Tetrapropylammonium bromide

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

May 1986

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study was performed in accordance with current OECD guideline and is well documented.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted 12 May 1981

GLP compliance:

no

Remarks:

Study performed before GLP guidelines were in place.

Test material

Test material information

Constituent 1

Reference substance name:

Tetrapropylammonium bromide

EC Number:

217-727-6

EC Name:

Tetrapropylammonium bromide

Cas Number:

1941-30-6

Molecular formula:

C12H28N.Br

IUPAC Name:

tetrapropylazanium bromide

Details on test material:

- Name of test material: TPAB
- Chemical name: Tetra-n-propylammonium bromide
- CAS no.: 1941-30-6
- Substance type: hygroscopic crystalline powder
- Solubility: water, ethanol
- Melting point: 260-270°C
- Storage condition of test material: at ambient temperature in the dark

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: The Broekman Institute, Someren, The Netherlands
- Age at study initiation: 3 to 4 months
- Weight at study initiation: 2608 - 2839 g
- Housing: individually housed
- Diet: 100 g standard laboratory animal diet (Hope Farms, Woerden (LK-01, pellet diameter 4 mm)) per day
- Water: ad libitum, tap water
- Acclimation period: > 4 weeks

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-21
- Humidity (%):60-70
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 11-03-1986 To: 14-03-1986

Test system

Type of coverage:

semiocclusive

Preparation of test site:

other: fur was clipped on day before exposure

Vehicle:

water

Remarks:

0.5 ml Milli-RO water

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: appr. 6cm2
- Type of wrap if used: substance was spread on a patch of Metalline (Lohmann, FRG), mounted on permeable tape (Micropore, 3M,ST. Paul, USA)and fixed with flexible bandage (Coban, 3M, St. Paul, USA),

REMOVAL OF TEST SUBSTANCE
- Washing: yes, with a tissue moistened with tap-water
- Time after start of exposure: 4 hours

SCORING SYSTEM: Numerical scoring as described in the OECD guideline, at 1 hr, 24, 48 and 72 hours after removal of the dressing

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of three animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of three animals

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Irritant / corrosive response data:

No test substance related effects were observed.

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

An acute dermal Irritation test was performed according to OECD guideline 404. No substance related effects were seen. Therefore, TPAB can be classified as non-irritant to the skin, according to Regulation (EC) No. 1272/2008.

Executive summary:

An acute dermal Irritation test was performed according to OECD guideline 404. No substance related effects were seen. Therefore, TPAB can be classified as non-irritant to the skin, according to Regulation (EC) No. 1272/2008.