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Diss Factsheets

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: According to GLP, OECD-gudeline 405; 2004/73/EC, B.5.; US EPA OPPTS 870.2400; Japan/MAFF.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report date:
2009

Materials and methods

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

Test material

Constituent 1
Reference substance name:
Reaction mass of N-butylphosphorothioic triamide and N-propylphosphorothioic triamide
EC Number:
700-457-2
Molecular formula:
Unspecified
IUPAC Name:
Reaction mass of N-butylphosphorothioic triamide and N-propylphosphorothioic triamide
Details on test material:
- Name of test material (as cited in study report): LIMUS-Sambaydestillation
- Test-substance No.: 07/0684-1
- Physical state: solid/yellowish
- Analytical purity: 87%
- Lot/batch No.: 8712 / 062
- Storage condition of test material: < -18°C
- pH-value: ca. 9 (undiluted test substance)
- Stability: stable over 5 days

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S. A., 01540 Vonnas, France
- Age at study initiation:
- Weight at study initiation: 2.80 kg – 3.19 kg
- Housing: single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2.
- Diet (e.g. ad libitum): Kliba-Labordiät (Kaninchen & Meerschweinchenhaltung “GLP”), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/a nimal per day)
- Water (e.g. ad libitum): tap water
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL bulk volume (about 74 mg of the comminuted test substance).
- Concentration (if solution): undiluted

Duration of treatment / exposure:
24 h
Observation period (in vivo):
21 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): with 3 to 6 mL of warm water for approx. 1 to 2 minutes
- Time after start of exposure: 24 h

SCORING SYSTEM: according to OECD-guideline

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: individual scores: 1 - 1 - 1
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: individual scores: 1 - 1 - 0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
other: individual scores: 1 - 2 - 2
Irritation parameter:
iris score
Basis:
other: animals # 1 and 2
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: individual scores: 1 - 0 - 0
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: individual scores: 1 - 1 - 1
Irritation parameter:
conjunctivae score
Basis:
other: animals # 1, 2, 3
Time point:
other: 24 - 48 - 72 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: individual scores: 2 - 2 - 2
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24 - 48 - 72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: individual scores: 2 - 2 - 2
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24 - 48 - 72 h
Score:
1.7
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: individual scores: 2 - 2 - 1
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24 - 48 - 72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 21 days
Remarks on result:
other: individual scores: 3 - 2 - 2
Irritant / corrosive response data:
The average score (24 to 72 hours; animal # 1, 2 and 3) for irritation was calculated to be 1.1 for corneal opacity, 0.6 for iris, 2.0 for conjunctivae redness and 2.0 for chemosis. Since the findings were not reversible in all animals within 72 hours, the study was further conducted till day 21 after application. All findings were fully reversible within this time.

Any other information on results incl. tables

Additional findings like suppuration, contracted pupil, discharge of blood, vascularization into the central part of the cornea in a circumscribed area and injected scleral vessels in a circumscribed area or circular were noted in the animals during the observation period.

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information
Conclusions:
Considering the described ocular reactions as well as the average score for irritation, LIMUS-Sambaydestillation shows an eye irritation potential. Under the conditions of the test, the substance has to be classified R 36 (Directive 67/548/EEC) and Eye corrosion/irritation Cat 2A (GSH (UN)).