Sodium anisate

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

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

eye 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

Reason / purpose for cross-reference:

reference to same study

Qualifier:

no guideline followed

Principles of method if other than guideline:

- The test was conducted before guideline was adopted

- Principle of test: the test substance was applied to the left conjunctical sacs of two rabbits, observations were made 1, 24, 48, 72, 96 h as well as 7 days after application

- Parameters analysed / observed: conjunctival chemosis, reddening and swelling, corneal opacity, iritis

GLP compliance:

no

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: single housing
- Diet: typal feeding, ad libitum
- Water: ad libitum

Vehicle:

unchanged (no vehicle)

Remarks:

; the test item was moistened with water before application

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 50 mg

Duration of treatment / exposure:

not applicable as it is not specified whether the treated eyes were rinsed or not

Observation period (in vivo):

7 days
Reading time points: 1, 24, 48, 72 and 96 h and 7 days

Number of animals or in vitro replicates:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: not stated

SCORING SYSTEM:
- scoring was done but the scoring system used for interpretation of the eye reaction was not specified

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

of 2 animals

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Irritation parameter:

iris score

Basis:

mean

Remarks:

of 2 animals

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

of 2 animals

Time point:

24/48/72 h

Score:

0.3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

of 2 animals

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Irritant / corrosive response data:

A grade 1 conjunctivae redness was noted 1 h after instillation in both animals. At the 24 h reading time point, the conjunctivae redness graded 1 was still present in one animal, whereas in the second, the finding seems to become weaker, as based on the grading reported as (1). After 48 hours, no more conjunctivae redness was seen for both animals, indicating complete reversibility. No further effects were noticed.

Table 1: In Vivo Eye Irritation Scores

Animal No.	Irritation parameter	Reading times
		1h	24 h	48 h	72 h	96 h	7 days
21	cornea	0	0	0	0	0	0
	iris	0	0	0	0	0	0
	conjunctiva	1	1	0	0	0	0
	chemosis	0	0	0	0	0	0
	lacrimation	0	0	0	0	0	0
22	cornea	0	0	0	0	0	0
	iris	0	0	0	0	0	0
	conjunctiva	1	(1)	0	0	0	0
	chemosis	1	0	0	0	0	0
	lacrimation	0	0	0	0	0	0

 

Interpretation of results:

GHS criteria not met

Conclusions:

In a reliable study, that was conducted prior to implementation of the current guidelines, the eye irritation potential of p-anisic acid was tested in two rabbits. Eye reactions were restricted to conjunctivae redness which disappeared within 48 h. It was concluded that under the test conditions used, the p-anisic acid was slightly and transiently irritant to the eye, but the obtained results do not warrant any classification as irritant to the eye.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

- The test was conducted before guideline was adopted.

- Principle of test: the test substance was applied to one auricle (inner surface) of each of 2 rabbits under semi-occlusive conditions for 24 hours. After the exposition remaining test item was removed by washing. Observations were made at removal of test item, after 24, 48 and 72 h as well as 7 days after application

- Parameters analysed / observed: erythema, edema and eschar formation

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

p-anisic acid

EC Number:

202-818-5

EC Name:

p-anisic acid

Cas Number:

100-09-4

Molecular formula:

C8H8O3

IUPAC Name:

4-methoxybenzoic acid

Test material form:

solid

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 3-4 kg
- Housing: single housing
- Diet: typal feeding, ad libitum
- Water: ad libitum

Test system

Type of coverage:

semiocclusive

Preparation of test site:

not specified

Vehicle:

unchanged (no vehicle)

Remarks:

; the test item was moistened with water before application

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 500 mg

Duration of treatment / exposure:

24 h

Observation period:

7 days
Reading time points: after washing, 24, 48 and 72 h and 7 days

Number of animals:

2

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: with water and soap
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
- after washing, 24, 48 and 72 h and 7 days

SCORING SYSTEM:
- the scoring system used for interpretation of the skin reaction was not specified

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Remarks:

of 2 animals

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Remarks:

of 2 animals

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Results 3

Irritation parameter:

other: eschar formation

Basis:

mean

Remarks:

of 2 animals

Time point:

24/48/72 h

Score:

0

Reversibility:

other: not applicable

Irritant / corrosive response data:

At none of the reading time points, reactions indicative of skin irritation were noticed.

Other effects:

- Adverse systemic effects: no systemic effects were reported.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

In a reliable study, that was conducted prior to implementation of the current guidelines, the skin irritation potential of p-anisic acid was tested by semiocclusive application of the test substance to rabbit ears for 24 h. No skin reaction was noted at any reading time point thus under the conditions of the test the compound was not a skin irritant.