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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:
15 Jun 1992 to 22 Jun 1992
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1992
Report date:
1992

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: EEC Directives 83/467 and 84/449
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Reference substance name:
Benzene, mono-C10-14-alkyl derivs.
EC Number:
270-486-9
EC Name:
Benzene, mono-C10-14-alkyl derivs.
Cas Number:
68442-69-3
IUPAC Name:
dodecylbenzene
Constituent 2
Chemical structure
Reference substance name:
Dodecylbenzene
EC Number:
204-591-8
EC Name:
Dodecylbenzene
Cas Number:
123-01-3
Molecular formula:
C18H30
IUPAC Name:
4-[dodecan-(2 to 6)-yl] benzene

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Conelli - Arona
- Weight at study initiation: 2.5 - 3.5 kg
- Housing: stainless steel cages
- Diet: pellet complete diet
- Water: filtered tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 2
- Humidity (%): 55 ± 15
- Air changes (per hr): 25
- Photoperiod (hrs dark / hrs light): 12

IN-LIFE DATES: From: 15 Jun 1992 to 22 Jun 1992

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.1 mL
- Concentration: 100%
Duration of treatment / exposure:
7 days
Observation period (in vivo):
1, 24, 48, and 72 hours, and 7 days after start of exposure
Number of animals or in vitro replicates:
6
Details on study design:
SCORING SYSTEM:
- Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
110
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
2
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
3
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #1, #2, #3, #4, #5, #6
Time point:
24/48/72 h
Score:
0
Max. score:
4
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No signs of irritation or corrosion were seen in any animal during any of the observations.

Any other information on results incl. tables

Table 1: Results of Eye Irritation Study - Mean Scores                  

Observation

Cornea

Iris

Conjunctiva (Redness)

Conjunctiva (Chemosis)

1 hr

0

0

0

0

24 hrs

0

0

0

0

48 hrs

0

0

0

0

72 hrs

0

0

0

0

7 days

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test substance is not an eye irritant.
Executive summary:

This study examined the potential of the test substance to cause eye irritation. 0.1 mL of test substance was placed in one eye of 6 rabbits. The untreated eyes served as controls. The eyes were examined at 1, 24, 48, and 72 hours, and 7 days after start of exposure for signs of irritation. No signs of irritation were seen in any animal at any observation. The test substance is considered no irritating to eyes.