Sodium 4-(methoxycarbonyl)phenolate

Eye irritation

Administrative data

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:

other: Guideline study with acceptable restrictions. Not performed according to GLP. No analytical purity.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1981

Report date:

1981

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulations, Title 16, Section 1500.42

Deviations:

no

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 4-(methoxycarbonyl)phenolate

EC Number:

225-714-1

EC Name:

Sodium 4-(methoxycarbonyl)phenolate

Cas Number:

5026-62-0

Molecular formula:

C8H8O3.Na

IUPAC Name:

methyl 4-hydroxybenzoate

Details on test material:

- Name of test material (as cited in study report): Solbrol M Na-Salz
- Physical state: solid
- Analytical purity: no data

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Lippische Versuchstierzucht, Extertal, Germany
- Weight at study initiation: average of 2.1 kg
- Housing: Animals were housed individually.
- Diet: mümmel z, ssniff, Soest, Germany, ad libitum
- Water: ad libitum
- Acclimation period: 7 - 14 d

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16 - 18
- Humidity (%): 40
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Vehicle:

unchanged (no vehicle)

Controls:

other: Not required, the untreated eye of each animal served as control.

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 100 µL (bulk volume)

Duration of treatment / exposure:

single application without washing

Observation period (in vivo):

8 d
reading time points: 24, 48 and 72 h

Number of animals or in vitro replicates:

6 males

Details on study design:

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0.89

Max. score:

4

Reversibility:

not fully reversible within: 8 d in 2 animals

Remarks on result:

other: fully reversible in 2 animals each within 48 h and 72 h, respectively

Results 2

Irritation parameter:

iris score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

0.83

Max. score:

2

Reversibility:

not fully reversible within: 8 d in 3 animals

Remarks on result:

other: fully reversible within 48 h in 2 animals and within 8 d in 1 animal

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

2.17

Max. score:

3

Reversibility:

not fully reversible within: 8 d in 3 animals

Remarks on result:

other: fully reversible within 8 d in 3 animals

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Remarks:

out of all 6 animals

Time point:

24/48/72 h

Score:

1.33

Max. score:

4

Reversibility:

not fully reversible within: 8 d in 2 animals

Remarks on result:

other: fully reversible within 8 d in 4 animals

Any other information on results incl. tables

Table 1. Results of eye irritation study.

Rabbit #	Time	conjunctivae		iris	cornea
		redness	swelling
1	24 h	2	1	1	2
	48 h	2	1	1	2
	72 h	2	1	1	1
	8 d	1	0	1	1
	average	2,0	1,0	1,0	1,7
2	24 h	2	1	0	1
	48 h	2	1	1	0
	72 h	2	1	1	0
	8 d	0	0	0	0
	average	2,0	1,0	0,7	0,3
3	24 h	2	1	1	1
	48 h	2	1	1	1
	72 h	2	1	1	0
	8 d	2	1	1	0
	average	2,0	1,0	1,0	0,7
4	24 h	2	1	1	1
	48 h	2	1	1	1
	72 h	2	1	0	0
	8 d	0	0	0	0
	average	2,0	1,0	0,7	0,7
5	24 h	2	1	1	1
	48 h	2	1	1	0
	72 h	2	1	0	0
	8 d	0	0	0	0
	average	2,0	1,0	0,7	0,3
6	24 h	3	3	1	1
	48 h	3	3	1	2
	72 h	3	3	1	2
	8 d	1	1	1	1
	average	3,0	3,0	1,0	1,7
	Time	conjunctivae		iris	cornea
		redness	swelling
	24 h	2,17	1,33	0,83	1,17
	48 h	2,17	1,33	1,00	1,00
	72 h	2,17	1,33	0,67	0,50
	24+48+72	2,17	1,33	0,83	0,89

After the 8 d-observation period, the effects on cornea and the swelling of conjunctivae were not fully reversible in 2 animals and the effects on iris and the redness of the conjunctivae were not fully reversible in 3 animals.

Applicant's summary and conclusion

Interpretation of results:

corrosive

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

CLP: Eye dam. 1, H318
DSD: Xi, R41

Executive summary:

he eye irritating potential of sodium methyl-4-hydroxybenzoate was investigated in a study performed by Schreiber (1981b) according to the Code of Federal Regulations, Title 16, Section 1500.42. 0.1 mL of the unchanged test substance was instilled in one eye of each of 6 male New Zealand White rabbits without washing afterwards. The second eye of each animal was left untreated and served as control. The grades of ocular reaction (conjunctivae redness, conjunctivae chemosis, cornea, iris) were assessed 24, 48 and 72 h and 8 d after instillation of the test substance.

At 24 h post-application, swelling (score 1-3) and redness (score 2-3) of the conjunctivae were observed in all animals. The effects on conjunctivae persisted during the 48 and 72 h reading time point in all animals. After 8 d, the conjunctivae redness had fully reversed in 3/6 animals and the swelling of conjunctivae had fully reversed in 4/6 animals. Redness of the conjunctivae (score 1-2) was still noted in 3/6 rabbits and 2/6 rabbits still showed conjunctivae swelling (score 1). At 24 h post-application, effects on the iris (score 1) were observed in 5/6 rabbits. At the 48 h reading time point, the iris irritation (score 1) was noted in all animals. After 72 h, the effect persisted in 4/6 animals and reversed in 2/6 animals. After 8 d, the iris irritation had resolved in 3/6 animals. In all other rabbits the iris irritation still persisted. Corneal opacity (score 1-2) was noted in all rabbits after 24 h. The observation reversed in 2/6 animals within 48 h and in 2/6 other animals within 72 h. After 8 d, corneal opacity (score 1) was still noted in 2/6 animals.

Under the test conditions, the test substance was corrosive to the eyes (Category 1).