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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
Not known if conducted to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

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:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
- Name of test material (as cited in study report): Polyol TP30
Trimethylolpropane, ethoxylated, molar ratio 1 : 3
clear viscous liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Buckmasters, Henham, Hertfordshire, England
- Age at study initiation: 12 - 14 weeks
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum


Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: The contralateral eye remained untreated and served as a control
Amount / concentration applied:
Amount applied: 0.1 ml
Observation period (in vivo):
after 1 hour and 1, 2, 3, 4 and 7 days after instillation
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 - #3
Time point:
other: 1 hour, 1, 2, 3, 4 and 7 days
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
animal: #1 - #3
Time point:
other: 1 hour and 1, 2, 3, 4 and 7 days
Score:
0
Max. score:
2
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: 24, 48, 72 hrs
Score:
> 0 - <= 1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean score after 72 hours: 0.3
Irritation parameter:
conjunctivae score
Basis:
animal: #2 and #3
Time point:
other: 24, 48, 72 hrs
Score:
> 0 - <= 1
Max. score:
3
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: mean score after 72 hours: 0.3
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: 24, 48, 72 hrs
Score:
> 0 - <= 1
Max. score:
4
Reversibility:
fully reversible within: 2 days
Remarks on result:
other: mean score after 72 hours: 0.3
Irritation parameter:
chemosis score
Basis:
animal: #2 and #3
Time point:
other: 24, 48, 72 hrs
Score:
0
Max. score:
4

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No corneal damage or iridial inflammation was recorded in any of the animals. Mild conjunctival irritation was recorded in all three animals, this had resolved two or three days after instillation. Thus instillation of the test substance into the rabbit eye did not elicit a positive response in any of the three treated animals.
Executive summary:

The eye irritation potential of Polyol TP 30 (propylidynetrimethanol, ethoxylated) was investigated in a rabbit study (OECD 405). Instillation of 0.1 mL of the material into one eye of three rabbits did not result in any corneal damage or iridial inflammation. Mild conjunctival irritation was recorded in all three animals; this resolved within two or three days after instillation. The reactions seen in this study are not sufficient to result in classification according to the CLP Regulation.