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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
Study period:
01/03 1989 to 07/03 1989
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: conform guideline, non GLP

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
p-menthane
IUPAC Name:
p-menthane
Constituent 2
Chemical structure
Reference substance name:
1-isopropyl-4-methylcyclohexane
EC Number:
202-790-4
EC Name:
1-isopropyl-4-methylcyclohexane
Cas Number:
99-82-1
Molecular formula:
C10H20
IUPAC Name:
1-isopropyl-4-methylcyclohexane
Details on test material:
- Name of test material (as cited in study report): p-menthane
- Physical state: liquid

Test animals / tissue source

Species:
rabbit
Strain:
other: white russian
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Dr. Karl Tomae GmbH Biberach
- Sex: male
- Weight at study initiation: 2.4 kg
- Housing: individual
- Diet : K4 Alleindiät für Kaninchen, Ssniff Spezialfütter GmbH Soest, 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: 01 March 1989 To: 07 March 1989

Test system

Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
0.1 cm3 in the conjunctival sac, washed with physiological saline after 72 h
Duration of treatment / exposure:
washed with physiological saline after 72 h
Observation period (in vivo):
at 1, 24, 72 h and 6 days after application
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): physiological saline
- Time after start of exposure: after 72 h

SCORING SYSTEM: draize

TOOL USED TO ASSESS SCORE: at the 72 h observation fluorescein was used to assess corneal effects

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
iris score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible
Irritation parameter:
conjunctivae score
Remarks:
chemosis and discharge
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
0
Reversibility:
fully reversible
Irritant / corrosive response data:
No irritant effects were observed

Any other information on results incl. tables

 

1 hour

 

Conjuntivae

24 hours

Conjuntivae

48 hours

Conjuntivae

72 hours

Conjuntivae

6 days

Conjuntivae

 

Cornea

Iris

R

C

D

Cornea

Iris

R

C

D

Cornea

Iris

R

C

D

Cornea

Iris

R

C

D

Cornea

Iris

R

C

D

Animal 1

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Animal 2

0

0

2

1

2

0

0

1

0

0

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

Animal 3

0

0

1

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not irritating to eyes.
Executive summary:

In an eye irritation test with rabbits no irritating effects of the test substance became apparent.