Registration Dossier

Administrative data

Endpoint:
eye irritation, other
Remarks:
In vivo study previously available which addresses fully the endpoint requirements.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1995-03-09 to 1995-05-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study (OECD 405)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
February 27, 1987
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: flakes

Test animals / tissue source

Species:
rabbit
Strain:
other: "Kleine Weiße Russen, Chbb:HM, SPF"
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Thomae GmbH, Chemisch-Pharmazeutische Fabrik, 88400 Biberach an der Riss 1, Germany
- Age at study initiation: adults
- Weight at study initiation: 2.6, 2.4 and 2.5 kg
- Housing: conventional, kept single in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 14 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity:30 - 70 %
- Air changes: 15 per h
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: From: 1995-03-14 To: 1995-07-04

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
Amount applied: 0.1 g
Duration of treatment / exposure:
24 hours
Observation period (in vivo):
1, 24, 48, 72 h; 6, 8, 10, 13, 16, 21 and 24 days
Number of animals or in vitro replicates:
3 males
Details on study design:
rinsed with physiological saline solution after 24 h

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
animal #1
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
2.67
Max. score:
3
Reversibility:
fully reversible within: 24 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
2.33
Max. score:
3
Reversibility:
not fully reversible within: 24 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
3
Max. score:
3
Reversibility:
fully reversible within: 16 days
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 13 days
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 24 days
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 13 days
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 16 days
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
1
Max. score:
4
Reversibility:
not fully reversible within: 24 days
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 10 days
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
0.67
Max. score:
2
Reversibility:
not fully reversible within: 24 days
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
1
Max. score:
2
Reversibility:
not fully reversible within: 24 days
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
(mean)
Time point:
other: 24, 48 and 72h
Score:
0.33
Max. score:
2
Reversibility:
fully reversible within: 21 days

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Remarks:
Migrated information
Conclusions:
The eye irritation of 4-Hydroxy-TEMPO was tested in a standard OECD 405 guideline study. Classification: H318, Causes serious eye damage