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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:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study (OECD)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report date:
2001

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
[(butoxymethylethoxy)methylethoxy]propan-1-ol
EC Number:
259-910-3
EC Name:
[(butoxymethylethoxy)methylethoxy]propan-1-ol
Cas Number:
55934-93-5
Molecular formula:
C13H28O4
IUPAC Name:
[(butoxymethylethoxy)methylethoxy]propan-1-ol
Details on test material:
- Name of test material (as cited in study report): Solvenon TPNB

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Centre Lago S.A.,01540 Vonnas, France
- Age at study initiation: about 5 months
- Weight at study initiation: 3.02-3.36 kg
- Fasting period before study: none
- Housing: singel housing in stainless steel wire mesh cages with gating
- Diet: Kliba-Laboratory diet, Provima Kliba SA, Kaiseraugst, Swiss ad libitum
- Water: Tap water ad libitum
- Acclimation period: at least 5 days


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

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: untreated eye
Amount / concentration applied:
undiluted
Amount applied: 0.1 ml
Duration of treatment / exposure:
24 hrs
Observation period (in vivo):
72 hrs
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): tap water
- Time after start of exposure: 24 hours


SCORING SYSTEM:
Cornea opacity (op): Degree of density (the most dense area is taken for reading)

0 = No ulceration or opacity
1 = Scattered or diffuse areas of opacity (other than slight dulling of normal lustre) details of iris clearly visible
2 = Easily discernible translucent area, details of iris slightly obscured
3 = Nacreaous area, no details of iris visible, size of pupil barely discernible
4 = Opaque cornea, iris not discernible throught the opacity

Area of cornea involved (ar):
1 = > 0 <= 1/4
2 = > 1/4 < 1/2
3 = > 1/2 < 3/4
4 = > 3/4

Iris:
0 = Normal
1 = Merkedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia or injection, any of these observations or combination of any thereof, iris still reacting to light (sluggish reaction is positive)
2 = No reaction to light, haemorrhage, gross destruction (any or all of these)

Chemosis (sw):
Lids and/or nictating membranes
0 = no swelling
1 = Any swelling abnormal (includes nictitating membranes)
2 = Obvious swelling with partial eversion of lids
3 = Swelling of lids about half closed
4 = Swelling of lids more than half closed

Discharge (di):
0 = No discharge
1 = Any amount different from normal (does not include small amounts observed in inner canthus of normal animals)
2 = Discharge with moistening of the lids and hairs just adjacent to lids
3 = Discharge with moistening of the lids and hairs and considerable area around the eye

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: no effects observed
Irritation parameter:
iris score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
2
Reversibility:
other: no effects observed
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24 - 48 - 72 h
Score:
0.3
Max. score:
3
Reversibility:
other: all 3 animals showed redness (score 2) at the 1-h reading; redness was reversible within 48 h; see table below for details
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
(animal 1-3)
Time point:
other: 24 - 48 - 72 h
Score:
0
Max. score:
4
Reversibility:
other: all 3 animals showed chemosis (2 animals: score 1; 1 animal: score 2) at the 1-h reading; chemosis was reversible within 24 h; see table below for details

Any other information on results incl. tables

Readings

Animal

Cornea

Iris

Conjunctiva

Additional findings

op

ar

red

ch

di

1 h

1

0

0

0

2

2

3

2

0

0

0

2

1

2

3

0

0

0

2

1

2

24 h

1

0

0

0

1

0

0

2

0

0

0

0

0

0

3

0

0

0

2

0

0

48 h

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

72 h

1

0

0

0

0

0

0

2

0

0

0

0

0

0

3

0

0

0

0

0

0

Mean

24 -72 h

1

0

0

0.3

0

2

0

0

0.0

0

3

0

0

0.7

0

Mean

0

0

0.3

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Migrated information
Conclusions:
EU-Classification: not irritating