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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

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: Guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1987
Report date:
1987

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
only 8 days observation period
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Cyclohexane, oxidized, non-acidic by-products, distn. residues
EC Number:
271-816-4
EC Name:
Cyclohexane, oxidized, non-acidic by-products, distn. residues
Cas Number:
68609-04-1
IUPAC Name:
(1s,4s)-cyclohexane-1,4-diol (cyclohexyloxy)cyclohexane 2-butylcyclohexan-1-one 8-oxatricyclo[7.4.0.0^{2,7}]trideca-1(9),2(7)-diene cyclohexane cyclohexane-1,3-diol cyclohexanol phenol hydrate
Details on test material:
- Name of test material (as cited in study report): Anone destillation residue
- Analytical purity: not reported

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, Offenbach
- Mean weight at study initiation: male 2.79 Kg, female 2.65 Kg
- Housing: single
- Diet: Kliba 341 (about 130 g/animal/day)
- Water: 250 ml tap water/animal/day
- Acclimation period: 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye of the same animal
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml undiluted
Duration of treatment / exposure:
kept unwashed
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize scoring

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 h
Score:
1
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: see table in free text for individual score
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 h
Score:
0.2
Max. score:
2
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: see table in free text for individual score
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 h
Score:
1.6
Max. score:
3
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: see table in free text for individual score
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 h
Score:
0.2
Max. score:
4
Reversibility:
fully reversible within: 48 h
Remarks on result:
other: see table in free text for individual score

Any other information on results incl. tables

 

Readings

Animal No.

Cornea

Iris

Conjunctivae

Chemosis

Symptoms

 

1 h

1

0

0

2

1

 

2

0

0

2

1

 

3

0

0

2

1

 

 

24 h

1

1

1

2

1

PC/RE

2

1

0

2

0

PC/RE

3

1

1

2

1

PC/RE

 

48 h

1

1

0

2

0

PC/RE

2

1

0

2

0

PC/RE

3

1

0

1

0

PC/RE

 

72 h

1

1

0

1

0

RE

2

1

0

1

0

RE/PC

3

1

0

1

0

RE/PC/MV/LC

 

8 d

1

0

0

0

0

RE

2

0

0

0

0

RE

3

0

0

0

0

RE/MV

Mean

(24-48-72 h)

1

1.0

0.3

1.7

0.3

 

2

1.0

0.0

1.7

0.0

 

3

1.0

0.3

1.3

0.3

 

Mean

 

1.0

0.2

1.6

0.2

 

PC - pupil contracted
RE - small retractions in the eyelids
MV - marginal vascularization of the cornea
LC - loss of corneal tissue

Applicant's summary and conclusion