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: Guideline study (OECD TG 405), with 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
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-nitrobenzoate
EC Number:
281-339-3
EC Name:
Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-nitrobenzoate
Cas Number:
83929-47-9
Molecular formula:
C15H10Cl2N2O5
IUPAC Name:
methyl 4-[(2,5-dichlorophenyl)carbamoyl]-2-nitrobenzoate
Details on test material:
- Name of test material (as cited in study report): Nitro-MMT-Dichloranilid-25 TF8

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG, Kastengrund, conventional breeding
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.9-3.6 kg
- Housing: individually
- Diet: Altromin 2123 husbandry diet - rabbit (Altromin, Lage/Lippe), ad libitum, plus hay ca. 15 g per day
- Water: deionised, chlorinated water ad libitum

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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: the untreted eye of each animal served as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg
Duration of treatment / exposure:
24 h after instillation eyes were washed with physiol. saline
Observation period (in vivo):
72 h
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing: with ca. 37 deg. C warm physiol. saline
- Time after start of exposure: 24 h

SCORING SYSTEM: according to OECD TG 405

TOOL USED TO ASSESS SCORE: fluorescein, UV light

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: # 8, 41, 51 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: no signs of irritation (cornea) at any time
Irritation parameter:
iris score
Basis:
animal: # 8, 41, 51 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
other: no signs of irritation (iris) at any time
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: # 8
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
other: initial slight effects were fully reversible within 24 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: # 41
Time point:
other: mean of 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal: # 51
Time point:
other: mean of 24, 48, 72 h
Score:
0.33
Max. score:
3
Reversibility:
fully reversible within: 48 h
Irritation parameter:
chemosis score
Basis:
animal: # 8, 41, 51 each
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
other: initial slight effects were fully reversible within 24 h
Irritant / corrosive response data:
No corneal opacity and no iridial responses occurred during the study. Chemosis was only observed in one animal at one hour after test item application. Conjunctival redness was detected in every animal one hour after application (max. score 2) and in two animals 24 hours after application (max. score 1). This effect was fully reversible in all animals 48 h after application.

Other effects:
Transparent discharge, yellow coloured from test substance, was observed in two animals one hour after application but not at later time points.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP regulation
Conclusions:
The test material caused no corneal or iridial effects under the conditions tested, slight chemosis and conjunctival redness were fully reversible within 48 hours. The test material has not to be classified as irritating to eyes.
Executive summary:

An Acute Eye Irritation/Corrosion Test was performed in three rabbits according to OECD TG 405. Neither corneal effects nor iridial responses occurred during the study. Chemosis was only observed in one animal at one hour after test item application. Conjunctival redness was detected in every animal one hour after application and in two animals 24 hours after application. This effect was fully reversible in all animals 48 h after application.