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:
other: 1a guideline study. Study was conducted in accordance to GLP and OECD guideline 405.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test substance: Propoxylated glycerol mw 300, pure colourless viscous liquid.
Purity: 99.98%, Contains 200 ppm antioxidant.
Batch No: 0133759A

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Daivid Percival Ltd, Moston, Cheshire, UK
- Age at study initiation: 12-16 weeks
- Weight at study initiation: 2.10 - 2.48

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The untreated eye served as a control.
Amount / concentration applied:
Undiluted
Amount applied: 0.1 ml
Vehicle: None
Duration of treatment / exposure:
Unspecified
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
Comment: not rinsed
REMOVAL OF TEST SUBSTANCE: Not Rinsed
SCORING SYSTEM: Draize
TOOL USED TO ASSESS SCORE: Standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: 24+48+72
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: 24, 48, 72 hr
Score:
0
Max. score:
4
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: 24, 48, 72 hr
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: 24, 48, 72 hr
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: 24, 48, 72 hr
Score:
0
Max. score:
2
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: 24, 48, 72 hr
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 hr
Score:
0
Max. score:
3
Remarks on result:
other: Redness grade 2 after 1 hr reversed after 24 hr.
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: 24, 48, 72 hr
Score:
0
Max. score:
3
Remarks on result:
other: Redness grade 2 after 1 hr reversed after 24 hr.
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 hr
Score:
0
Max. score:
3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hr
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: 24, 48, 72 hr
Score:
0
Max. score:
4
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: 24, 48, 72 hr
Score:
0
Max. score:
4
Irritant / corrosive response data:
Conjuctival redness (grade 2) was observed in the eye of 2 rabbits at 1 hour post-instillation. All observed signs of irritation fully reversed within 24 hours.
Other effects:
Residual test material was observed around the treated eye of all rabbits 1 hour after treatment.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Propoxylated glycerol mw 300 was not an eye irritant according to EC criteria.