N,N,N',N'-tetramethyltrimethylenediamine

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:

other: Comparable to guideline study with acceptable restrictions (occlusive treatment)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(limited documentation, occlusive treatment)

Principles of method if other than guideline:

Method: BASF-Test
Three animals were treated for 3 min and 1 h using occlusive conditions. The application site of 2.5 x 2.5 cm (flanks) was covered with the liquid test substance. After exposure the skin was washed with Lutrol (conc.) and Lutrol/water (1:1). The animals were observed for 8 days and skin changes were recorded after patch removal, 24 h, 48 h and 8 days after application. The test is comparable to the initial test descirbed in the OECD guideline 404 to evaluate the corrosive potential of a test substance.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

N,N,N',N'-tetramethyltrimethylenediamine

EC Number:

203-818-8

EC Name:

N,N,N',N'-tetramethyltrimethylenediamine

Cas Number:

110-95-2

Molecular formula:

C7H18N2

IUPAC Name:

N,N,N',N'-tetramethyltrimethylenediamine

Details on test material:

- Name of test material (as cited in study report): Tetramethylpropandiamin-1,3
- Analytical purity: 99%
- Physical state: liquid

Test animals

Species:

rabbit

Strain:

Vienna White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Firma Gaukler; Offenbach Germany
- Weight at study initiation: 3.07 kg (mean)
- Housing: one per cage
- Diet: Ovator Solikanin 4 mm; Muskator-Werke Duesseldorf; ad libitum
- Water: FulIy demineralized water ad libitum each workday; tap water ad libitum on public holidays.
- Acclimation period: ca. 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-26 °C
- Humidity (%): 30-70 %
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

other: clipped

Vehicle:

unchanged (no vehicle)

Controls:

other: untreated skin served as control

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ca. 0.5 mL

Duration of treatment / exposure:

3 min (right flank) and 1 h (left flank)

Observation period:

8 days

Number of animals:

1 male and 2 females

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm


REMOVAL OF TEST SUBSTANCE
- Washing (if done): with Lutrol (conc.) and Lutrol/water (1:1)
- Time after start of exposure: 3 min or 1 h

EVALUATION: according to the Draize Scoring System

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: corrosion

Basis:

mean

Remarks:

(3 animals, 3 min exposure)

Remarks on result:

other: Non-reversible necroses (superficial) were observed in all animals.

Results 2

Irritation parameter:

other: corrosion

Basis:

mean

Remarks:

(3 animals, 1 h exposure)

Remarks on result:

other: Non-reversible, full thickness necroses were observed in all animals.

Results 3

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(3 min exposure)

Time point:

other: 24 h - 48 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(3 min exposure)

Time point:

other: 24 h - 48 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 5

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(3 min exposure)

Time point:

other: 24 h - 48 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 6

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

(1 h exposure)

Time point:

other: 24 h - 48 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 7

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

(1 h exposure)

Time point:

other: 24 h - 48 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 8

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

(1 h exposure)

Time point:

other: 24 h - 48 h

Score:

4

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 9

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(3 min exposure)

Time point:

other: 24 h - 48 h

Score:

3

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 10

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(3 min exposure)

Time point:

other: 24 h - 48 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 11

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(3 min exposure)

Time point:

other: 24 h - 48 h

Score:

2

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 12

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

(1 h exposure)

Time point:

other: 24 h - 48 h

Score:

3.5

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 13

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

(1 h exposure)

Time point:

other: 24 h - 48 h

Score:

3.5

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Results 14

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

(1 h exposure)

Time point:

other: 24 h - 48 h

Score:

3.5

Max. score:

4

Reversibility:

not fully reversible within: 8 days

Applicant's summary and conclusion

Interpretation of results:

Category 1B (corrosive)

Remarks:

Migrated information Criteria used for interpretation of results: EU