Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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 guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2009
Report Date:
2009

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: liquid
- Content: 100%
- molecular weight: approx. 235

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Sex: female
- Source: Charles River, Kißlegg, Germany
- Age at study initiation: adult
- Weight at study initiation: 2300-2700 g
- Housing: individual
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 25
- Photoperiod (hrs dark / hrs light): 12 / 12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: one untreated eye of test animals served as control
Amount / concentration applied:
Amount: 0.1 ml

Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72 hours post application. If no irritation indices were observed after 72 hours, the study was finished. If eye irritations were observed, animals were monitored usually on day 7, 14 and 21 after application until the changes had completely subsided, however for not more than 21 days after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: The eye was not rinsed for at least 24 hours following instillation

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #1-#3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal: #1-#3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal: #1 and #2
Time point:
other: 24 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean score after 72 hours: 1
Irritation parameter:
conjunctivae score
Basis:
animal: #1 and #2
Time point:
other: 48 hours
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean score after 72 hours: 1
Irritation parameter:
conjunctivae score
Basis:
animal: #1 and #2
Time point:
other: 72 hours
Score:
0
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean score after 72 hours: 1
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: 24, 48, 72 hours
Score:
0 - 1
Max. score:
3
Reversibility:
fully reversible within: 3 days
Remarks on result:
other: mean scores after 72 hours: 0.7
Irritation parameter:
chemosis score
Basis:
animal: #1-#3
Time point:
other: 24, 48, 72 hours
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 1 day
Remarks on result:
other: in respect of the result (score 1) 1 hour post application
Other effects:
There were no systemic intolerance reactions.

Applicant's summary and conclusion

Conclusions:



Classification: not irritating
Executive summary:

Ethane-1,2 -diol, propoxylated shows slight irritant effects which are reversible within 3 days. There were no systemic intolerance reactions.