Registration Dossier

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: Non-GLP compliant guideline study, fully adequate for assessment.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
yes
Remarks:
, limited observation time
GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
3,7-dimethyloct-6-enenitrile
EC Number:
257-288-8
EC Name:
3,7-dimethyloct-6-enenitrile
Cas Number:
51566-62-2
Molecular formula:
C10H17N
IUPAC Name:
3,7-dimethyloct-6-enenitrile
Details on test material:
- Name of test material: Citronellylnitril
- Test substance No.: 82/88
- Stable until: March 1984

Test animals / tissue source

Species:
rabbit
Strain:
Vienna White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, FRG.
- Weight at study initiation: males: 2.85 and 2.98 kg, female: 3.27 kg.
- Housing: Individually in stainless steel cages with wire mesh walk floor (floor area: 40 cm x 51 cm). No bedding in the cages; sawdust in the waste trays.
- Diet: Ovator Solikanin 4 mm; Muskator-Werke, D-4000 Düsseldorf 1, FRG (about 130 g per animal daily).
- Water: About 250 mL tap water per animal daily.
- Acclimation period: About 8 days before the beginning of the study in the skin laboratory; same housing conditions as during the study.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24.
- Humidity (%): 30 - 70.
- Photoperiod (hrs dark / hrs light): 12 h/12 h (6.00a.m. - 18.00p.m./18 p.m. - 8a.m.).

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: Negative control: Untreated eye.
Amount / concentration applied:
Undiluted
Amount applied: 0.1 mL
Duration of treatment / exposure:
8 days
Observation period (in vivo):
8 days
Number of animals or in vitro replicates:
3
Details on study design:
Application site: Conjunctival sac of the right eyelid.
No wash out of substance.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: 1-3
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
iris score
Basis:
animal: 1-3
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
2
Reversibility:
other: not applicable
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
other: Mean of 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
other: Mean of 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
other: Mean of 24, 48 and 72 hours
Score:
1
Max. score:
3
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
chemosis score
Basis:
animal: 1-3
Time point:
other: Mean of 24, 48 and 72 hours
Score:
0
Max. score:
4
Reversibility:
other: not applicable

Any other information on results incl. tables

Individual eye irritation scores:

Readings

Animal

Cornea

Iris

Conjunctiva

 

 

Opacity

Area

 

Redness

Swelling

Discharge

1 hours

1

0

0

0

3

1

2

 

2

0

0

0

3

1

2

 

3

0

0

0

3

1

2

24 hours

1

0

0

0

1

0

0

 

2

0

0

0

1

0

0

 

3

0

0

0

1

0

0

48 hours

1

0

0

0

1

0

0

 

2

0

0

0

1

0

0

 

3

0

0

0

1

0

0

72 hours

1

0

0

0

1

0

0

 

2

0

0

0

1

0

0

 

3

0

0

0

1

0

0

8 days

1

0

0

0

1

0

0

 

2

0

0

0

1

0

0

 

3

0

0

0

1

0

0

Applicant's summary and conclusion