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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:
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:
2004
Report Date:
2004

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:
- Name of test material (as cited in study report): Tripropylenglykoldiacrylat
- Physical state: liquid
- Analytical purity: >95%
- Lot/batch No.: 030061P040
- Stability under test conditions: The stability under storage conditions over the study perdiod was guaranteed by the sponsor.
- Storage condition of test material: room temperature, exclusion of light

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S.A., Vonnas, France
- Weight at study initiation: 3.12 - 3.22 kg
- Housing: individually in stainless steel wire mesh cages with grating, floor acrea: 3000 cm2
- Diet: Kliba-Labordiaet, about 130 g/animal per day
- Water: ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animals
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
7 days
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with 3 to 6 ml of hand warm tap water for 1 to 2 minutes using a syringe with a blunt probe.
- Time after start of exposure: 24 hours after application


SCORING SYSTEM: according to OECD guideline 405


TOOL USED TO ASSESS SCORE: daylight tubes "Lumilux" (L 58/860 Plus Eco 25x1, Osram, Germany)

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean value 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #1
Time point:
other: mean value 24/48/72 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: mean value 24/48/72 hours
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
other: mean value 24/48/72 hours
Score:
1.67
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean value 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #2
Time point:
other: mean value 24/48/72 hours
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: mean value 24/48/72 hours
Score:
2.33
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
other: mean value 24/48/72 hours
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean value 24/48/72 hours
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
iris score
Basis:
animal #3
Time point:
other: mean value 24/48/72 hours
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: mean value 24/48/72 hours
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 7 days
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
other: mean value 24/48/72 hours
Score:
1.33
Max. score:
4
Reversibility:
fully reversible within: 72 hours

Any other information on results incl. tables

Suppuration, contracted pupil, discharge of blood and  injected scleral vessels
in a circumscribed area or circular were noted during the observation period 
within the first 72 hours. All findings were fully reversible within 7 days at the
latest.

The average score (24 to 72 hours) for irritation was calculated to be 1.0 for corneal opacity, 0.44 for iris, 2.33 for conjunctival redness and 1.67 for chemosis.
EU-classification: The mean scores calculated over all animals tested were below 2 for corneal opacity, below 1 for iris lesions, below 2.5 for redness of the conjunctivae and below 2 for edema formation. There was only one animal with a mean score of 2.67 for redness, the other two animals were at 2 and 2.33. Therefore the substance is considered to be not irritating to the eye of rabbits according to EU-criteria under the conditions of the study. GHS-classification (UN): As the mean score of corneal opacity was 1 in 3/3 animals and the mean score for redness was 2, 2.33 and 2.67 in the animals respectively and all readings were reversed to 0 at the 7 day reading, the substance has to be classified as mildy irritating to eyes (Category 2B) according to GHS-criteria. The substance is classified in Annex I as irritating to eyes, respiratory system and skin.

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Remarks:
Migrated information