Benzene, C15-16-alkyl derivs.

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

June 15, 1992-June 22, 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Test procedure according to national standards.

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

Test material form:

other: liquid

Details on test material:

No additional detail available

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 (e.g. ad libitum): pellet complete diet
- Water (e.g. ad libitum): filtered tap water, ad libitum

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


IN-LIFE DATES: From: June 15, 1992 To: June 22, 1992

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated eye served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%

Duration of treatment / exposure:

7 days

Observation period (in vivo):

1, 24, 48, and 72 hrs, 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

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 24, 48, and 72 hrs

Score:

0

Max. score:

0

Reversibility:

fully reversible

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

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:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance is not an eye irritant according to EU GHS guidelines.

Executive summary:

In cases where no data were available on the target substance, Benzene, C15 -16 -alkyl derivs., data were read across from a structurally related material (the test substance).

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 hrs, 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.