Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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-4-methylbenzene-1-sulfonamide
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).