2,6-diethyl-p-toluidine

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1988

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP-compliant guideline study

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1989

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

2,6-diethyl-p-toluidine

EC Number:

246-307-5

EC Name:

2,6-diethyl-p-toluidine

Cas Number:

24544-08-9

Molecular formula:

C11H17N

IUPAC Name:

2,6-diethyl-4-methylaniline

Test material form:

other: liquid

Details on test material:

- Name of test material (as cited in study report): 2,6-Diethyl-4-methylanilin
- Physical state: liquid
- Expiration date of the lot/batch: 07-October-1989
- Stability under test conditions: stable
- Storage condition of test material: room temperature, at a dry place

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Interfauna UK Ltd.).
- Sex: females
- Weight at study initiation: 2.2 up to 2.9 Kg
- Fasting period before study: none
- Housing: gang housing à 5 animals per cage and sex
- Diet (e.g. ad libitum): "ssniff K 4" from SSNIFF Spezialdiäten GmbH, Soest/Westfalen, Germany
- Amount of diet: ca. 100 to 120 g per animal and day, once daily
- Water (e.g. ad libitum): tap water
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3°C
- Humidity (%): 50%
- Air changes (per hr): 10 changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours (artificial light)

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

500 ul

Duration of treatment / exposure:

4 hours

Observation period (in vivo):

24, 48 and 72 hours

Number of animals or in vitro replicates:

3 female rabbits

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-72 hours

Score:

0.23

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-72 hours

Score:

0

Max. score:

0

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-72 hours

Score:

0.1

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

One animal showed slight corneal opacity up to 48 hours after treatment. Redness of the conjunctiva was noted in two animals, being reversible within 48 hours.

Other effects:

None

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item is not irritant to rabbit skin.

Executive summary:

The eye irritation study was conducted as GLP-study according to OECD no. 405. The test was performed on three NZW rabbits. Slight corneal opacity and conjunctival redness were observed in to animals. These effcts were found to be reversible within 48 hours.

Therefore, the substance can be considered as non-irritant to the eyes.