Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
30 Aug 2010 to 9 Sep 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
minor deviations, not affecting the study results
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
minor deviations, not affecting the study results
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
yes
Remarks:
minor deviations, not affecting the study results
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): TTP
- Description: Clear colourless liquid (determined at NOTOX)
- Storage condition of test material: At room temperature in the dark under nitrogen
- Stability under storage conditions: Stable

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River France, L¿Arbresle Cedex, France
- Age at study initiation: 13 -16 weeks
- Weight at study initiation: 2,7 - 2,9 kg
- Housing: individually in cages
- Diet: Global Diet 2030 from Harlan Teklad®, Mucedola, Milanese, Italy, 100 g/day and hay (TecniLab-BMI BV, Someren, The Netherlands), at least 3-times a week
- Water (ad libitum): tap water
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 3
- Humidity (%): 40 - 70 (actual 42 - 88)
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: one eye treated, the other eye remained untreated and served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
Duration of treatment / exposure:
72 h
after 24 h a solution of 2% fluorescein (Merck, Darmstadt,
Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to
quantitatively determine corneal epithelial damage
Observation period (in vivo):
72 h, examinations 1, 24, 48 and 72 h after instillation
Number of animals or in vitro replicates:
3 males
Details on study design:
REMOVAL OF TEST SUBSTANCE
no

SCORING SYSTEM: according to guideline

TOOL USED TO ASSESS SCORE: fluorescein
after 24 h a solution of 2% fluorescein (Merck, Darmstadt,
Germany) in water (adjusted to pH 7.0) was instilled into both eyes of each animal to
quantitatively determine corneal epithelial damage

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: no effects observed
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.43
Max. score:
3
Reversibility:
fully reversible within: 72 h
Remarks on result:
other: values of individual animals: 0.7, 0.3, 0.3
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 72, 48 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: a score of 1 was observed in all animals 1 h after instillation
Irritant / corrosive response data:
The maximal conjunctivae redness score was 2 in one animal (1 h after instillation), declining to 1 (24 and 48 h) and fully reversible within 72 h
The two other animals revealed redness scores of 1 (1 and 24 h after instillation), fully reversible within 48 h
Other effects:
A discharge score of 1 (any amount different from normal and/or lacrimation) was oberved in all three animals 1 h after instillation, with full reversibility within 24 h

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this study the test item is considered to be not irritating to the eye
Executive summary:

Single samples of 0.1 mL of the undiluted test item were instilled into one eye of each of three male New Zealand white rabbits. The other eye served as internal control. Observations were made 1, 24, 48 and 72 hours after instillation. Instillation of the test substance resulted in a slight irritation of the conjunctivae, which consisted of redness (mean score 24 - 72 h: 0.43, maximal value: 2 after 1 h), chemosis (mean score 24 - 72 h: 0, maximal value: 1 after 1 h) and minimal discharge. The irritation completely resolved within 72 hours in one animal and within 48 hours in the other two animals.

Based on these results the test item does not have to be classified and has no obligatory labelling requirement for eye irritation according to the Regulation (EC) No 1272/2008.