3-diazo-3,4-dihydro-4-oxonaphthalene-1-sulfonyl chloride

Endpoint summary

Description of key information

The test item is not considered to be irritating to skin as determined in a study according to OECD Guideline 404.

The test item is considered to be irritating to eyes as determined in a study according ti OECD Guideline 405.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

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

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-04-12 to 1988-04-22

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)

Version / remarks:

04-1984

Deviations:

no

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

05-1981

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.8 - 3.3 kg
- Housing: single
Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

other: PEG 400

Controls:

no

Amount / concentration applied:

500 mg moistened with 0.6 mL PEG 400

Duration of treatment / exposure:

4 h

Observation period:

Up to 7 days

Number of animals:

3

Details on study design:

On the day before the test each of a group of three rabbits was clipped free of fur from the dorsal/flank area. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. A quantity of 500 mg of the test material was introduced under a 2.5 * 2.5 cm gauze patch and placed in position. The patch was secured in position with a strip of surgical adhesive tape.
Four hours after application the patches were removed from each animal and any residual test material removed with tap water.
Approximately 30-60 min following the removal of the patches, and 24, 48 and 72 hours and 7 days later, the test sites were examined for evidence of primary irritation.

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.4

Max. score:

4

Reversibility:

fully reversible within: 7 days

Remarks on result:

no indication of irritation

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible within: 24 hrs

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The observed effects were fully reversible within 7 days

Study design

The purpose of this GLP study performed according to OECD GL 404 was to assess the irritancy potential of the test item to the skin of the New Zealand White rabbits.

Results

The application of the test material to the intact skin produced no significant irritation.

Conclusion

The test material gave no indication for skin irritation in rabbits.

Interpretation of results:

GHS criteria not met

Conclusions:

The test material gave no indication for skin irritation in rabbits.

Executive summary:

This study was performed according to GLP and is fully compliant with OECD GL 404. Based on the results of this study it was concluded that the test item is not irritant to the skin of rabbits.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Reference 1

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

Reference 2

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1988-04-19 to 1988-04-26

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:

02-1987

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Version / remarks:

04-1984

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Hoechst AG, Kastengrund, Germany
- Age at study initiation: 3 - 5 months
- Weight at study initiation: 2.4 - 3 kg
- Housing: single
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3
- Humidity (%): 50 +/- 20
- Photoperiod (hrs dark / hrs light): 12 / 12

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

100 mg

Duration of treatment / exposure:

single application

Observation period (in vivo):

up to 72 hrs

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
-Washing: no

SCORING SYSTEM: according to OECD Guideline

TOOL USED TO ASSESS SCORE: fluorescein

Irritation parameter:

cornea opacity score

Basis:

mean

Time point:

24/48/72 h

Score:

0.2

Max. score:

4

Reversibility:

fully reversible within: 2 days

Remarks on result:

positive indication of irritation

Irritation parameter:

iris score

Basis:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

2

Reversibility:

fully reversible within: 2 days

Remarks on result:

positive indication of irritation

Irritation parameter:

conjunctivae score

Basis:

mean

Time point:

24/48/72 h

Score:

2.6

Max. score:

3

Reversibility:

fully reversible within: 7 days

Remarks on result:

positive indication of irritation

Irritation parameter:

chemosis score

Basis:

mean

Time point:

24/48/72 h

Score:

1.9

Max. score:

4

Reversibility:

fully reversible within: 7 days

Study design

The purpose of this GLP study performed according to OECD GL 405 was to assess the eye irritancy potential of the test item in New Zealand White rabbits.

Results

The application of the test material caused an eye irritation. The observed effects were reversible within 7 days after application.

Conclusion

Based on the obtained results the test item can be classified as eye irritant.

Interpretation of results:

Category 2B (mildly irritating to eyes) based on GHS criteria

Conclusions:

The application of the test material caused an eye irritation. The observed effects were reversible within 7 days after application.

Executive summary:

This study was performed according to GLP and is fully compliant with OECD GL 405. The application of the test material caused an eye irritation in rabbits and the observed effects were reversible within 7 days after application. Therefore, the test item can be classified as eye irritant.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Justification for classification or non-classification

Based on the provided information there is no need for classification forskin irritationaccording to the EU Regulation (EC) No 1272/2008 on Classification, Labelling and Packaging of Substances and Mixtures, as amended for the 10th time in Regulation (EU) No 2017/776.

Based on the provided information the test item is classified for eye irritation category 2 and labelled with H319 according to the EU Regulation (EC) No 1272/2008 on Classification,Lab elling and Packaging of Substances and Mixtures, as amended for the 10th time in Regulation (EU) No 2017/776. In accordance with UN GHS Rev. 7 (2017), the test item is considered midly irritating to eyes (Category 2B).