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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Eye irritation

Currently viewing:

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: According to guideline 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, aquous extract
IUPAC Name:
Cyclohexane, oxidized, aquous extract
Constituent 2
Reference substance name:
Cyclohexane, oxidized, aq. ext.
EC Number:
272-810-4
EC Name:
Cyclohexane, oxidized, aq. ext.
Cas Number:
68915-38-8
Molecular formula:
not available
IUPAC Name:
Cyclohexane, oxidized, aq. ext.
Details on test material:
- Name of test material (as cited in study report): Abstreifsaeure
- Physical state: Yellow liquid
- Composition of test material, percentage of components:
16.7% Adipinic acid (CAS-Nr. 12404-9)
13.2% 6-Hydroxycaproic acid (CAS-Nr.1191-25-9)
2.1% Glutaric acid (CAS-Nr. 110-94-1 )
0.8% succinic acid (CAS-Nr. 13392-69-3)
0.2% valeric acid (CAS-Nr. 109-52-4)
0.2% butanoic acid (CAS-Nr. 107-92-6)
0.1% propionic acid (CAS-Nr. 79-09-4)
0.3% acidic acid (CAS-Nr. 64-19-7)
1.4% formic acid (CAS-Nr. 64-18-6)
10% polymeric oxycaproic acid
~20ppm cobalt0.2% valeric acid

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 2.89 Kg, female 2.73 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
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. Readings: 1h, 24h, 48h, 72h and 8 days after application.


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:
2.8
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: see free text for details
Irritation parameter:
iris score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 h
Score:
1.6
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: see free text for details
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
3 rabbits
Time point:
other: 24-48-72 h
Score:
1.6
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: see free text for details

Any other information on results incl. tables

Readings

Animal

Cornea

Iris

Conjuctiva

Symptoms

Red

Sw

 

1 h

1

1

0

2

2

 -

2

1

0

2

2

 -

3

1

0

2

2

LC

 

24 h

1

2

0

2

1

PC/LC

2

3

0

1

2

LC

3

2

0

1

1

PC/LC

 

48 h

1

2

0

2

1

PC/LC/S

2

4

0

1

2

LC/S

3

3

0

2

1

PC/LC

 

72 h

1

2

0

2

1

PC/LC/S/RE

2

4

0

1

2

LC/S

3

3

0

2

1

PC/LC/RE

 

8 d

1

2

0

2

1

MV/LH/PA/RE/SO6/PC/LC

2

4

0

1

2

MV/PA/RE/LC/S/SO6

3

4

0

2

1

PC/LC/RE/MV/SO6

 

Mean

(24-72 h)

1

2.0

0

2.0

2.0

 

2

3.7

0

1.0

1.0

 

3

2.7

0

1.7

1.7

 

Mean

 

2.8

0

1.6

1.6

 

Red - redness
Sw - chemosis
LC - loss of corneal tissue
PC - pupil contracted
S - suppuration
RE - small retractions in the eyelid
MV - marginal vascularization of the cornea
LH - loss of hair at margins of the eyelid
PA - pannus
SO6 - study discontinued after 8d because of severe irritation

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye)
Remarks:
Migrated information Criteria used for interpretation of results: EU