Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation, other
Remarks:
Study in animals performed before Annex VII and VIII amendments.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
18 Apr 2005 - 16 May 2005
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study (OECD 405)

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
Eyes were rinsed after treatment
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): γ-Butyrolacton
- Analytical purity: 99.79%
- Purity test date: 21 Feb 2005
- Lot/batch No.: Behaelter B62
- Other: pH: ca. 5

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Lago S.A., France
- Age at study initiation: ca. 3 month
- Weight at study initiation: 2.41 kg
- Housing: single
- Diet: KLIBA Labordiaet (Kaninchen & Meerschweinchenhaltung), Provimi Kliba SA, Kaiseraugst, Switzerland, ad libitum
- Water: Tap water ad libitum
- Acclimation period: At least 5 days before the beginning of the study.


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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
Amount applied: 0.1 ml (undiluted)
Duration of treatment / exposure:
single application
Observation period (in vivo):
28 days
Number of animals or in vitro replicates:
1
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): The treated eye was rinsed with 3 to 6 mL of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: 24 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.3
Max. score:
4
Reversibility:
not fully reversible within: 28 days
Remarks on result:
probability of severe irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Max. score:
4
Reversibility:
fully reversible within: 14 days
Remarks on result:
no indication of irritation

Any other information on results incl. tables

Findings animal #1:

Time Opacity Iritis Conjunctival Erythema Conjunctival Chemosis
1 h - - 2 4
24 h 1 1 2 3
48 h 1 1 2 2
72 h 2 1 2 2
8 d 2 2 2 2
14 d 1 0 0 0
21 d 1 0 0 0
28 d 1 0 0 0
 Mean: 24h - 48h - 72h  1.3 1 2 2.3

Slight or moderate corneal opacity, moderate to severe iritis, moderate conjunctival redness, moderate to severe conjunctival chemosis and slight to severe discharge were observed in the animal during the course of the study. Additional findings like discharge of blood, contracted pupil, white discolored parts of the conjunctiva and nictitating membrane, marginal vascularization of the cornea as well as vascularization into the central part of the cornea, both in a circumscribed area, and injected scleral vessels in a circumscribed area or circular were noted in the animal during the observation period. The ocular reactions were not reversible in the animal within 28 days after application.

Applicant's summary and conclusion

Interpretation of results:
other: Non-corrosive but causes irreversible eye effects according to criteria in Regulation (EC) No 1272/2008
Remarks:
Criteria used for interpretation of results: EU