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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2/08 - 16-08 1995
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
no information provided on control animals

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

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-butyl benzenesulphonamide (BBSA)
- Substance type: mono constituent substance-organic
- Physical state: clear, colourless liquid
- Analytical purity: 99.91%
- Impurities (identity and concentrations): 0.1% Diphenylsulphon/0.1% water/0.1% Butylbenzeensulphate/0.02% Butylamine
- Composition of test material, percentage of components: 99.91% N-n-butyl benzenesulphonamide
- Isomers composition:
- Purity test date: 11/09/94
- Lot/batch No.: 0/941109
- Expiration date of the lot/batch: ≥ 20 July 1995
- Stability under test conditions: stable
- Storage condition of test material: room temperature in the dark
- Other:

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Harlan Olac Ltd, Bicester, Oxon, England
- Age at study initiation: 7 - 10 weeks
- Weight at study initiation: 220 to 250g
- Fasting period before study: no
- Housing: the rats were allocated without conscious bias to cages within the treatment group. They were housed individually in metal cages with wire mesh floors in building R14 room 6.
- Diet (e.g. ad libitum): standard laboratory rodent diet (SDS LAD 1) were provided ad libitum, each batch of diet used for the study was analysed for certain nutrients, possible contaminants and micro-organismes.
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days prior to the start of the study.


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+-3°c
- Humidity (%): 30 - 70% RH
- Air changes (per hr): 10 to 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours of artificial light in each 24-hour period.


IN-LIFE DATES: From: 2/08 - 16-08-1995 To: 16-08 1995

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: the dorso-lumbar region
- % coverage: 10%
- Type of wrap if used: covered with gauze which was held in place with a non-irritative dressing encircled firmly around the trunk.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): the treated area of skin was washed with warm (30-40°c) water and blotted dry with absorbent paper.
- Time after start of exposure: 24h


TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 1,8 ml/kg bodyweight
- Concentration (if solution): /
- Constant volume or concentration used: yes/no
- For solids, paste formed: yes/no


VEHICLE
- Amount(s) applied (volume or weight with unit): /
- Concentration (if solution): /
- Lot/batch no. (if required): /
- Purity: /
Duration of exposure:
24h during 15 days.
Doses:
1,8 ml/kg bodyweight
No. of animals per sex per dose:
a group of 10 rats (5 males and 5 females) was treated at 2,0 g/kg bodyweight
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days (or other?) 14 days after dosing.
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1 (a period of approximately five hours). On subsequent days animals were observed once in the morning and again at the end of the experimental day. This latter observations was at approximately 16.30 hours on week days or 11.30 hours on Saturdays and Sundays. The nature and severity of the clinical signs and time were recorded at each observation.
Individual body weight were recorded on Days 1, 8 and 15. Individual weekly bodyweight changes and group mean bodyweight data were calculated.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, other: mortality, dermal respons, macroscopic examintion
Statistics:
NO DATA

Results and discussion

Preliminary study:
standard acute method
Effect levels
Key result
Sex:
male/female
Dose descriptor:
discriminating dose
Effect level:
2 000 mg/kg bw
Mortality:
There were no deaths following a single dermal application of BBSA at a dosage of 2,0 g/kg bw.
Clinical signs:
other: There were no signs of systemic reaction to treatment.
Gross pathology:
No macroscopic abnormalities were observed for animals killed on day 15.
Other findings:
- Organ weights: /
- Histopathology: /
- Potential target organs: /
- Other observations: dermal responses: Sites of application of BBSA showed no irritation or other dermal changes (scores of zero for erythema and oedema were recorded for all animals).

Any other information on results incl. tables

Dermal response

Local dermal irritation at the treatment site was assessed daily using the following numerical system:

 

Erythema and eschar formation:

No erythema:  0

Slight erythema:  1

Well-defined erythema:  2

Moderate erythema:  3

Severe erythema (beet redness) to slight eschar formation (injuries in depth):  4

Oedema formation:   

No oedema:  0

Slight oedema:  1

Well-defined oedema (edges of area well-defined by definite rising):  2

Moderate oedema (raised approximately 1 mm):  3

Severe oedema (raised more than 1 mm and extending beyond the area of exposure):  4

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute lethal dermal dose to rats of BBSA was found to be greater than 2,0 g/kg bodyweight.
Executive summary:

Acute dermal toxicity was tested in Spraque-Dawley rats at 2.0 g/kg under occlusive dressing. The acute lethal dermal dose to rats of BBSA was found to be greater than 2,0 g/kg bodyweight. No macroscopic abnormalities were observed for animals killed on day 15.

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