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
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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Remarks:
The Department of Health of the Government of the United Kingdom, GLP Monitoring Authority, UK

Test material

Constituent 1
Chemical structure
Reference substance name:
Propylidynetrimethanol, propoxylated
EC Number:
500-041-9
EC Name:
Propylidynetrimethanol, propoxylated
Cas Number:
25723-16-4
Molecular formula:
C3H5(CH2OR)3 R= (C2H3(CH3)O)nH sum of n: >1 - <6.5 mol PO
IUPAC Name:
Propylidynetrimethanol, propoxylated
Details on test material:
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: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The left eye was used as control
Amount / concentration applied:
0.1 mL
Observation period (in vivo):
1, 24, 48 and 72 h
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:
24/48/72 h
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
4
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.3
Max. score:
2
Reversibility:
fully reversible within: 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1.7
Max. score:
3
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritant / corrosive response data:
Dulling of the normal lustre of the cornea was noted in one treated eye 1 h after treatment. Scattered or diffuse areas of corneal opacity were noted in two treated eyes 24 h after treatment. Iridial inflammation was noted in all treated eyes 1 and 24 h after treatment. Moderate conjunctival irritation was noted in all treated eyes 1, 24 and 48 h after treatment with minimal conjunctival irritation noted 72 h after treatment. Moderate to minimal swelling (chemosis) was found at the 1, 24 and 48 h reading in all animals.

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
- Conjunctivae (Redness): 1.7 / 1.7 / 1.7
- Conjunctivae (Chemosis): 0.7 / 1.0 / 1.0

All treated eyes appeared normal after 7 days.

Additional data supporting the information is attached below under 'Attached background material'.

Applicant's summary and conclusion

Interpretation of results:
other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008.
Conclusions:
Propylidentrimethanol, propoxylated resulted in only slight irritation of the skin of rabbit, which was fully reversible within 7 days.