N,N,N',N',N'',N''-hexamethyl-4,4',4''-methylidynetrianiline

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

N,N,N',N',N'',N''-hexamethyl-4,4',4''-methylidynetrianiline

EC Number:

210-043-9

EC Name:

N,N,N',N',N'',N''-hexamethyl-4,4',4''-methylidynetrianiline

Cas Number:

603-48-5

Molecular formula:

C25H31N3

IUPAC Name:

4-{bis[4-(dimethylamino)phenyl]methyl}-N,N-dimethylaniline

Test material form:

solid

Details on test material:

- Purity: not reported

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Gaukler; D-6050 Offenbach/Main, FRG
- Age at study initiation: not reported
- Weight at study initiation: Males (2), 2.83 kg (mean) and Female (1), 2.91 kg (actual)
- Housing: Cage made of stainless steel with wire mesh walk floors, floor area: 40 cm x 51 cm
- Diet: about 130 g per animal per day
- Water: About 250 mL tap water per animal per day
- Acclimation period: At least 8 days before the beginning of the study; same housing conditions as during the study

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24°C
- Humidity (%): 30-70%
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12 hrs light (06:00 to 18:00) and 12 hrs dark (18:00 to 06:00)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

At least 15 hours before the beginning of the study

Vehicle:

water

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 g
- Concentration (if solution): 50% in water

Duration of treatment / exposure:

4 hours

Observation period:

30-60 minutes after removal of the test patch and then 24, 48, and 72 hours after the beginning of the application

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: Test patches were secured in position with a porous dressing (four lavers of absorbent gauze + porous bandage)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Lutrol and Lutrol/water (1:1)
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS: 30-60 minutes and then at 24, 48, and 72 hours after removal of the patch

SCORING SYSTEM: Evaluation of erythema (R) and oedema (ED): 0 =none; 1 = very slight; 2 = well-defined; 3 = moderate to severe; and 4 = severe to very severe; Calculation of the mean according to 83/467/EEC Criteria of July 29, 1983 (For calculation of the means of erythema and oedema only the readings of 24, 48 and 72 hours were used)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 6

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Very slight irritation (score of 1), but no oedema in all 3 rabbits was observed at 30-60 minutes after patch removal. No irritation or oedema was observed 24, 48, and 72 hours.

Any other information on results incl. tables

Results of Acute Skin Irritation/Corrosivity

 

Animal                        1                    2                    3

Sex                  Male               Male               Female

 

Readings	Animal	Erythema	Oedema
4 hours	1 2 3	1 1 1	0 0 0
24 hours	1 2 3	0 0 0	0 0 0
48 hours	1 2 3	0 0 0	0 0 0
72 hours	1 2 3	0 0 0	0 0 0
Mean	1 2 3	0 0 0	0 0 0

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance was not a skin irritant when tested on the skin of rabbits.

Executive summary:

The test substance (0.5 g) dissolved in water was applied to the clipped skin of 3 rabbits and covered for four hours. Erythema and oedema were evaluated at 30-60 minutes after removal of the patch and then at 24, 48, and 72 hours.

Very slight erythema, graded 1 on a scale of 0 to 4, was observed 30-60 minutes after removal of the patch; no oedema was observed. No erythema or oedema was observed at the 24-, 48-, and 72-hour readings.