Registration Dossier

Diss Factsheets

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: The study was conducted in compliance with GLP and according to the OECD guideline 405 (acute eye irritation/corrosion).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report date:
1990

Materials and methods

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

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 1,1'-(2,2,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione and 1,1'-(2,4,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione
Molecular formula:
C17H22N2O4
IUPAC Name:
Reaction mass of 1,1'-(2,2,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione and 1,1'-(2,4,4-trimethylhexane-1,6-diyl)bis-1H-pyrrole-2,5-dione

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: males 14 weeks, females 15 weeks (at start of treatment)
- Weight at study initiation: males 2.6 - 2.7 kg, females 2.0 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C +/- 3°C
- Humidity (%): 40-70%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal served as control
Amount / concentration applied:
0.1 g / animal
Duration of treatment / exposure:
Single exposure, no washing
Observation period (in vivo):
1, 24, 48 and 72 hours, 7, 14 and 21 days after administration.
Number of animals or in vitro replicates:
3
Details on study design:
The test article (0.1 g per animal) was placed in the conjunctival sac of the left eye of each animal after gently pulling the lower lid away from the
eyeball. The lids were then gently held together for about one second to prevent loss of the test article. The right eye remained untreated and served
as the reference control. The eyes of each animal were examined 1, 24, 48 and 72 hours, and at 7, 14 and 21 days after administration.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24, 48 and 72 hours
Score:
2.7
Max. score:
4
Reversibility:
not reversible
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24, 48 and 72 hours
Score:
0.88
Max. score:
2
Reversibility:
fully reversible within: 21 days
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24, 48 and 72 hours
Score:
2.22
Max. score:
3
Reversibility:
not reversible
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal 1-3
Time point:
other: 24, 48 and 72 hours
Score:
3.11
Max. score:
4
Reversibility:
not fully reversible within: 21 days
Irritant / corrosive response data:
Partly corrosion of the conjuctivae was observed ·in all animals from 24 hours to 7 days after treatment.
Other effects:
No staining of the cornea and conjunctivae of the treated eyes by pigment or coloring of the test article was observed.
Corneal opacity was observed in two animals from 1 hour to 21 days, and in one animal from 24 hours to 21 days after test article application.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this experiment, MATMD was found to cause a primary irritation score of 8.17, when applied to the conjunctival sac of the
rabbit eye.
Executive summary:

In all 3 animals (in 2 from 1 hour and in 1 from 24 hours after administration) irreversible corneal opacity was noted and hence the substance had to be classified as inducing irreversible changes to the eye.