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Diss Factsheets

Administrative data

Description of key information

The ASA Category comprises the following 5 aromatic sulphonic acids:


TSA, Toluene-4-sulphonic acid (EC 203-180-0, CAS 104-15-4)


XSA, (Xylenes and 4-ethylbenzene) sulphonic acid (EC 701-247-3, CAS -) Former EC 246-839-8


CSA, p-cumene sulphonic acid (EC 240-210-1, CAS 16066-35-6)


BSA, Benzene sulphonic acid (EC 202-638-7, CAS 98-11-3)


HBSA, 4-hydroxybenzensulphonic acid (EC No. 202-691-6, CAS No. 98-67-9)


The skin sensitisation potential was assessed with available test on ASA and related salt (Hydrotropes substances). There is a single, key study for sensitization of the aromatic sulphonic acids performed on TSA. None of the tested animals showed positive responses in a, well documented, GLP guinea pig sensitization study (Hoechst, 1988). The test substance can be considered a non-sensitizer in guinea pigs as none of the test animals showed a positive response to combined intradermal and topical induction followed by topical challenge. The test on TSA was used in read across for XSA due to the chemical similarity between the two substances.
Further supporting information of the sensitising potential can be derived by the analogous category of Hydrotropes, for which some members (Cumene and Toluene derivatives) have been tested always with negative results. The test on cumene sulphonate was used in read across for CSA and the test on STS is used to support the absence of sensitization effects of TSA.


Based on the chemical similarity among ASA and Hydrotropes substances it is reasonable to consider the substances of this two categories as not skin sensitizer.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1.11.1988-9.12.1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment
Qualifier:
according to guideline
Guideline:
EU Method B.6 (Skin Sensitisation)
Deviations:
yes
Remarks:
lower number of test animals
Principles of method if other than guideline:
Acceptable method
GLP compliance:
yes (incl. QA statement)
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The test was already existing
Species:
guinea pig
Strain:
other: Pirbright
Sex:
female
Details on test animals and environmental conditions:
Supplier: Hoechst AG, Kastengrund, SPF-Zucht
Weight: 310-394 g
Housing: Makrolon cages (type 4), Weichholz-granulate bedding, 5 animals per cage, air conditioned system
Temperature: 22 ± 3 °C
Relative Humidity: 50 ± 20 %
Phot period: 12h/12h
Food: ad libitum feed for animals (Supplier: ERKA- Mishfutter Nr. 8300)
Water: ad libitum, tap water
Acclimation: 5 days



Route:
intradermal and epicutaneous
Vehicle:
physiological saline
Concentration / amount:
0.2 %
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
physiological saline
Concentration / amount:
10 %
Adequacy of challenge:
not specified
No. of animals per dose:
10 females in test group and 5 females in control group
Reading:
1st reading
Group:
positive control
Remarks on result:
positive indication of skin sensitisation
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
10% in saline solution
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no positive response
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: test group. Dose level: 10% in saline solution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no positive response.
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
10% in saline solution
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
no positive response
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: test group. Dose level: 10% in saline solution. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: no positive response.
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
10% in saline solution
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no positive response
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 10% in saline solution. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no positive response.
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
10% in saline solution
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
no positive response
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 72.0. Group: negative control. Dose level: 10% in saline solution. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: no positive response.

See attached tables for details.

Interpretation of results:
GHS criteria not met
Conclusions:
Not skin sensitizer
Executive summary:

The skin sensitization potential of Toluene 4-sulphonic acid was assessed following official EU Method B.6, Skin sensitization. None of the tested animals showed positive responses and the test substance can be considered a non-sensitizer in guinea pigs.

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

Justification for classification or non-classification

There is no human or animal evidence of skin sensitization effects therefore no classification is requested based on Regulation (CE) 1272/2008.