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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
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other: GLP-compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.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:
2010

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
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
liquid
Details on test material:
Sponsor's identification: Tripropylene glycol
Description: clear colourless slightly viscous liquid
Batch number: S-122009-310104
Purity: 99.6%
Expiry date: 14 June 2010
Storage conditions: at room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Harlan Laboratories U.K. Ltd, Hillcrest, Belton, Loughborough, UK.
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2.16 - 2.34 kg
- Housing: individually in suspended cages
- Diet: 2030 Teklad Global Rabbit diet supplied by Harlan Teklad, Blackthorn, Bicester, Oxon, UK ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23 °C
- Humidity (%): 30-70
- Air changes (per hr): at least 15 changes per hour
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1 ml
Duration of treatment / exposure:
Once, eye closed for 1 second
Observation period (in vivo):
1hour, 24, 48 and 72 hours following treatment
Number of animals or in vitro replicates:
2
Details on study design:
SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24 + 48 + 72 hr
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24 + 48 + 72 hr
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 + 48 + 72 hr
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 24 hr
Remarks on result:
other: slight redness (score 1) was observed in both animals 1 hr post-instillation
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24 + 48 + 72 hr
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 24 hr
Remarks on result:
other: slight chemosis (score 1) was observed in both animals 1 hr post-instillation
Irritant / corrosive response data:
No corneal or iridial effects were noted during the study.
Moderate conjunctival irritation was noted in both treated eyes one hour after treatment.
Both treated eyes appeared normal at the 24-Hour observation.
Initial pain response upon substance instillation into the eye of the first animal was 3 by 6-point scale. Therefore one drop of local anaesthetic (Tetracaine hydrochloride 0.5%, Chauvin Pharmaceuticals, Romford, Essex, UK) was instilled into both eyes of the second animal 1 to 2 minutes before treatment.
Other effects:
Both animals showed expected gain in bodyweight during the study.

Any other information on results incl. tables

Table 1               Individual Scores and Individual Total Scores for Ocular Irritation

Rabbit Number and Sex

69070 Male

69079 Male

IPR=3

IPR=0+

Time After Treatment

1

Hour

24

Hours

48

Hours

72

Hours

1

Hour

24

Hours

48

Hours

72

Hours

CORNEA

E = Degree of Opacity

F = Area of Cornea Involved

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Score(ExF)x5

0

0

0

0

0

0

0

0

IRIS

D

0

0

0

0

0

0

0

0

Score (D x 5)

0

0

0

0

0

0

0

0

CONJUNCTIVAE

A= Redness

B= Chemosis

C=Discharge

1

1

2

0

0

0

0

0

0

0

0

0

1

1

2

0

0

0

0

0

0

0

0

0

Score (A + B + C) x 2

8

0

0

0

8

0

0

0

Total Score

8

0

0

0

8

0

0

0

IPR = Initial pain reaction

+ = One drop of local anaesthetic instilled into both eyes 1 to 2 minutes before treatment

Applicant's summary and conclusion