4-methoxybenzyl alcohol

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:

comparable to guideline study with acceptable restrictions

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: Open Epicutaneous test (OET)

Principles of method if other than guideline:

To determine the highest irritant or non-irritant concentration of the test chemical which is to be used for the 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: 4-methoxybenzyl alcohol
- IUIPAC name: 4-methoxybenzyl alcohol
- Molecular Formula: C8H10O2
- Molecular Weight: 138.166 g/mol
- Substance type: Organic
- Physical state: Liquid
- Purity: 99.9%

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:

positive indication of irritation

Remarks:

3% solution of the substance

Results 2

Irritation parameter:

other: Lowest irritant

Basis:

mean

Time point:

24 h

Reversibility:

not specified

Remarks on result:

positive indication of irritation

Remarks:

10% solution of the substance

Irritant / corrosive response data:

Skin irritation was observed in the test animals at all concentrations after 21 days of repeated application of the test chemical.
The lowest irritant concentration was observed to be 3% test chemical in acetone and highest irritant 10% in test chemical

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:

Skin irritation was observed in the test animals at all concentrations after 21 days of repeated application of the test chemical.
The lowest irritant concentration was observed to be 3% test chemical in acetone and highest irritant 10% in test chemical.
Based on these observations, the test chemical can be considered to be irritating to skin

Executive summary:

A study was performed to determine the highest irritant or non-irritant concentration of the test chemical which is to be used for the  Open Epicutaneous test (OET)

Skin irritation was observed in the test animals at all concentrations after 21 days of repeated application of the test chemical.

The lowest irritant concentration was observed to be 3% test chemical in acetone and highest irritant 10% in test chemical.

Based on these observations, the test chemical can be considered to be irritating to skin