Benzenesulfonamide, N-[2-[[(phenylamino)carbonyl]amino]phenyl]-

Endpoint summary

Description of key information

In a GLP-study according to OECD TG 429 (Local Lymph Node Assay), the substance did not induce any adverse effects and is therefore considered to be not skin sensitizing.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Reference

Reference 1

Endpoint:

skin sensitisation: in vivo (LLNA)

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

yes

Remarks:

: Deviations from the maximum level of daily mean relative humidity occured. HCD did not indicate an effect of these deviations.

Qualifier:

according to guideline

Guideline:

EU Method B.42 (Skin Sensitisation: Local Lymph Node Assay)

Deviations:

yes

Remarks:

: Deviations from the maximum level of daily mean relative humidity occured. HCD did not indicate an effect of these deviations.

GLP compliance:

yes

Type of study:

mouse local lymph node assay (LLNA)

Species:

mouse

Strain:

CBA

Sex:

female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: Young adult animals (approx. 10 weeks old)
- Weight at study initiation: variation was within ± 20% of the sex mean.
- Housing: Group housed
- Diet (e.g. ad libitum):ad libitum to pelleted rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany)
- Water (e.g. ad libitum):Free access to tap water
- Acclimation period: At least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C):18 to 24°C
- Humidity (%):40 to 70%
- Air changes (per hr):approximately 10 room air changes/hour
- Photoperiod (hrs dark / hrs light):12-hour light/12-hour dark cycle.

IN-LIFE DATES: From: 2014-07-16 To: 2014-18-04

Vehicle:

dimethylformamide

Concentration:

0, 10, 25 and 50 % (test substance w/w)

No. of animals per dose:

5

Details on study design:

RANGE FINDING TESTS:
- Two test substance concentrations were tested; a 25% and 50% concentration. The highest concentration was the maximum concentration as required in the test guidelines (50% for solids).
- Irritation: No irritation and no signs of systemic toxicity were observed in any of the animals examined.

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3 (1 per day)
- Exposure period: Days 1-3
- Test groups: 2,3,4
- Control group: 1
- Site: Dorsal surface of both ears (25 uL/ear)
- Frequency of applications: Once per day (Each ear) at approximately the same time each day
- Concentrations: 0, 10, 25 or 50% (test substance w/w)
- Exision of the nodes was undertaken on Day 6.
Each animal was injected via the tail vein with 0.25 mL of sterile phosphate buffered saline (PBS) (Merck, Darmstadt, Germany) containing 20 μCi of
3H-methyl thymidine (PerkinElmer Life and Analytical Sciences, Boston, MA, US). After approximately 5 hours animals were killed and the nodes
excised.

Positive control substance(s):

hexyl cinnamic aldehyde (CAS No 101-86-0)

Positive control results:

The SI values calculated for the substance concentrations 5, 10 and 25% were 1.2, 1.4 and 4.7 respectively. An EC3 value of 17.3% was calculated
using linear interpolation. The calculated EC3 value was found to be in the acceptable range of 4.8 and 19.5%.
Based on the results, it was concluded that the Local Lymph Node Assay as performed at WIL Research Europe is an appropriate model for testing
for contact hypersensitivity.

Key result

Parameter:

SI

Value:

1.3

Remarks on result:

other: The SI values calculated for the substance concentrations of 10 %

Key result

Parameter:

SI

Value:

1

Remarks on result:

other:

Remarks:

The SI values calculated for the substance concentration of 25 %

Key result

Parameter:

SI

Value:

1.4

Remarks on result:

other:

Remarks:

The SI values calculated for the substance concentration of 50 %

Key result

Parameter:

other: disintegrations per minute (DPM)

Remarks on result:

other: 0%: 387 ± 55 10%: 521 ± 117 25%: 368 ± 56 50%: 541 ± 54

Interpretation of results:

GHS criteria not met

Conclusions:

Based on these results, the test substance would not be regarded as a skin sensitizer according to the recommendations made in the test guidelines.

Reference 2

Endpoint:

skin sensitisation: in vitro

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Classification, Labeling, and Packaging Regulation (EC) No 1272/2008
The available data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on this data, the substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the seventeenth time in Regulation (EU) 2021/849.