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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:
From 04 OCT 1983 to 07 OCT 1983.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD TG 405) GLP compliant, observation time not extended to the time point of full reversibility of all effects

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report date:
1983

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
observation time only till 72 hours after start of exposure, but not until full reversibility of all effects
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
EC Number:
236-852-7
EC Name:
2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide
Cas Number:
13515-40-7
Molecular formula:
C17H15ClN4O5
IUPAC Name:
2-[(4-chloro-2-nitrophenyl)diazenyl]-N-(2-methoxyphenyl)-3-oxobutanamide
Test material form:
solid: nanoform, no surface treatment

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Strain: Hoe: HIMK (SPFWiga)
- Source: Hoechst AG, in-hous conventional breeding
- Weight at study initiation: 2.7-3.3 kg
- Housing: individually
- Diet: Altromin 2123 diet for breeding rabbits (Altromin, Lage/Lippe), ad libitum
- Water: deionised, chlorinated water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 2
- Humidity (%): 55 +/- 10
- Photoperiod (hrs dark / hrs light): 12 h / 12 h

Test system

Vehicle:
other: polyethylene glycol 400
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100 mg pasted with 0.2 ml polyethylene glycol 400
Duration of treatment / exposure:
24 h
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): with ca. 37 °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, magnifying glass

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
iris score
Basis:
mean
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible
Remarks:
not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 h
Score:
0.7
Max. score:
4
Reversibility:
not specified
Remarks on result:
other: cornea opacity was only observed 48 and 72 hours after application, observation time ended at 72 h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks:
not applicable
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks:
not applicable
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Remarks:
not applicable
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Time point:
other: mean of 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible within: 48 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Time point:
other: mean of 24, 48, 72 h
Score:
0.3
Max. score:
3
Reversibility:
fully reversible
Remarks:
48 h after application.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Time point:
other: mean of 24, 48, 72 h
Score:
0
Max. score:
3
Reversibility:
fully reversible
Remarks:
not applicable
Irritant / corrosive response data:
- no iridial effects occurred during the study
- chemosis scores for animal #1,2,3 after 1 h: (2,1,1). After 24, 48 and 72 h scores for all animals were 0.
- redness of the conjunctivae scores for animal #1,2,3 after 1 h: (2,1,1), after 24 h: (1,1,0). After 48 h and 72 h scores for all animals were 0.
- cornea opacity scores for animal #1,2,3 after 1 h and 24 h was 0 for all animals. After 48 h: (1,0,0) and after 72 h: (1,0,0)
- Heavy discharge was observed in every animal one hour after application.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test item did not induce iridial effects under the conditions of this test. Effects on conjunctivae redness and chemosis were sligth to moderate and fully reversible within 72 hours after start of the exposure. One animal showed very slight corneal opacity at 48 and 72 hours after start of the exposure, but not at earlier timepoints. As no corneal effects were observed in the two other animals it can reasonable be assumed that the slight effects seen in this animal would also be reversible within some days. Therefore it is concluded that the test item has not to be classified as an eye irritant according to the classification criteria of Regulation (EC) No 1272/2008.
Executive summary:

The test material was subject to an Acute Eye Irritation / Corrosion Test in the rabbit according to OECD TG 405. No iridial effects were noted during the study. Very slight corneal opacity was observed in one animal 48 and 72 hours after test substance application but not in the two other test animals at any timepoint. Conjunctival redness was observed in every animal one hour after application, and in two animals 24 hours after application, fully reversible by 48 h after application. Chemosis was observed in every animal only one hour after application but not at later time points.