Registration Dossier

Diss Factsheets

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: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no
Remarks:
study performed prior to implementation of GLP

Test material

Constituent 1
Chemical structure
Reference substance name:
1-chlorohexane
EC Number:
208-859-5
EC Name:
1-chlorohexane
Cas Number:
544-10-5
Molecular formula:
C6H13Cl
IUPAC Name:
1-chlorohexane

Test animals / tissue source

Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Age at study initiation: no data
- Weight at study initiation: 1.8 - 2.4 kg
- Housing: individually in stainless steel cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 / 12

IN-LIFE DATES: From: 02.08.1982 To: 04.08.1982

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: left eye of the same animal remained untreated and served as control
Amount / concentration applied:
Amount applied: 0.1 mL undiluted
Duration of treatment / exposure:
48 hours
Observation period (in vivo):
48 hours
Number of animals or in vitro replicates:
6
Details on study design:
REMOVAL OF TEST SUBSTANCE
- not rinsed

SCORING SYSTEM: according to Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
1-6
Time point:
other: 24 h and 48 h
Score:
< 0.1
Max. score:
4
Reversibility:
fully reversible within: 48 h
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
1-6
Time point:
other: 24 h and 48 h
Score:
0
Max. score:
4
Irritation parameter:
iris score
Basis:
mean
Remarks:
1-6
Time point:
other: 24 h and 48 h
Score:
0
Max. score:
2
Irritant / corrosive response data:
No reading at 72 h, but no reaction after 24 and 48 h.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under the conditions of this eye irritation study in the rabbit the test item was not irritating.