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Toxicological information

Eye irritation

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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

Constituent 1
Chemical structure
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

Resultsopen allclose all
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
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
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
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).

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