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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
Study period:
November 23, 1988 - November 26, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Test was conducted according to OECD Test Guideline No. 405, 1987 and under GLP Standards and QA. Chemical identity and purity of the test substance are not reported.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
1987
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
1984
Deviations:
no
Principles of method if other than guideline:
Not applicable
GLP compliance:
yes
Remarks:
Statement of Compliance

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 3-[(diphenoxyphosphoryl)oxy]phenyl triphenyl 1,3-phenylene bis(phosphate) and tetraphenyl 1,3-phenylene bis(phosphate)
EC Number:
701-337-2
Cas Number:
not available
Molecular formula:
C30H24O8P2
IUPAC Name:
Reaction mass of 3-[(diphenoxyphosphoryl)oxy]phenyl triphenyl 1,3-phenylene bis(phosphate) and tetraphenyl 1,3-phenylene bis(phosphate)
Details on test material:
- Name of test material (as cited in study report): CR 733-S
- Physical state: Liquid
- Lot/batch No.: confidential
- Storage condition of test material: At ambient 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: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: Adult
- Weight at study initiation: 2624, 2830, 2894 gram
- Housing: Individually housed in a plastic cage with a perforated floor
- Diet: Standard laboratory animal diet (100 g per day, LKK-20, diameter 4 mm), obtained from Hope Farms, Woerden, The Netherlands
- Water: Tap-water (via automatic nozzles) ad libitum
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20
- Humidity (%): 35 - 50
- Air changes (per hr): Air conditioned
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: No data

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: right eye, untreated
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): undiluted
Duration of treatment / exposure:
72 hours (not rinsed)
Observation period (in vivo):
Immediately after and approx. 60 min., 24, 48 and 72 hours after instillation of the test substance
Number of animals or in vitro replicates:
3 females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): not rinsed

SCORING SYSTEM: 1) subjective numerical according to OECD Guideline 405 (corneal, iridic and conjunctival irritation (redness/chemosis)).
2) Approx. Draize score (J. Pharmacol. Exp. Ther. 82, 1944). This score was calculated with the following formula: (5 * corneal opacity grade * area of opacity grade) + (5 * iridial injury grade) + 2 * (conjunctival redness grade + chemosis grade + discharge grade).

TOOL USED TO ASSESS SCORE: fluorescein

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:
4
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
Instillation of 0.1 ml of the test substance in one of the eyes of each of three albino rabbits resulted in adverse effects to the conjunctivae only. Approximately 60 min after exposure, one rabbit showed slight conjunctival redness and slight chemosis, which resolved within 24 hours.
All three animals showed slight lacrimation on day 0.
No adverse effects to the cornea and the iris were observed in any of the animals during the entire observation period. Treatment of the eyes with fluorescein 24 hours after instillation of the test substance did not reveal any corneal epithelial damage.
Other effects:
No signs of systemic intoxication were observed in any of the rabbits.

Any other information on results incl. tables

Not relevant

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
According to the EU criteria for classification and labelling of dangerous substances, the test substance need not be labelled as an eye irritant.
Executive summary:

A sample of CR 733-S was tested in the rabbit acute eye irritation/corrosion test, performed according to OECD Guideline 405, 1987. Instillation of 0.1 ml of the test substance in one of the eyes of each of three albino rabbits resulted in adverse effects to the conjunctivae only. Approximately 60 min. after exposure, one animal showed slight reddening of the eyelids and slight chemosis, which resolved within 24 hours. No other adverse eye effects were observed in the treated animals, except for slight lacrimation on day 0.

Based on the estimated Draize score (1944) of 3.3 (60 min), the test substance should be classified as minimally irritating according to the scheme of Kay and Calandra (1962).

According to the criteria laid down in Annex VI of the EEC Council Directive 67/548/EEC (amended by Directive 83/467/EEC), and outlined in 1272/2008/EC (CLP/EU-GHS), the test substance need not be labelled as an eye irritant.