Registration Dossier

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:
01 December 2011 - 22 December 2011
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted in compliance with EC, OECD, EPA, and Japanese test guidelines, and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
Qualifier:
according to
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
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): Ferrophosphorous (Fe3P)
- Physical state: Solid
- Analytical purity: Fe 83.39%; P 16.0%
- Lot/batch No.: 1192691
- Expiration date of the lot/batch: 31 December 2011
- Stability under test conditions: Stable
- 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
- Age at study initiation: 44 to 47 weeks
- Weight at study initiation: 3.98 to 4.52 kg
- Housing: Housed individually in plastic cages with perforated floors
- Diet (e.g. ad libitum): Ad libitum access to standard laboratory diet.
- Water (e.g. ad libitum): Ad libitum access to drinking water.
- Acclimation period: At least 25 weeks.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 20°C
- Humidity (%): 40 - 70%
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark.

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: No dedicated control animals were used; in each animal the right eye was treated; the left eye remained untreated.
Amount / concentration applied:
100 mg
Duration of treatment / exposure:
Not applicable. A single intillation of the test material was made; eyelids were held together for one second before releasing.
Observation period (in vivo):
72 hours; observations were made 1, 24, 48, and 72 hours after treatment.
Number of animals or in vitro replicates:
Three females
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): None

SCORING SYSTEM: Consistent with the system described in the EU test method (Commision regulation 440/2008, Part B, method B5).

TOOL USED TO ASSESS SCORE: An opthalmoscope or pencil beam torch was available.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 hour
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 24 hours
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1 hour
Score:
0
Max. score:
3
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
3
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 - 72 hours
Score:
0
Max. score:
3
Irritant / corrosive response data:
Injection of the conjunctival blood vessels was apparent in one animal one hour after instillation; no reaction to treatment was evident in the other animals. The treated eyes of all animals were overtly normal 24 hours after instillation

Instillation of the test substance gave rise to practically no initial pain response.
Other effects:
There was no sign of toxicity or ill health in any rabbit during the observation period.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The highest total mean score was 2.0 occurring at the one hour observation; accordingly under the criteria Kay and Calandra (1962) Ferrophosphorus (Fe3P) was classified as “practically non-irritating” to the eye. Ferrophosphorus (Fe3P) did not require labelling in accordance with European Commission regulation 1272/2008.