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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: No GLP reference

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993
Report date:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
:no data on the observation period
Qualifier:
according to guideline
Guideline:
other: modified Department of Transportation Regulation (US), Method of testing corrosion to skin
GLP compliance:
not specified

Test material

Constituent 1
Reference substance name:
Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with triethanolamine
EC Number:
939-464-2
Cas Number:
121617-08-1
Molecular formula:
C6 H15 N O3 . C6 H6 O3 S
IUPAC Name:
Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with triethanolamine
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): Bio-Soft N300= TEA DDBS
- Analytical purity: 60%
No other data on the test material are provided.

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
not specified
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
no data
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.6
Max. score:
3
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.3
Max. score:
2
Reversibility:
no data
Irritation parameter:
erythema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
3
Max. score:
3
Reversibility:
no data
Irritation parameter:
edema score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Max. score:
2
Reversibility:
no data
Other effects:
No escharosis or necrosis observed in any of the animals tested.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
On the basis of this result the test material (60% solution) is irritating to the skin of rabbits.
Executive summary:

In a primary dermal irritation study, New Zealand white rabbits were dermally exposed to 0.5ml of Bio-Soft N300 (60% LAS TEA) for 4 hours. Irritation was scored at 4, 24, 48 and 72 h post application. In this study, Bio-Soft N300 is irritating to skin.