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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:
weight of evidence
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2002

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Propylidenetrimethanol, propoxylated mw 310; clear,
colourless, viscous liquid; purity not reported

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: David Percival Ltd, Moston, Cheshire, UK.
- Age at study initiation: 12 - 20 weeks
- Weight at study initiation: 2000 - 3500 g
- Housing: Suspended metal cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days


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


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left was used for control purposes
Amount / concentration applied:
Amount applied: 0.1 ml
Observation period (in vivo):
after 1, 24, 48 and 72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
Not rinsed


SCORING SYSTEM: Draize Scoring System


TOOL USED TO ASSESS SCORE: Standard opthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 hrs
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 hrs
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 hrs
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 hrs
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 hrs
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 24 hrs
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 hrs
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 hrs
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 hrs
Score:
1.7
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean 24, 48, 72 hrs
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean 24, 48, 72 hrs
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean 24, 48, 72 hrs
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 hrs
Irritant / corrosive response data:
Dulling of the normal lustre of the cornea was noted in one treated eye one hour after treatment. Scattered or diffuse areas of corneal opacity were noted in two treated eyes 24 hours after treatment. Iridial inflammation was noted in all treated eyes 1 and 24 hours after treatment. Moderate conjunctival irritation was noted in all treated eyes 1, 24 and 48 hours after treatment with minimal conjunctival irritation noted 72 hours after treatment.

Any other information on results incl. tables

AVERAGE SCORE (24,48,72 hours) per animal 1 / 2 / 3
- Cornea: 0.0 / 0.3 / 0.3
- Iris: 0.3 / 0.3 / 0.3
- Conjuntivae (Redness): 1.7 / 1.7 / 1.7
- Conjuntivae (Chemosis): 0.7 / 1.0 / 1.0

All treated eyes appeared normal after 7 days.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test material produced a maximum group mean score of 24.3 and was classified as a MODERATE IRRITANT (CLASS 5 ON A 1 TO 8 SCALE) to the rabbit eye according to a modified Kay and Calandra classification system. The test material did not meet the criteria for classification as irritant according to the CLP Regulation.
Executive summary:

The eye irritation potential of propylidenetrimethanol, propoxylated was investigated in a rabbit study (OECD 405). 0.1 mL was instilled into one eye of three rabbits and ocular reactions were assessed for up to 72 hours. Dulling of the normal lustre of the cornea was noted in one treated eye one hour after treatment. Scattered or diffuse areas of corneal opacity were noted in two treated eyes 24 hours after treatment. Iridial inflammation was noted in all treated eyes 1 and 24 hours after treatment. Moderate conjunctival irritation was noted in all treated eyes 1, 24 and 48 hours after treatment with minimal conjunctival irritation noted 72 hours after treatment.