4-(4-isopropoxyphenylsulfonyl)phenol

Endpoint summary

Description of key information

D-8 was tested for skin irritation in rabbits according to EU Test Guideline B.4. No skin irritation was observed in any of the six rabbits. D-8 can be regarded as non-irritant to the skin.

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.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1986-04-17 to 1986-06-11

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system 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;

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 g of test material

Duration of treatment / exposure:

4 hours

Observation period:

4 Days

Number of animals:

six males

Details on study design:

Approximately 24 hours prior to application of the test substance, hair was removed with electric clippers from the dorso-lumbar region of each rabbit exposing an area of skin approximately 10 cm square.
A 0.5 g amount of D-8 was applied under a 2.5 cm square gauze pad moistened with 0.5 mL of distilled water to one intact skin site of each animal.
Each treatment site was occluded with "Elastoplast" elastic adhesive dressing for a four hour period.
The animals were not restrained during the exposure period and were returned to their cages.
At the end of the exposure period, the semi-occlusieve dressing and gauze pad were removed and the treatment site was washed using distilled water to remove any residual test substance.

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

1991

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

1992

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

1993

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #4

Remarks:

1994

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #5

Remarks:

1995

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

animal #6

Remarks:

1996

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

1991

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

1992

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

1993

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #4

Remarks:

1994

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #5

Remarks:

1995

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

animal #6

Remarks:

1996

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

No signs of irritation observed.

Other effects:

No other effects observed.

No dermal irritation was observed in any of the six rabbits.

Interpretation of results:

GHS criteria not met

Conclusions:

D-8 was tested for skin irritation in rabbits according to EU Test Guideline B.4. No skin irritation was observed in any of the six rabbits. D-8 can be regarded as non-irritant to the skin.

Executive summary:

D-8 was tested for skin irritation in rabbits with an occlusive test. The substance was applied on the intact skin for four hours and subsequently removed by rinsing with water. The animals were observed for erythema and oedema on the following 4 days. No signs of dermal irritation was observed in any of the six animals. Therefore, D-8 was considered non-irritant to the skin.

Reference 2

Endpoint:

skin irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro skin irritation study does not need to be conducted because adequate data from an in vivo skin irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

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

Qualifier:

according to guideline

Guideline:

EPA OTS 798.4500 (Acute Eye Irritation)

Deviations:

no

GLP compliance:

yes

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;

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.

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

2

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

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.

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.

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.

Reference 2

Endpoint:

eye irritation: in vitro / ex vivo

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

D-8 was tested for skin irritation in rabbits with an occlusive test. The substance was applied on the intact skin for four hours and subsequently removed by rinsing with water. The animals were observed for erythema and oedema on the following 4 days. No signs of dermal irritation were observed in any of the six animals. Therefore, D-8 was considered non-irritant to the skin.

Eye irritation

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

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008

The available data for skin irritation/corrosion and eye irritation/corrosion are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is neither considered to be classified for skin irritation/corrosion nor for eye irritation/corrosion under Regulation (EC) No 1272/2008, as amended for the twelfth time in Regulation (EU) No 2019/521.