to assess the irritancy potential of the test material following a single application to the eye of the New Zealand White rabbit. The method was designed to meet the requirements of the following:

OECD Guidelines for the Testing of Chemicals No. 405 “Acute Eye Irritation/Corrosion” (adopted 24 April 2002)

Commission Directive 92/69/EEC Method B5 Acute Toxicity (Eye Irritation) of Commission Directive 2004/73/EC

 

Initial considerations. In the absence of skin irritation data, a REET was performed prior to the in vivo test (see a brief summary in 'any other information on materials and methods incl. tables'). The results of the REET indicated that the test material was unlikely to cause severe occular irritancy.

Result. A single application of the test material to the non-irrigated eye of three rabbits produced minimal conjunctival irritation. All treated eyes appeared normal at the 48-hour aboservation.

 

Conclusion. The test material does not meet the criteria for classification according to EU classification system (Council Directive 67/548/EEC and Regulation (EC) No 1272/2008).