Benzene, C10-13-alkyl derivs.

Eye irritation

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

Test material information

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

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

Results

Results 1

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

Results 2

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

Results 3

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

Results 4

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

Results 5

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.