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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
Study period:
1994-09-12 to 1994-09-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
adopted 24 February 1987
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
- Name of test material (as cited in study report): BISOMER TEGDMA

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: 12 to 16 weeks
- Weight at study initiation: 2.45 to 2.70 kg
- Housing: individually in suspended metal cages
- Diet (e.g. ad libitum): rabbit diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 – 21°C
- Humidity (%): 49 – 69%
- Air changes (per hr): app. 15/h
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated contralateral eye served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
eyes were not rinsed after application
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): no

SCORING SYSTEM: Draize scale, OECD guideline 405

TOOL USED TO ASSESS SCORE: light source from a standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 animals
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
- in 1/3 animals grade 1 redness (vessels definitily injected above normal) was observed 1 h after application; 2/3 animals showed no irritating effects at 1 h after treatment
- all eyes appeared normal at the 24, 48 and 72 h observations
Other effects:
no other effects reported

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
TREGDMA is not irritating to the rabbit eye.
Executive summary:

In a primary eye irritation study according to OECD guideline 405, adopted 24 February 1987, and EU method B.5, 0.1 mL of TREGDMA (purity ca. 95% according to supplier) was instilled into the conjunctival sac of 3 young adult New Zealand White rabbits (1 male, 2 females) without washing. Animals then were observed for 3 days.  Irritation was scored by the method of Draize. 

No effects were observed in cornea and iris. Only minimal (grade 1) redness was observed in 1/3 animals 1 h after treatment. All eyes appeared normal at the 24, 48 and 72 h observations.

In this study, TREGDMA is not irritating to the rabbit eye.