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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2005
Report Date:
2005

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Qualifier:
according to
Guideline:
other: MAFF Testing Guideline of 12 Nousan No. 8147
GLP compliance:
yes (incl. certificate)
Remarks:
Experimental Toxicology and Ecology, BASF Aktiengesellschaft, 67056 Ludwigshafen/Rhein, Germany

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: ≥ 92%- pH: ≥ 1 - ≤ 5 (aqueous preparation)
Specific details on test material used for the study:
- Name substance: PVP-Iod 30/06- Test substance No.: 04/0282-1- Batch-No: Lot: G2295BPZO- Date of production: 15 Oct 2002- Purity: 97.2 g/100g- Storage conditions: room temperature

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: about 5 months- Weight at study initiation: 3.54 – 3.66 kg- Housing: single housing in stainless steel wire mesh cages with grating, floor area: 3000 cm2- Diet: Kliba-Labordiät (Kaninchen & Meerschweinchen-haltung „GLP“), Provimi Kliba SA, Kaiseraugst, Basel, Switzerland (about 130 g/animal per day)- Water: tap water ad libitum- Acclimation period: at least 5 daysENVIRONMENTAL CONDITIONS- Temperature (°C): 20 - 24- Humidity (%):30 - 70- Air: fully air-conditioned- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 mL bulk volume (about 33 mg of the comminuted test substance) was applied to the conjunctival say of the right eyelid
Duration of treatment / exposure:
1 hour
Observation period (in vivo):
28 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE - Washing: the treated eye was rinsed with 3 to 6 mL of hand warm tap water for 1 tot 2 minutes using a syringe with a blunt probe - Time after start of exposure: 1 hour SCORING SYSTEM: Readings were performed approx. 1, 24, 48 and 72 h after application and then in weekly intervals maximally up to day 28. For evaluation, the calculation of the mean values of corneal opacity, iris, conjunctival redness and chemosis for readings 24, 48 and 72 hours were quoted. Additionally, the reversibility of the observed findings was taken into account . The evaluation is based on the criteria of Annex VI of the Commission Directive 67/548/EEC that were in place on the date of report TOOL USED TO ASSESS SCORE: daylight tubes “Lumilux” (L 58W/860 PLUS ECO 25x1, Osram, Germany)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
4
Reversibility:
not fully reversible within: 28 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
iris score
Basis:
animal: #2, #3
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 28 days
Irritation parameter:
chemosis score
Basis:
animal: #1, #3
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 21 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
Slight corneal opacity (grade 1) was observed in all animals 24 hours after application and persisted up to 48 or 72 hours in one animal each. In one of these animals slight corneal opacity was again noted on day 14 only. In the third animal slight corneal opacity increased to moderate (grade 2) at the 48-hour reading up to day 7 and increased to marked (grade 3) on day 14 up to day 28 (study termination). Moderate iritis (grade 1) was observed in all animals 24 hours after application and persisted in one animal up to 48 hours and in two animals until 72 hours. Moderate or severe conjunctival redness (grade 2 or 3) were noted in all animals from 1 hour up to 72 hours after application. Slight or moderate conjunctival redness (grade 1 or 2) were observed in all animals on day 7 and in two animals on day 14. Moderate conjunctival redness decreased to slight in one animal after 21 days. Moderate or marked conjunctival chemosis (grade 2 or 3), noted in all animals 1 hour after application up to 72 hours, decreased to slight (grade 1) in one animal on day 7. Slight conjunctival chemosis persisted in one animal up to day 14 Slight to severe discharge (grade 1 to 3) was noted in all animals 1 hour after application up to 48 hours and in two animals up to 72 hours. Additional findings like small retraction in the eyelid, suppuration, contracted pupil, discharge of blood, loss of corneal tissue, marginal vascularization of the cornea in a circumscribed area as well as vascularization into the central part of the cornea in a circumscribed area and injected scleral vessels in a circumscribed area or circular were noted during the observation period. In two animals the ocular reactions were reversible within 14 or 28 days after application. The ocular reactions were not reversible in one animal within 28 days after application. Marked corneal opacity (area involved > ¼ < ½ circular, in the central part of the eye), small retraction in the eyelid, contracted pupil, injected scleral vessels in a circumscribed area and vascularization into the central part of the cornea in a circumscribed area (about half of the eye) were still observed in this animal at study termination on day 28.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria