Registration Dossier

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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented study report which meets basic scientific principles.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1975
Report Date:
1975
Reference Type:
other: OECD SIDS
Title:
1-Chloro-2-nitrobenzene, CAS: 88-73-3
Author:
OECD SIDS
Year:
2001
Bibliographic source:
SIDS Initial Assessment Report for SIAM 13

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: FDA guidelines
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Physical state: yellow crystals

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Housing: individually
- Diet: Mischfutter ERKA 8300 der Futtermittelwerke Robert Koch oHG/ Hamm, ad libitum
- Water: tap water, ad libitum

Test system

Vehicle:
other: sesame oil or unchanged (no vehicle)
Controls:
other: untreated eye served as a negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg (undiluted) or 0.1 mL (10% dilution)


VEHICLE
- Amount(s) applied (volume or weight with unit): 0.1 mL
Duration of treatment / exposure:
one instillation
Observation period (in vivo):
up to 24 hours
Number of animals or in vitro replicates:
6
Details on study design:
- Washing (if done): fluorescein instillation at 24 hours, followed by iggrigation with physiological NaCl solution
- Time after start of exposure: 24 hours

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 7, 24 h
Score:
0
Max. score:
4
Remarks on result:
other: undiluted
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 7, 24 h
Score:
0
Max. score:
2
Remarks on result:
other: undiluted
Irritation parameter:
conjunctivae score
Basis:
animal: 2, 3, 5, 6
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: undiluted
Irritation parameter:
conjunctivae score
Basis:
animal: 1, 4
Time point:
other: 1 h
Score:
2
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: undiluted
Irritation parameter:
conjunctivae score
Basis:
animal: 2, 4
Time point:
other: 7 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: undiluted
Irritation parameter:
conjunctivae score
Basis:
animal: 1, 3, 5, 6
Time point:
other: 7
Score:
0
Max. score:
3
Remarks on result:
other: undiluted
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24 h
Score:
0
Max. score:
3
Remarks on result:
other: undiluted
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1, 7, 24 h
Score:
0
Max. score:
4
Remarks on result:
other: undiluted
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 1, 7, 24 h
Score:
0
Max. score:
4
Remarks on result:
other: 10% solution
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 1, 7, 24 h
Score:
0
Max. score:
2
Remarks on result:
other: 10% solution
Irritation parameter:
conjunctivae score
Basis:
animal: 3, 4, 6
Time point:
other: 1 h
Score:
1
Max. score:
3
Reversibility:
fully reversible within: 7 h
Remarks on result:
other: 10% solution
Irritation parameter:
conjunctivae score
Basis:
animal: 1, 2, 5
Time point:
other: 7 h
Score:
0
Max. score:
3
Remarks on result:
other: 10% solution
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 7, 24 h
Score:
0
Max. score:
3
Remarks on result:
other: 10% solution
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 1, 7, 24 h
Score:
0
Max. score:
4
Remarks on result:
other: 10% solution
Irritant / corrosive response data:
Slight to moderate redness of conjunctivae was observed in all animals 1 hour post-instillation. At 7 hours observation, 2 out of 6 rabbits still had slight redness of conjunctivae, which was fully resolved at 24 hours observation point.
No other effects were noted.

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information