Registration Dossier

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
02 Jun 1986 - 06 Jun 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP - Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
analytical purity of test substance not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Pripol 1017
- Physical state: viscous liquid
- Analytical purity: no data
- Composition of test material, percentage of components: Mixture of fatty acids; C18-unsatd., dimers 79 %, trimer 19 %, monomer 2 %
- Storage condition of test material: at ambient temperature in the dark
- Other: yellow

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: The Broekman Institute
- Age at study initiation: 12-14 weeks
- Weight at study initiation: ~2.8 kg
- Housing: individually housed in plastic cages with perforated floors
- Diet: standard laboratory animal diet restricted to 100 g per day
- Water (ad libitum): tap water
- Acclimation period: 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.5 - 21.5
- Humidity (%): 60 - 70
- Photoperiod (hrs dark / hrs light): 12 / 12


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreated eye served as control
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
single instillation
Observation period (in vivo):
96 hours; reading time points: ~1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Grading of the ocular lesions (Cornea, Iris and Conjunctivae) according to Draize scoring system


TOOL USED TO ASSESS SCORE: fluorescein
24 hours after instillation of the test substance, a solution of 2 % fluorescein in water was applied to both eyes of each animal to quantitatively examine the potential for corneal injury.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal: #1, 2, 3
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1, 2, 3
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean over 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: effect occurred ~1 h after instillation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean over 24, 48, 72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: effect occurred ~1 h after instillation
Irritant / corrosive response data:
Slight conjunctival redness was observed in all animals, as well as slight chemosis in two of the rabbits. In all animals these conjunctival effects disappeared within 96 hours. A slight increase in lacrimation was observed on days 1 and 2. Adverse effects on the cornea and the iris were not observd on days 1 and 2. Adverse effects on the cornea and the iris were not observed in any of the rabbits during the entire observation period. Treatment of the eyes with fluorescein did not reveal any epithelial damage.
Other effects:
Signs of systemic intoxication were not observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance does not fulfil the requirements to be classified according to DSD and CLP criteria for classification and labelling.
DSD: no classification
CLP: no classification