Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18.05.2000 to 25.05.2000
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report Date:
2000

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Dequest 2004A
- Substance type: phosphonic acid (potassium salt)
- Physical state: Clear slightly yellow liquid
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Purity test date: No data
- Lot/batch No.: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: Room temperature

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Myrtle's Rabbitry, Thompson Station, TN.
- Age at study initiation: 'adult'
- Weight at study initiation: 2.672 to 2.890 kg
- Housing: Individually in suspended stainless steel cages
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: Minimum five days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-19
- Humidity (%): 47-69
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 18.05.2000 To: 25.05.2000

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
Rinsing after 24 hours
Observation period (in vivo):
Seven days
Number of animals or in vitro replicates:
Six
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours


SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: hand-slit lamp and fluorescein. The eyes were macroscopically examined with the aid of an auxiliary light source for signs of irritation at 1, 24, 48 and 72 hours and up to 7 days after dosing. Following macroscopic observations at the 24 hour scoring interval, the fluorescein examination procedure was repeated on all test and control eyes and any residual test article was gently rinsed from the eye at this time using saline. If any fluorescein findings were noted at 24 hours, a fluorescein examination was conducted on the affected eyes at each subsequent interval until a negative response was obtained and/or until all corneal opacity had cleared.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.17
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.06
Max. score:
2
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Corneal opacity in 3/6 animals at the one hour scoring interval. Corneal injury was confirmed by positive fluorescein dye retention in 1/3 eyes at 24 ours. All corneal opacities had resolved by seven days. Iritis was observed in 3/6 animals at the one hour interval, which had resolved by 48 hours. Conjunctivitis was noted in all six animals after one hour. This conjunctivitis had reversed by seven days. There were no signs of irritation in the control eyes.
Other effects:
None reported.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
In an eye irritation study (reliability score 1) conducted to OECD 405 and GLP, potassium salt of ATMP caused minimal initial irritation to the eyes of rabbits.
Executive summary:

In an eye irritation study (reliability score 1) conducted to OECD 405 and GLP, potassium salt of ATMP caused minimal initial irritation to the eyes of rabbits.