4-methoxybenzyl alcohol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

data is from safety assessment reports

Data source

Reference

Reference Type:

other: Secondary Literature

Title:

SIDS Dossier for the test chemicals

Author:

OECD SIDS

Year:

2010

Bibliographic source:

OECD SIDS, Last updated 2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Fed. Reg. 38, No. 187, § 1500.42

Principles of method if other than guideline:

To assess the ocular irritation potential of the test chemical in rabbits

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Anisaldehyde

EC Number:

204-602-6

EC Name:

Anisaldehyde

Cas Number:

123-11-5

Molecular formula:

C8H8O2

IUPAC Name:

4-Methoxybenzaldehyde

Test material form:

liquid

Details on test material:

- Name of test material (IUPAC name): Benzaldehyde, 4-methoxy-
- Common name: p-Anisaldehyde
- Molecular formula: C8H8O2
- Molecular weight: 136.1492 g/mol
- Smiles notation: COc1ccc(C=O)cc1
- InChl: 1S/C8H8O2/c1-10-8-4-2-7(6-9)3-5-8/h2-6H,1H3
- Substance type: Organic
- Physical State: Liquid (oily liquid)

Test animals / tissue source

Species:

rabbit

Strain:

Vienna White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: male: 3.16 kg; mean of 2 females: 2.46 kg
- Diet (e.g. ad libitum): Ssniff, Intermast

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1ml

Duration of treatment / exposure:

single exposure

Observation period (in vivo):

72 hours

Duration of post- treatment incubation (in vitro):

no data available

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: not performed
SCORING SYSTEM: according to Draize
TOOL USED TO ASSESS SCORE: fluorescein (only at the final reading)

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Remarks:

redness

Basis:

mean

Time point:

24/48/72 h

Score:

0.44

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Reversibility:

fully reversible within: 72 hours

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Moderate discharge was observed 1 h and slight discharge was observed 24 h after application in 3/3 animals. These effects were fully reversible by 72 hours

Any other information on results incl. tables

Eye Irritation Scores

Animal	Reading	Opacity	Cornea area	Iritis	Redness	Chemosis	Discharge
1	1 h	0	0	0	2	1	2
2	1 h	0	0	0	2	1	2
3	1 h	0	0	0	2	2	2
1	24 h	0	0	0	1	0	1
2	24 h	0	0	0	1	0	1
3	24 h	0	0	0	1	0	1
1	48 h	0	0	0	0	0	0
2	48 h	0	0	0	1	0	0
3	48 h	0	0	0	0	0	0
1	72 h	0	0	0	0	0	0
2	72 h	0	0	0	0	0	0
3	72 h	0	0	0	0	0	0
1	24-48-72 h	0	0	0.33	0
2	24-48-72 h	0		0	0.67	0
3	24-48-72 h	0		0	0.33	0
mean	24-48-72 h	0.00		0.00	0.44	0.00

 

Applicant's summary and conclusion

Interpretation of results:

other: not irritating

Conclusions:

Moderate discharge was observed 1 h and slight discharge was observed 24 h after application in 3/3 animals. These effects were fully reversible by 72 hours.
The test substance is considered to be non irritating to the eye. According to the conditions of the test, the test substance does not fullfil the criteria of 67/548/EEC and GHS UN for classification, respectively.

Executive summary:

Acute eye irritation study was carried out to assess the toxicity of the test chemical in rabbits. The study was performed according toFed. Reg. 38, No. 187, § 1500.42 Guidelines.

0.1 ml test chemical was instilled into the eyes of 3 Vienna White rabbits, and the untreated eye served as control. The treated eyes remained unwashed throughout the test. The treated eyes were graded according to Draize scale for opacity corneal, iritis, redness, chemosis, discharge at 24, 48 and 72 hours post instillation.

Moderate discharge was observed 1 h and slight discharge was observed 24 h after application in 3/3 animals. These effects were fully reversible by 72 hours.

The test substance is considered to be non irritating to the eye. According to the conditions of the test, the test substance does not fullfil the criteria of 67/548/EEC and GHS UN for classification, respectively.