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Diss Factsheets

Toxicological information

Eye irritation

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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 and appropriate guidelines
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

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:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to guideline
Guideline:
other: Japanese Ministry of Agriculture, Forestry and Fisheries, Test Data for Registration of Agricultural Chemicals, Eye Irritation (2-1-5), 12 Nohsan No. 8147, Agricultural Production Bureau, November 24, 2000.
Deviations:
no
Principles of method if other than guideline:
n/a
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Diethyl (hydroxymethyl)phosphonate
EC Number:
221-391-6
EC Name:
Diethyl (hydroxymethyl)phosphonate
Cas Number:
3084-40-0
Molecular formula:
C5H13O4P
IUPAC Name:
diethyl (hydroxymethyl)phosphonate
Constituent 2
Reference substance name:
Diethoxyphosphoryl methanol
IUPAC Name:
Diethoxyphosphoryl methanol
Test material form:
other: liquid
Details on test material:
E06-16 (Lot No. 1041-37-6, T# 184), a colotless liquid. Stored in dark at room temp. (Approximately 25oC).
The test material was stable for the duration of the study.

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Animals for this study were selected from a stock supply of healthy adult rabbits.
Number of animals - 3 male rabbits
Age of start of treatment- 35 to 42 weeks
Bodyweight range of 3.01 to 3.50 kg
Identification- A numbered tag placed through the edge of one ear.
Husbandary: Daily average animal room temperature and relative humidity within the range 16 to 20°C, and 40 to 70%. respectively.
Light: 12 hr artificial light 12 hr dark.
Accommodation: Individually in labelled cages. Each cage was identified by a coloured label displaying the study number and animal number.
All rabbits were acclimatised to the experimental environment for a period of approximately 15 weeks prior to the start of the study.
Diet and water: Each animal was housed individually in a plastic cage with perforated floors and was offered
150 g of a standard laboratory rabbit diet per day; drinking water was provided ad libitum.
The batch of diet used for the study is analysed for nutrients, possible contaminants and
micro-organisms likely to be present in the diet and which, if in excess of specified amounts,
might have an undesirable effect on the test system. A dietary supplement of hay was offered
during acclimatisation until two days prior to dose instillation; for the remainder of
acclimatisation and throughout the study observation period wholemeal bread was offered.
Twice weekly a supplement of fresh chopped vegetables was given.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 mL of the test substance
Duration of treatment / exposure:
24h
Observation period (in vivo):
0, 1, 24, 48 and 72 hours after test material administration.
All rabbits were observed at least once each day for mortality and moribundity.
Number of animals or in vitro replicates:
3 treated animals.
Details on study design:
The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage, iridial inflammation or conjunctival irritation. Each animal was gently restrained. The dose (0.1 mL) was instilled into the right eye by pulling the lower eyelid away from the eye ball to form a cup into which the test substance was dropped. The left eye remained untreated and served as a control. The eyelids were then gently held together for one second before releasing. The treated and control eyes of each test rabbit were examing using a penlight. The cornea was observed for presence and/or degree of opacity; the iris for deepened rugae, congestion, swelling and circumcorneal injection, and reaction to light; and the conjunctiva for redness and chemosis.
Evaluation of the results: For each animal, mean scores for corneal opacity, iris lesions, conjunctival redness and chemosis were calculated by addingthe scores at 24, 48 and 72 hours and dividing by three. The irritation potential of the test material was assessed according to the system of Kay and Calandra, 1962.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1h
Score:
1.7
Max. score:
1.7
Reversibility:
fully reversible within: 24h
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1h
Score:
6
Max. score:
6
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
24 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24 h
Score:
1.3
Max. score:
1.3
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
48 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
48 h
Score:
0.7
Max. score:
0.7
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Injection of the conjunctival blood vessels or a crimson-red conjunctival appearance was
apparent in all animals one hour after instillation persisting in one animal for twenty-four
hours and in another for forty-eight hours. Very-slight or slight discharge was evident in all
animals one hour after instillation and iritis was apparent in one case at this time. The treated
eyes of all animals were overtly normal 72 hours after instillation.
Instillation of the test material gave rise to no initial pain response.
Other effects:
There was no sign of toxicity or ill health in any rabbit during the observation period.

Any other information on results incl. tables

n/a

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Conclusions:
The test material is judged to be minimally irritating.
Executive summary:

Three rabbits were each administered a single ocular dose of a volume of 0.1 mL of the test substance and observed for four days after instillation.

Injection of the conjunctival blood vessels or a crimson-red conjunctival appearance was apparent in all animals one hour after instillation persisting in one animal for twenty-four hours and in another for forty-eight hours. Very-slight or slight discharge was evident in all animals one hour after instillation and iritis was apparent in one case at this time. The treated eyes of all animals were overtly normal 72 hours after instillation.