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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

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Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
Justification for not submitting the in vitro study.
The new legal requirements (21 June 2016) require an in vitro skin irritation study. However the previous data requirements were met with an in vivo study during dossier compilation for the >1000 T/y tonnage band. Therefore there is no need to repeat the study using the alternative test method.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
N-butylbenzenesulphonamide
EC Number:
222-823-6
EC Name:
N-butylbenzenesulphonamide
Cas Number:
3622-84-2
Molecular formula:
C10H15NO2S
IUPAC Name:
N-butylbenzenesulfonamide
Details on test material:
- Name of test material (as cited in study report):N-n-butylbenzenesulphonamide (Proviplast 024) BBSA
- Physical state: clear liquid
- Analytical purity: 99.94%
- Lot/batch No.: 200911030035
- Storage condition of test material: stored at dry cool and well ventilated area in the utility room
- Other:

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: From the animal house facility of IIBAT, Padappai-601 301, Kancheepuram district, Tamil Nadu, India
- Weight at study initiation: 2.246-2.381 kg
- Housing: animals were housed individually in standard rabbit cages
- Diet (e.g. ad libitum): ad libitum standard pellet feed supplied by M/s Amrut Laboratory Animal Feed, Pune -30
- Water (e.g. ad libitum): ad libitum UV treated water
- Acclimation period:5 days prior to the experiment in the test room

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.4-21.9°C
- Humidity (%): 51-60%
- Photoperiod (hrs dark / hrs light): 12h light and 12h dark

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: closely clipping
Vehicle:
unchanged (no vehicle)
Controls:
other: untreated site was kept as control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL was evenly applied as such to the clipped area of rabbits
Duration of treatment / exposure:
4h
Observation period:
all animals were observed at 60 min, 24, 48, and 72h after removal of gauze patches
Number of animals:
3 females (nulliparous and non pregnant)
Details on study design:
TEST SITE
- Area of exposure: 6 cm2
- Type of wrap if used: non-irritating tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): test substance was removed with water
- Time after start of exposure: 4h

SCORING SYSTEM: Draize 1959 scoring

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 60 min, 24, 48, 72h
Score:
0
Max. score:
4
Reversibility:
fully reversible
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritant / corrosive response data:
No dermal reaction was seen at treated and untreated area of all animals at all time points 60 min, 24, 48, 72h.
Other effects:
None of the animals showed clinical signs of toxicity.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
It is concluded that Acute Dermal irritation/corrosion of test substance N-n-butylbenzenesulphonamide (Proviplast 024) was classified as Non-Irritant to skin of New Zealand White rabbits under the experimental conditions tested.
Executive summary:

An acute dermal irritation/corrosion was conducted with N-n-butylbenzenesulphonamide in New Zealand White Rabbits.No dermal reaction was seen at treated and untreated area of all animals at all time points 60 min, 24, 48, 72h. It is concluded that Acute Dermal irritation/corrosion of test substance was classified as Non-Irritant to skin of New Zealand White rabbits under the experimental conditions tested.