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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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: Conducted at GLP-accredited facility to current guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007

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 (incl. QA statement)

Test material

Constituent 1

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: an accredited supplier, but otherwise not stated
- Age at study initiation: 12-20 weeks
- Weight at study initiation: 2.0-3.5 kg
- Housing: individually in suspended cages
- Diet (e.g. ad libitum): Certified Rabbit Diet, ad libitum
- Water (e.g. ad libitum): mains tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17-23
- Humidity (%): 30-70
- Air changes (per hr): at least 15
- Photoperiod (hrs dark / hrs light): 12/12


IN-LIFE DATES: From: 19 March 2007 To: 29 March 2007

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 ml
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): none

SCORING SYSTEM: From Draize JH (1977) "Dermal and eye toxicity tests" In: Principles and Procedures for Evaluating the Toxicity of Household Substances, National Academy of Sciences, Washington DC pp48-49

TOOL USED TO ASSESS SCORE: light source from standard ophthalmoscope

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
66003 male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
66002 male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
not fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
66029 male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #3
Remarks:
66003 male
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #2
Remarks:
66002
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritation parameter:
conjunctivae score
Remarks:
Redness
Basis:
animal #1
Remarks:
66029 male
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
not fully reversible within: 72h
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
66003 male
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
not fully reversible within: 72h
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
66002 male
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 72h
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
66029 male
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
66003 male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
66002 male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72h
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
66029 male
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
fully reversible within: 72 h

Applicant's summary and conclusion

Interpretation of results:
slightly irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The test substance was considered minimally irritating according to the modified classification system of Kay & Calandra (class 3 on a 1-8 scale) but does not meet the criteria for classification according to EU or GHS.