Registration Dossier

Diss Factsheets

Administrative data

Description of key information

A key acute dermal irritation/corrosion and a key eye irritation/corrosion study were conducted with N-n-butylbenzenesulphonamide in New Zealand white rabbits. The maximum mean score for skin and ocular lesions observed in the experiment were 0 in both studies, hence N-n-butylbenzenesulphonamide was considered as Non-Irritant to the skin and eye.

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:
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.
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
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: 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
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
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.
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.

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
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 eye 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.
Qualifier:
according to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. QA statement)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues 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: 2.136-2.591 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): 20.3-21.7°C
- Humidity (%): 53-66%
- Photoperiod (hrs dark / hrs light): 12h light and 12h dark
Vehicle:
not specified
Controls:
yes
Amount / concentration applied:
TEST MATERIAL

- Concentration (if solution): a volume of 0.1 ml test substance was instilled as such into the conjunctival sac of the rabbits
Duration of treatment / exposure:
the eyes of the test animals were washed after 24h
Observation period (in vivo):
72h
Number of animals or in vitro replicates:
3 females (nulliparous and non-pregnant
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, 24h after instillation


SCORING SYSTEM: Draize 1959 scoring
Irritation parameter:
overall irritation score
Basis:
animal: all 3
Time point:
other: 1h, 24h, 48h, 72h
Score:
0
Max. score:
110
Reversibility:
fully reversible
Irritation parameter:
cornea opacity score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritation parameter:
iris score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
2
Reversibility:
other: score = 0
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
3
Reversibility:
other: score = 0
Irritation parameter:
chemosis score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
4
Reversibility:
other: score = 0
Irritant / corrosive response data:
The mean score of ocular lesion is 0 +/- 0.0 at 1, 24, 48 and 72h. Non of the animals showed any lesions throughout the observation period.
Interpretation of results:
GHS criteria not met
Conclusions:
The maximum mean score for ocular lesions observed in the experiment was 0. Hence, under the experimental conditions the test substance, N-n-butylbenzenesulphonamide (Proviplast 024) was considered as Non-Irritant (N) to the eyes of New Zealand white rabbits.
Executive summary:

An acute eye irritation/corrosion study was conducted with N-n-butylbenzenesulphonamide in New Zealand white rabbits. The maximum mean score for ocular lesions observed in the experiment was 0. Hence, under the experimental conditions the test substance, N-n-butylbenzenesulphonamide was considered as Non-Irritant to the eyes of New Zealand white rabbits.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

A key acute dermal irritation/corrosion study with N-n-butylbenzenesulphonamide was conducted in New Zealand White Rabbits (IIBAT, 2010a). 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 the test substance was classified as Non-Irritant to skin of New Zealand white rabbits under the experimental conditions tested.

A key acute eye irritation/corrosion study was conducted with N-n-butylbenzenesulphonamide in New Zealand white rabbits (IIBAT, 2010b). The maximum mean score for ocular lesions observed in the experiment was 0. Hence, under the experimental conditions the test substance, N-n-butylbenzenesulphonamide was considered as Non-Irritant to the eyes of New Zealand white rabbits.


Justification for selection of skin irritation / corrosion endpoint:
Key study

Justification for selection of eye irritation endpoint:
Key study

Justification for classification or non-classification

Based on the results and according to the EC criteria for classification and labelling requirements for dangerous substances and preparations (Guidelines in Commission Directive 93/21/EEC) and CLP regulation (EC No. 1272/2008 of 16 December 2008), N-butylbenzenesulphonamide does not have to be classified and has no obligatory labelling requirement for skin and eye irritation/corrosion.