4-Nitrophenyl 2-(methylsulphonyl)ethanoate

Endpoint summary

Description of key information

Skin irritation / corrosion:

In vivo skin irritation, key study:

The study was performed to assess the irritancy potential of the test item following a single, 3-Minute, 1 and 4-Hour, semi-occluded application to the intact rabbit skin according to OECD 404.

The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme.

Eye irritation:

In vivo eye irritation, key study:

The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit according to OECD 405.

The test item produced a maximum group mean score of  15.7 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2014-04-30 to 2014-05-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

24 April 2002

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch No.: PNP-0020313
Purity: 99.5%

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: supplied by Harlan Laboratories UK Ltd.
- Age at study initiation: twelve to twenty weeks
- Weight at study initiation: 2.50 to 2.89 kg
- Housing: individually housed in suspended cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 g of the test item moistened sufficiently with 0.5 mL of distilled water

Duration of treatment / exposure:

Animal 1: 3 minutes, 1 hour and 4 hours
Animal 2&3: 4 hours

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 cm x 2.5 cm
- Type of wrap if used: the trunk of the rabbit was wrapped in an elasticated corset

REMOVAL OF TEST SUBSTANCE
- Washing: any residual test item removed by gentle swabbing with cotton wool soaked in distilled water.
- Time after start of exposure: Animal 1: 3 minutes, 1 hour and 4 hours after application; Animal 2&3: 4 hours after application

OBSERVATION TIME POINTS
Immediately following removal of the patches and approximately 1, 24, 48 and 72 hours later

SCORING SYSTEM:
- Method of calculation: Draize

Irritation parameter:

edema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: 4-hour exposure

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: 4-hour exposure

Irritation parameter:

edema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: For 3-minute, 1-hour and 4-hour exposures

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: 4-hour exposure

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: 4-hour exposure

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Remarks on result:

other: For 3-minute, 1-hour and 4-hour exposures

Irritant / corrosive response data:

No evidence of skin irritation was noted for 3-minute, 1-hour and 4-hour exposures.
No corrosive effects were noted.

Other effects:

All animals showed expected gain in body weight during the study.

Individual Skin Reactions Following 4-Hour Exposure:

Animal No.	Erythema score			Edema score
	24 h	48 h	72 h	24 h	48 h	72 h
1	0	0	0	0	0	0
2	0	0	0	0	0	0
3	0	0	0	0	0	0

Interpretation of results:

GHS criteria not met

Conclusions:

The test item produced a primary irritation index of 0.0 and was classified as non-irritant to
rabbit skin according to the Draize classification scheme.

Executive summary:

The study was performed to assess the irritancy potential of the test item following a single, 3-Minute, 1 and 4-Hour, semi-occluded application to the intact rabbit skin according to OECD 404.

3-Minute and 1-Hour semi-occluded applications of the test item to the intact skin of one rabbit produced no evidence of skin irritation.
A single 4-Hour, semi-occluded application of the test item to the intact skin of three rabbits produced no evidence of skin irritation.

The test item produced a primary irritation index of 0.0 and was classified as non-irritant to rabbit skin according to the Draize classification scheme.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 2014-05-15 to 2014-06-01

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Version / remarks:

02 October 2012

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

Batch No.: PNP-0020313
Purity: 99.5%

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: supplied by Harlan Laboratories UK Ltd.
- Age at study initiation: twelve to twenty weeks old
- Weight at study initiation: 2.35 to 2.77 kg
- Housing: individually housed in suspended cages
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least five days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17 to 23 °C
- Humidity (%): 30 to 70%
- Air changes (per hr): at least fifteen changes per hour
- Photoperiod (hrs dark / hrs light): twelve hours continuous light (06:00 to 18:00) and twelve hours darkness

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.1 mL (approximately 80 mg)

Observation period (in vivo):

72 h

Number of animals or in vitro replicates:

3 males

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: no

SCORING SYSTEM: Draize


TOOL USED TO ASSESS SCORE: ophthalmoscope

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48 h

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 72 h

Irritation parameter:

conjunctivae score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0.33

Max. score:

2

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.67

Max. score:

2

Reversibility:

fully reversible within: 48 h

Irritation parameter:

conjunctivae score

Basis:

animal #1

Time point:

24/48/72 h

Score:

1

Max. score:

2

Reversibility:

fully reversible within: 72 h

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24 h

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

1

Reversibility:

fully reversible within: 24h

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.33

Max. score:

1

Reversibility:

fully reversible within: 48h

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

No corneal effects were noted during the study.
Iridial inflammation was noted in all treated eyes 1 hour after treatment and in one treated eye at the 24-Hour observation.
Moderate conjunctival irritation was noted in all treated eyes 1 and 24 hours after treatment. Minimal conjunctival irritation was noted in one treated eye treated eye at the 48-Hour observation.
Two treated eyes appeared normal at the 48-Hour observation and one treated eye appeared normal at the 72-Hour observation.

Other effects:

Yellow colored staining of the fur around the treated eye was noted in all animals during the study.
All animals showed expected gain in body weight during the study.

Individual Scores for Ocular Irritation:

Animal No.	Cornea opacity			Iris			Conjunctivae redness			Chemosis
	24 h	48 h	72 h	24 h	48 h	72 h	24 h	48 h	72 h	24 h	48 h	72 h
1	0	0	0	1	0	0	2	1	0	1	1	0
2	0	0	0	0	0	0	2	0	0	1	0	0
3	0	0	0	0	0	0	1	0	0	1	0	0

Interpretation of results:

GHS criteria not met

Conclusions:

The test item produced a maximum group mean score of 15.7 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

Executive summary:

The study was performed to assess the irritancy potential of the test item to the eye of the New Zealand White rabbit according to OECD 405.

A single application of the test item to the non-irrigated eye of three rabbits produced iridial inflammation and moderate conjunctival irritation. Two treated eyes appeared normal at the 48-Hour observation and one treated eye appeared normal at the 72-Hour observation.

The test item produced a maximum group mean score of  15.7 and was classified as a mild irritant (Class 4 on a 1 to 8 scale) to the rabbit eye according to a modified Kay and Calandra classification system.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Skin irritation / corrosion:

In vivo skin irritation, key study, OECD 404:

Mean score for erythema at 24, 48, 72 h for 3 tested animal after 4-hour exposure: 0, 0, 0

Mean score for edema at 24, 48, 72 h for 3 tested animal after 4-hour exposure: 0, 0, 0

According to Regulation (EC) No 1272/2008, table 3.2.2, this substance should not be classified for this endpoint.

 

Eye irritation:

In vivo eye irritation, key study, OECD 405:

Mean scores for cornea opacity, iris, conjunctivae and chemosis at 24, 48, and 72h:

cornea opacity: 0, 0, 0;

iris: 0.33, 0, 0;

conjunctivae: 1, 0.67, 0.33;

chemosis: 0.67, 0.33, 0.33.

According to Regulation (EC) No 1272/2008, table 3.3.2, this substance should not be classified for this endpoint.