Sodium 4-hydroxyphenylglycolate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 26 February 1984 to 18 June 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

HF 7945

IUPAC Name:

HF 7945

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals / tissue source

Species:

rabbit

Strain:

other: New Zealand Hy/Cr

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Centre d'élevage Charles River France (76410 Saint Aubin les Elbeuf)
- Age at study initiation: -
- Weight at study initiation: 2.43 kg ± 0.08 kg
- Housing: individually in polystyrene cages (0.32 x 0.35 x 0.55 m)
- Diet: Rabbit diet SQC, ad libitum
- Water: filtered water (Millipore membrane 0.22µm)
- Acclimation period: 9 days

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 3°C
- Humidity: 50 ± 20 %
- Air changes: -
- Photoperiod: 12 hrs dark / 12 hrs light

IN-LIFE DATES: -

Test system

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 100 mg
- Concentration: undiluted

Duration of treatment / exposure:

one instillation (not rinsed)

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

6

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: according to OECD guideline

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Remarks on result:

no indication of irritation

Results 3

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

0.33

Max. score:

3

Reversibility:

fully reversible within: 72 hours

Remarks on result:

other: see details below

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

For cornea, iris and conjunctival chemosis, all scores in all animals are equal to 0 (no effect).
For conjuntivae redness, some effects were observed at 24 and 48 hours after treatment: at 24 and 48 hours, 3/6 animals have a score of 1 (other scores are equal to 0).

Any other information on results incl. tables

Table : Scores in the 6 animals at 1, 24, 48 and 72 hours

	1 hour	24 hours	48 hours	72 hours
Chemosis	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0
Conjunctivae	0/0/0/0/0/0	1/1/0/0/0/1	1/1/0/0/0/1	0/0/0/0/0/0
Iris	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0
Cornea	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0	0/0/0/0/0/0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

HF 7645 is not irritating to the eye.

Executive summary:

HF 7645 was tested for eye irritation / corrosion in rabbits according to OECD guideline n°405 and Good Laboratory Practice.

All scores are equal to 0, except for conjunctival redness where 3/6 rabbits have a score of 1 at 24 and 48 hours.

According to the results of this test, HF 7645 is not considered as irritating to the eye.