4-(4-isopropoxyphenylsulfonyl)phenol

Eye irritation

Administrative data

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-04-24 to 1986-06-12

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1986

Report date:

1986

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

4-(4-isopropoxyphenylsulfonyl)phenol

EC Number:

405-520-5

EC Name:

4-(4-isopropoxyphenylsulfonyl)phenol

Cas Number:

95235-30-6

Molecular formula:

C15H16SO4

IUPAC Name:

4-[4-(propan-2-yloxy)benzenesulfonyl]phenol

Details on test material:

- Name of test material (as cited in study report): D - 8
- Molecular formula: C15 H16 O4 S;
- Molecular weight: 292.4;
- Physical state: white powder;
- Analytical purity: > 99.5 %;
- Purity test date: not stated;
- Lot/batch No.: Not stated;
- Expiration date of the lot/batch: not stated;
- Stability under test conditions: stable at ambient temperature and conditions;
- Storage condition of test material: store in a cool dry place, protected from direct sunlight;

Test animals / tissue source

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Froxfield Rabbits; Petersfield, Hampshire; England;
- Age at study initiation: approximately 11 to 12 weeks;
- Weight at study initiation: 2.4 to 2.7 kg;
- Housing: individually in metal cages with perforated floors;
- Diet: SDS Standard Rabbit Diet ad libitum;
- Water: tap water ad libitum;
- Acclimation period: not stated;

ENVIRONMENTAL CONDITIONS
- Temperature: approximately 19 °C;
- Humidity: 30 - 70 % R.H.;
- Air changes: approximately 19 air changes/min;
- Photoperiod: 12 hours light/12 hours dark;

Test system

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

33 mg occupying a volume of 0.1 mL

Duration of treatment / exposure:

7 days

Observation period (in vivo):

7 days

Number of animals or in vitro replicates:

6 males

Details on study design:

The eyes of each animal were examined prior to instillation of the test substance to ensure that there was no pre-existing corneal damage or conjunctival inflammation.
A 33 mg amount of D-8, the weight occupying a volume of 0.1 mL, was placed into the lower everted lid of one eye of each animal.
The eyelids were then gently hold together for one second before releasing. The contralateral eye remained untreated and served as a control.

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

Results 2

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

Results 3

Irritation parameter:

conjunctivae score

Remarks:

(redness)

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

3

Reversibility:

fully reversible within: 3 days

Results 4

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Instillation of D-8 into the rabbit eye did not elicit a positive response in any of the six treated animals according to the T.S.C.A. test criteria.

Other effects:

No other effects observed.

Any other information on results incl. tables

None of the animals gave a positive response.

No corneal damage or iridial inflammation was observed in any of the animals.

Transient mild conjunctival reactions were seen in five animals.

The eyes were normal two or three days after instillation.

One animal did not show any observable response to treatment throughout the observation period.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

D-8 was tested for eye irritation in rabbits according to the US EPA TSCA guideline 798.4500. Instillation of D-8 into the rabbit eye did not elicit a positive response in any of the six treated animals according to T.S.C.A. test criteria. Therefore, D-8 was considered non-irritant to the rabbit eye.

Executive summary:

D-8 was tested for eye irritation according to test criteria in compliance with the guidelines of the US EPA Toxic Substance Control Act (TSCA). None of the tested animals gave a "positive" response. No corneal damage or iridial inflammation was observed in any of the animals. Transient mild conjunctival reactions were seen in five animals, with eyes normal two or three days after instillation. One animal did not show any observable response to treatment throughout the observation period. Therefore, according to the T.S.C.A. test criteria, D-8 was not considered to cause eye irritation effects.