2,6-diethyl-p-toluidine

Skin irritation / corrosion

Administrative data

Endpoint:

skin 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 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal 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

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

500 ul

Duration of treatment / exposure:

24 hours

Observation period:

1, 24, 48, 72 hours and 7 days

Number of animals:

3 female rabbits

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-72 hours

Score:

0.6

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 3 animals

Time point:

other: 24-72 hours

Score:

0

Max. score:

0

Irritant / corrosive response data:

Th test item showed slight erythema with max. score of 1 in all three animals 24 hours after treament. These effects were reversible within 48 hours in one animal and within 72 hours in the other two animals.

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 skin irritation study was conducted as GLP-study according to OECD no. 404. The test was performed on three NZW rabbits. Slight erythema were observed in all three animals with a mean score of 0.6. These effcts were found to be reversible within 72 hours. Oedema were not seen in all three rabbits. Therefore, the substance can be considered as non-irritant to rabbit skin.