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:
01/12/2012-15/01/2013
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Conducted at a GLP accredited laboratory to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Brown liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source:Millbrook
- Age at study initiation: 28 weeks
- Weight at study initiation: 3.8-4.2kg
- Housing:Animals were individually housed in compliance with USDA Guidelines. The room in which the animals were kept was documented in the study records. No other species were kept in the same room.
- Diet (e.g. ad libitum): All animals had access to PMI Certified Hi-Fiber Rabbit Diet #5325.
- Water (e.g. ad libitum): the tap water was available as libitim to each ainmal via an automatic watering device.
- Acclimation period: A min 7 days prior to dosing their housing were acclimated.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 21 °C
- Humidity (%): 38-64
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):

IN-LIFE DATES: From: To:

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: other eyes were used as control
Amount / concentration applied:
0.1 mL
Duration of treatment / exposure:
Once
Observation period (in vivo):
6 days
Number of animals or in vitro replicates:
3
Details on study design:
Prior to dosing, the eyes were anesthetized using 2 drops of Tetracaine. Eltesol SDIBP 35/B was initially installed into the right eye of one male rabbit. The left eye was untreated. Following to one hour scores of the first animal, two additional animals were dosed. Scoring was done according to method of Draize.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 2 and 3
Time point:
other: 1 and 24h
Score:
0 - <= 1
Max. score:
3
Reversibility:
fully reversible within: 48h
Remarks on result:
other: mild opacity
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: one hour post dose
Score:
0 - < 1
Max. score:
1
Reversibility:
fully reversible within: 24h
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 1 hour post dose
Score:
> 1 - <= 2
Max. score:
2
Reversibility:
not fully reversible within: 6 days
Remarks on result:
other: conjunctival redness
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h dose dose
Score:
> 1 - < 4
Max. score:
4
Reversibility:
fully reversible within: 72 h
Irritant / corrosive response data:
No corneal, iris or conjunctival irritation was observed in the untreated eyes of the rabbits at any time point. Corneal irritation (mild opacity, scores of 1, involving app one quarter to less than three quaters of the corneas, scores of 1-3) was observed in the treated eyes of animals 1952 and 1953 at 1 h and 24hs post dose but resolved by 48hs post dose.
Moderate iritis (score of 1) was observed in animal 1952 at 1 h post dose with resolution by 24hs post dose.
Conjunctival redness (scores of 1) were observed beginning at 1h post dose, with a score of 2 for conjunctival redness for animal 1953 being observed at 24hs post dose. Scores of 1-2 for conjunctival redness persisted until day6.
Chemosis (scores of 1-4) were observed begining at 1h post dose with full resolution by 72hs. Scores of 2-3 for discharge were observed at 1h. Discharge resolved by 48h in 2 of 3 animals with irritation resolving in the remaining animal by 72h post dose. All 3 animals were observed to be normal on day 6 and the study was terminated.
Other effects:
No mortality was observed in the animals during to study. From one h post dose until completion of in-life, animals 1952 and 1953 appeared normal thoughout the study.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
Eltesol SDIBP 35/B was found to be non-irritating to the eyes according to EEC criteria. Eltesol SDIBP 35/B was found to be mildly irritating (cat 2B) to the eyes according to GHS criteria.
Executive summary:

SDIBP needs to be classified with Xi, R36 and Eye Damage 2, H319 according to classification criteria of Directive 67/548/EEC and Regulation (EC) No 1272/2008, respectively.