Registration Dossier

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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of three animals
Time point:
other: 24, 48 and 72 hours
Score:
0
Max. score:
4
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.