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
Study period:
December 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well conducted study according to GLP

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
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
Principles of method if other than guideline:
The test substance was instilled into the eye of one rabbit.
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene
EC Number:
412-570-1
EC Name:
1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene
Cas Number:
119462-56-5
Molecular formula:
Hill formula: C18 H16 N2 O4
IUPAC Name:
3-methyl-1-({3-[(3-methyl-2,5-dioxo-2,5-dihydro-1H-pyrrol-1-yl)methyl]phenyl}methyl)-2,5-dihydro-1H-pyrrole-2,5-dione
Details on test material:
- Name of test material (as cited in study report): m-xylylene bis(citraconimide)
Nature of substance: brown powder
Batch no.: BOM pp2
Purity: 87 ± 3% (m/m); see CoA attached
Other: m-Xylylene bis(itaconimide) 2-5%

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
other: no vehicle used
Controls:
no
Amount / concentration applied:
50 mg
Duration of treatment / exposure:
After placing the test substance into the lower everted lid of one eye, eyelids were gently held together for one second before releasing.
Observation period (in vivo):
24 h
Number of animals or in vitro replicates:
1 animal.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24 h
Score:
0
Max. score:
2
Reversibility:
not specified
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
conjunctivae score
Remarks:
(redness)
Basis:
animal #1
Time point:
24 h
Score:
2
Max. score:
3
Reversibility:
not specified
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24 h
Score:
4
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
48 h
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
48 h
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
48 h
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
48 h
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
72 h
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
iris score
Basis:
animal #1
Time point:
72 h
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
72 h
Remarks on result:
other: animal was killed at 24 h
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
72 h
Remarks on result:
other: animal was killed at 24 h
Other effects:
Due to the severity of the effects the animal was killed 24 hours after instillation for humane reasons. Corneal opcity covered nearly the whole area. Blanching of the eyelids and a copious discharge were seen.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Because of the premature killing of the animal no judgement can be made on reversibility. The test substance was highly irritating and should be classified as 'risk of serious damage to eyes'.
Executive summary:

In an eye irritation test according to OECD 405 the test substance led to highly irritating effects in one rabbit (redness grade 2, chemosis grade 4, coneal opacity grade 4 with discharge). This rabbit was killed 24 h after treatment for animal welfare reasons and no further animals were treated. Thus, the test substance should be regarded as severely damaging the eyes of rabbits.