Registration Dossier

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:
other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

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 (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): monoethanolamine oleate
- Physical state: light brown, highly viscous/pasty liquid
- Analytical purity: 99.8%
- Lot/batch No.: SEALS 104/1
- Expiration date of the lot/batch: 1 September 2012
- Stability under test conditions:
- Storage condition of test material:

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Centre Lago
- Body weight at study initiation: 4468, 4625 and 4132 g
- Age at study initiation: adult
- Housing: individually in cages (Technilab), fitted with a perforated floor (610 x 610 x 450 mm) with a closed bottom polypropylene box (60 x 40 12 cm) with Lignocel 3/4 as bedding placed on the perforated floor. A wooden block was given as cage enrichment.
- Diet: standard laboratory diet (SDS Special Diets sercives, Whitham, England)
- Water: tap water (N.V. Vitens), ad libitum
- Acclimation period: at least 5 days (animals were reserve animals of other TNO Triskelion studies)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 ± 3
- Humidity (%): 45-70
- Air changes (per hr): ca. 10/hour
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye served as a concurrent control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.1 mL
Duration of treatment / exposure:
Single instillation
Observation period (in vivo):
1, 24, 48, 72 hours and 7 days
Number of animals or in vitro replicates:
3 males
Details on study design:
SCORING SYSTEM: Draize

The study was carried out because the non-GLP evaluation of eye irritaion in vitro using the Isolated Chicken Eye Test (OECD 438) did not reveal signs of severe irritance. The study was carried out using a sequential procedure, i.e. starting with one rabbit and after the 1 hour observation (depending on the severity of the eyeeffects) the next two rabbits.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 + 48 + 72 hours
Score:
0.87
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Individual scores: 0.3, 1.0, 1.3
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 + 48 + 72 hours
Score:
0.77
Max. score:
2
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Individual scores: 0.3, 1.0, 1.0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 + 48 + 72 hours
Score:
1.77
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Individual scores: 1.3, 2.0, 2.0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 + 48 + 72 hours
Score:
1.43
Max. score:
4
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Individual scores: 0.3, 2.0, 2.0
Irritation parameter:
other: ocular discharge
Basis:
mean
Time point:
other: 24 + 48 + 72 hours
Score:
1.78
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Individual scores: 0.67, 1.67, 1.67
Irritant / corrosive response data:
At 1 hour after treatment, slight corneal opacity (2 rabbits), slight iritis, slight redness and slight swelling of the conjunctivae and moderate ocular discharge were observed in the three rabbits. At 24 hours after treatment, slight or moderate corneal opacity, slight iritis, moderate redness and slight or moderate swelling of the conjunctivae and moderate ocular discharge were observed in the three rabbits. At 48 and 72 hours after treatment, two rabbits showed slight corneal opacity, slight iritis, moderate redness and moderate swelling of the conjunctivae and slight or moderate ocular discharge, while the third rabbit only showed slight redness of the conjunctivae. At 7 days after treatment, all eye effects had cleared completely.

Applicant's summary and conclusion