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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: pre-GLP

Data source

Reference
Reference Type:
other: Certificate of analysis
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
other: Not specified

Test material

Constituent 1
Chemical structure
Reference substance name:
N-ethyl-o(or p)-toluenesulphonamide
EC Number:
232-465-2
EC Name:
N-ethyl-o(or p)-toluenesulphonamide
Cas Number:
8047-99-2
Molecular formula:
C9H13NO2S
IUPAC Name:
N-ethyl-o(or p)-toluenesulphonamide
Test material form:
liquid: viscous
Remarks:
Colour: light yellow
Details on test material:
Ketjenflex 8 (NETSA)
Chemical name in report: N-ethyl-o/p-toluenesulfonamide (or N-substituted toluene sulphonamide)
Description: light yellow viscous liquid
Purity 100% (or 90%)

Test substance storage: at room temperature in the dark
Stability under storage conditions: stable

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
not specified
Details on test animals or test system and environmental conditions:
Initial weight:
- Male: 1.9 kg
- Female: 1.8 and 2.2

Details on other conditions and test animal was not provided

Administration / exposure

Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Remarks:
Applied undiluted
Details on dermal exposure:
Information not provided
Duration of exposure:
24 hours
Doses:
5,010 and 7,940 Mg/Kg
No. of animals per sex per dose:
1
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no information
- Necropsy of survivors performed: no information
- Other examinations performed: signs of intoxication, gross autopsy decedents, survivors
Statistics:
No information

Results and discussion

Effect levels
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 7 940 mg/kg bw
Based on:
test mat.
Mortality:
Reduced appetite and activity ( three to five days)
Other findings:
Survivors ( 14 days): Viscera appeared normal

Applicant's summary and conclusion

Interpretation of results:
other: Not classified
Remarks:
according to the EU classification criteria outlined in Annex I of 1272/2008/EC (CLP)
Conclusions:
The LD50 of Santicizer 8 in rabbits after 24 hours was > 7940 mg/kg bw under the conditions of this test.
Executive summary:

To determine the dermal toxicity of Santicizer 8, an acute dermal toxicity study was performed on three New Zealand albino rabbits at a dosage level of 5010 and 7940 mg/kg bw. The LD50 of the test substance after 24 hours was > 7940 mg/kg bw under the conditions of this test. Santicizer 8 therefore does not have to be classified for acute dermal toxicity.

As a result, the substance N-Ethyl-o (or p)-toluenesulfonamide (NETSA) does not need to be classified for acute dermal toxicity according to the classification criteria outlined in Annex I of 1272/2008/EC (CLP).