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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other: GLP compliant, guideline study, available as unpublished report, minor restrictions in reporting otherwise adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): "Cracked distillate"
- Physical state: clear yellow/brown slightly viscous liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: ENKI-Konijnenfarm, Someran, The Netherlands
- Age at study initiation: young adult
- Weight at study initiation: 2600-3050 g
- Housing: Individually in suspended, galvanised cages
- Diet: Standard laboratory rabbit diet ad libitum
- Water: Tap water ad libitum
- Acclimation period: At least 6 days

ENVIRONMENTAL CONDITIONS
- Temperature: 19 ± 3°C
- Humidity: at least 40%
- Air changes: 10 per hr
- Photoperiod (hrs dark / hrs light): natural light cycle

IN-LIFE DATES: From: 22 May 1989 To: 25 May 1989

Test system

Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
Observation period (in vivo):
72 hours
Number of animals or in vitro replicates:
3
Details on study design:
SCORING SYSTEM: Draize scale

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
Remarks on result:
other: no corneal effects
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
2
Remarks on result:
other: no iridial effects
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.4
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: minimal effects in 2 rabbits at 24 and 48 hours
Irritation parameter:
chemosis score
Basis:
mean
Time point:
other: 24, 48 and 72 hours
Score:
0.4
Max. score:
4
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: minimal effects in 2 rabbits at 24 and 48 hours

Any other information on results incl. tables

Eye irritation scores according to the Draize scheme

Time

Cornea

Iris

Conjunctiva

 

 

 

 

Redness

Chemosis

 

Animal number

5069

5071

5072

5069

5071

5072

5069

5071

5072

5069

5071

5072

after 1 hour

0

0

0

0

0

0

2

2

2

2

1

1

after 24 hours

0

0

0

0

0

0

0

1

1

0

1

1

after 48 hours

0

0

0

0

0

0

0

1

1

0

1

1

after 72 hours

0

0

0

0

0

0

0

0

0

0

0

0

mean scores 24-72h

0

0

0

0

0

0

0

0.7

0.7

0

0.7

0.7

 

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Cracked Distillate is not irritating to the rabbit eye.
Executive summary:

The eye irritant potential of Cracked distillate (CAS 68477-40-7) was investigated in 3 albino rabbits. Slight or moderate redness and chemosis was seen in all three rabbits which recovered within 72 hours.

It can be concluded that Cracked distillate (CAS 68477-40-7) is not irritating to the rabbit eye and no classification is warranted under Dir 67/548/EEC or under GHS/CLP.