Registration Dossier

Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-08-08 to 2000-08-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): ULTRAPURE propylene carbonate
- Physical state: clear liquid
- Analytical purity: 100%
- Lot/batch No.: 9L610
- Storage condition of test material: ambient temperature in the dark
- Stability under test conditions: responsibility of the Sponsor

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Charles River UK Limited, Margate, Kent, UK.
- Age at study initiation: young adults
- Weight at study initiation: 3553-4142 g
- Housing: individually, in cages suitable for animals of this strain and the weight range expected during the course of the study
- Diet (e.g. ad libitum): Diet (STANRAB SQC),ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: min.5d


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C±3°C
- Humidity (%): 30-70%
- Air changes (per hr): min of 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12h light ,12h dark

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL
Duration of treatment / exposure:
1-2sec.
Observation period (in vivo):
10 days
Number of animals or in vitro replicates:
3M
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data


SCORING SYSTEM:
Draize scale to assess the grade of ocular reaction
Kay and Calandra system


TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1h
Score:
0
Max. score:
80
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1d
Score:
8.3
Max. score:
80
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 2d
Score:
3.3
Max. score:
80
Reversibility:
fully reversible within: 3 days
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1h
Score:
0
Max. score:
10
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1d
Score:
1.7
Max. score:
10
Reversibility:
fully reversible within: 2 days
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 1h and 1d
Score:
13.3
Max. score:
20
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 2d
Score:
10
Max. score:
20
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 3d
Score:
4.7
Max. score:
20
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 4d
Score:
3.3
Max. score:
20
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7d
Score:
1
Max. score:
20
Reversibility:
fully reversible within: 10 days
Irritation parameter:
maximum mean total score (MMTS)
Basis:
mean
Time point:
other: day1
Score:
23.3
Max. score:
110
Irritation parameter:
other: Final irritation score
Basis:
mean
Time point:
other: 7d
Score:
5
Max. score:
8
Reversibility:
not specified
Remarks on result:
other: moderate irritant
Irritant / corrosive response data:
Observation:
-slight corneal opacity observed in 2/3 animals for up to 2 days
-slight iritis was seen in 1/3 animal for 1 day after instillation.
-conjunctival effects were seen in 3/3 animals for up to 7 days (slight or moderate redness, slight or mild chemosis and a moderate or severe discharge).
Other effects:
Observation: additional signs of irritation consisted of Harderian or mucoid discharge, erythematous or thickened eyelids, haemorrhage of the nictitating membrane and dried secretion around the periorbital skin were observed.

Applicant's summary and conclusion

Interpretation of results:
Category 2A (irritating to eyes)
Conclusions:
ULTRAPURE propylene carbonate is a moderate irritant (class 5 on a 1-8 scale) to the rabbit eye. According to the criteria laid down in the CLP Regulation (EC) 1272/2008, propylene carbonate is classified as an eye irritant substance category 2 (irritating to eyes) as the mean redness score is 2 at 24, 48 and 72 hours in 2 of the 3 animals tested and the effects are fully reversible within 10 days.