3,4-dimethoxyphenethylamine

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Justification for type of information:

data is from experimental reports

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: as mentioned below

Principles of method if other than guideline:

The skin irritation potential of 4-methoxybenzyl alcohol / Anisic alcohol (CAS No: 105-13-5) was assessed in guinea pigs via Open Epicutaneous test (OET).

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

4-methoxybenzyl alcohol

EC Number:

203-273-6

EC Name:

4-methoxybenzyl alcohol

Cas Number:

105-13-5

Molecular formula:

C8-H10-O2

IUPAC Name:

(4-methoxyphenyl)methanol

Test material form:

liquid

Details on test material:

- Name of test material (as cited in study report): 4-methoxybenzyl alcohol
-Molecular Formula: C8H10O2
- Molecular Weight: 138.165 g/mol
- Substance type: Organic
- Physical state: Liquid

Specific details on test material used for the study:

- Name of test material (as cited in study report): 4-methoxybenzyl alcohol
-Molecular Formula: C8H10O2
- Molecular Weight: 138.165 g/mol
- Substance type: Organic
- Physical state: Liquid

Test animals

Species:

guinea pig

Strain:

not specified

Test system

Type of coverage:

open

Preparation of test site:

other: clipped flank

Vehicle:

other: acetone

Controls:

yes

Amount / concentration applied:

60, 30, 10 and 3 %

Duration of treatment / exposure:

21 days

Observation period:

after a single application or after repeated application over 21 successive days

Number of animals:

6-8

Details on study design:

One day before starting the induction procedure, the threshold-toxic concentration of the test material is estimated. A single application of 0.025 ml of each test concentration (e.g. 100, 30, 10 and 3%) is simultaneously performed on one of the areas measuring 2cm2 of the flank skin previously clipped and marked with a circular stamp.
The skin reactions are read 24 hours after the application of the test material. The minimal irritant and the maximal non-irritant concentrations are determined by an all-or-none criterion. The minimal irritant concentration is defined as the lowest one causing skin irritation. The maximal non-irritant concentration is defined as the highest one not causing macroscopic skin reactions in any of the animals. The estimation of the threshold concentration (minimal irritating and maximal non-irritating concentrations) is essential for the evaluation of the allergenic capacity of the test material based on the end point determination.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

other: Highest non irritant

Basis:

mean

Time point:

24 h

Reversibility:

not specified

Remarks on result:

other: 3% solution of the substance

Results 2

Irritation parameter:

other: Lowest irritant

Basis:

mean

Time point:

other: 24 hr

Reversibility:

not specified

Remarks on result:

other: 10% solution of the substance

Results 3

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: day 7, 14 and 21

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Irritant / corrosive response data:

slight irritation was observed.

Any other information on results incl. tables

After repeated application over 21 successive days

Concentration %	Skin irritation after days
	7	14	21
60	(+)	+	+
30	(+)	+	+
10	(+)	(+)	(+)
3	-	(+)	(+)

Degree of skin irritation:

- = none

(+) = very slight

+ = slight

++ = moderate

+++ = strong

++++ = very strong

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

A single application of Anisyl alcohol (4-methoxybenzyl alcohol) 3% in acetone is well tolerated. Repeated applications cause very slight skin irritation only. The highest concentration of the preparation used for this treatment was 60%. Hence the chemical 4-methoxybenzyl alcohol / Anisic alcohol (CAS No: 105-13-5) was considered as irritating to the skin og guinea pigs.

Executive summary:

The skin irritation potential of 4-methoxybenzyl alcohol / Anisic alcohol (CAS No: 105-13-5) was assessed in guinea pigs via Open Epicutaneous test (OET).

The 0.025ml of chemical was applied at different concentrations (60, 30, 10 and 3 %) to an area measuring 2cm²previously marked with a circular stamp on the clipped flanks in of 6 to 8 animals under non-occlusive condition.

Skin reactions were evaluated after 24 hours of application and on day 7, 14 and 21.

A single application of Anisyl alcohol (4-methoxybenzyl alcohol) 3% in acetone is well tolerated. Repeated applications cause very slight skin irritation only. The highest concentration of the preparation used for this treatment was 60%.

Hence the chemical 4-methoxybenzyl alcohol / Anisic alcohol (CAS No: 105-13-5) was considered as irritating to the skin on guinea pigs.