Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6 October 1998 to 13 November 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted in compliance with OECD Guideline 405 and EU Method B.5

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1998
Report Date:
1998

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)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River Deutschland GmbH, Kißlegg, Germany
- Weight at study initiation: 3.51-3.91 kg
- Housing: separate cages arranged in a battery in fully air-conditioned rooms
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 1 week under study conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 50 ± 20 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Duration of treatment / exposure:
One administration (for times of removal of the test substance see below)
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
- Application of the substance to the conjunctival sac of the left eye of each animal

REMOVAL OF TEST SUBSTANCE
- Washing: Washing with isotonic saline at approx. 37 °C 24 h after administration and at all other designated examination times at which the treated eyes still showed discharge or at which a corneal examination with fluorescein sodium solution (24 and 72 h after administration) took place
- Time after start of exposure: see above

TOOL USED TO ASSESS SCORE: fluorescein-sodium, under UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not relevant since no effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not relevant since no effects
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 48 hours

Any other information on results incl. tables

Animal no. -- observation time -- cornea opacity -- cornea area -- iris -- conjunctiva redness -- conjunctiva chemosis -- conjunctiva discharge

311 -- 1 hour -- 0 -- 0 -- 0 -- 2 -- 1 -- 1

311 -- 24 hours -- 0 -- 0 -- 0 -- 1 -- 0 -- 0

311 -- 48 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0

311 -- 72 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0

314 -- 1 hour -- 0 -- 0 -- 0 -- 1 -- 0 -- 0

314 -- 24 hours -- 0 -- 0 -- 0 -- 1 -- 0 -- 0

314 -- 48 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0

314 -- 72 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0

315 -- 1 hour -- 0 -- 0 -- 0 -- 1 -- 0 -- 0

315 -- 24 hours -- 0 -- 0 -- 0 -- 1 -- 0 -- 0

315 -- 48 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0

315 -- 72 hours -- 0 -- 0 -- 0 -- 0 -- 0 -- 0

Mean individual scores after 24, 48 and 72 hours for animal no. -- corneal opacity -- iris -- conjunctivae redness -- conjunctivae chemosis

311 -- 0.0 -- 0.0 -- 0.3 -- 0.0

314 -- 0.0 -- 0.0 -- 0.3 -- 0.0

315 -- 0.0 -- 0.0 -- 0.3 -- 0.0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
According to the classification criteria of Regulation (EC) No 1272/2008 the test material is not irritating to eyes under these test conditions. The test material contains relevant amounts of the submission substance. Therefore the test results are considered adequate to fulfil the endpoint requirements.
Executive summary:

A study according to OECD Guideline 405 and EU Method B.5 was performed to investigate the irritation potential to the rabbit eye.

One and 24 hours after treatment the conjunctivae of the animals showed definitely injected blood vessels up to a diffuse crimson red colour. Additionally, a very slight swelling and slight from substance coloured eye discharge were observed in one animal one hour after treatment. Fourty-eight hours after treatment all signs of irritation were reversible.

As the mean values of the observed eye responses fall below the critical values for classification according to the criteria of Regulation (EC) No 1272/2008, the test material is not irritating to eyes and has not to be classified for eye irritation.