4-aminomethyl-2-methoxyphenol hydrochloride

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2000-10-23 to 2000-11-02

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

(17 July, 1992)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Version / remarks:

(1992)

Test guideline 3

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2500 (Acute Dermal Irritation)

Version / remarks:

(June 1996)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

4-aminomethyl-2-methoxyphenol hydrochloride

EC Number:

230-468-3

EC Name:

4-aminomethyl-2-methoxyphenol hydrochloride

Cas Number:

7149-10-2

Molecular formula:

C8H11NO2.ClH

IUPAC Name:

4-aminomethyl-2-methoxyphenol hydrochloride

Test material form:

other: solid

Details on test material:

- Physical state: white solid
- Analytical purity: 99.77 %(w/w)
- Lot/batch No.: 77

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Winkelmann GmbH, D-33178 Borchen
- Weight at study initiation: 3.7 - 4.0 kg
- Housing: housed in ABS - plastic rabbit cages, floor 4200 cm2
- Diet: free access to Altromin 2123 maintenance diet for rabbits, rich in crude fiber, totally pathogene free-TPF
- Water: free access to tap water (drinking water, municipal residue control, microbiol. controlled periodically)
- Acclimation period: adequate

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 +/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): at least 10 x
- Photoperiod (hrs dark / hrs light): 12 : 12, light 6.30 - 18.30

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Remarks:

Approximately 24h before the test, fur was removed from the dorsal area of the trunk.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g to each site

Duration of treatment / exposure:

4 h

Observation period:

examined for signs of erythema and oedema at 1, 24, 48 and 72 h after patch removal

Number of animals:

3 female

Details on study design:

TEST SITE
- Area of exposure: approx. 6 cm2, dorsal skin of rabbit
- Type of wrap: gauze patch, non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: residual test item removed by using water
- Time after start of exposure: 4 h (end of exposure)

OBSERVATION TIME POINTS
1, 24, 48 and 72 h after patch removalTEST SITE
- Area of exposure: approx. 6 cm2, dorsal skin of rabbit
- Type of wrap: gauze patch, non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing: residual test item removed by using water
- Time after start of exposure: 4 h (end of exposure)

OBSERVATION TIME POINTS
1, 24, 48 and 72 h after patch removal

SCORING SYSTEM:
- Method of calculation: according to guideline OECD 404

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: all animals

Time point:

other: 1, 24, 48 and 72 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

animal: all animals

Time point:

other: 1, 24, 48 and 72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

The test item showed no irritant effects on the intact skin after a contact time of 4 hours.

Other effects:

no

Any other information on results incl. tables

	1 hour		24 hours		48 hours		72 hours
Animal No.	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema
305
Test Item	0	0	0	0	0	0	0	0
Control	0	0	0	0	0	0	0	0
306
Test Item	0	0	0	0	0	0	0	0
Control	0	0	0	0	0	0	0	0
339
Test Item	0	0	0	0	0	0	0	0
Control	0	0	0	0	0	0	0	0

Irritation of the test item to the test animals: 0: no erythema/no oedema

Applicant's summary and conclusion

Interpretation of results:

other: "not classified" according CLP

Conclusions:

Considering the reported data of this irritation study it can be stated that the test item Vanillylamin-HCl showed no irritant/corrosive effects.

Executive summary:

In this irritation study the test item Vanillylamin-HCl was applied to one site of the closely clipped backs of 3 rabbits (strain NZW) at a dose of 0.5 g per application site. The untreated other site served as a control.

The application site was covered with a semi - occlusive bandage for a 4 hour - contact time.

Observations were revorded and compared to the control sites, 1 h, 24 h, 48 h and 72 hours after removal of the dressing.

The test item Vanillylamin-HCl showed no irritant effects on the intact skin after a contact time of 4 hours.

No other clinical signs of toxicity were found.

Considering the reported data of this irritation study it can be stated that the test item Vanillylamin-HCl showed no irritant/corrosive effects.