Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Skin sensitisation

The test substance is not sensitising to skin.

The sensitization potential of test substance was assessed in a study where one group of 20 test animals was treated with 0.4 ml of undiluted test substance for an exposure period of once weekly to 6 hours induction exposures for 3 weeks. After a 2 week rest period, both test (20) and control (10) animals were challenged with 0.4 ml of undiluted test substance.

 

On challenge with 0.4 ml of undiluted test substance, no reaction was observed in any of the test animals and conrtrol animals at both the 21 -hour and 45 -hour reading. No evidence for sensitization was observed in this study.

 

There is no indication of skin sensitization of the substance based on the available animal and human data. The chemical structure activity of these chemicals do not predict any concerns for contact sensitization.

 

Synopsis

Not sensitising

 

 

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
other: published data
Adequacy of study:
key study
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:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
Post-study body weights of animals are not mentioned.
GLP compliance:
not specified
Type of study:
Buehler test
Justification for non-LLNA method:
The in vivo study data were obtained in studies performed before any in vitro sensitization tests tests had been validated and accepted for regulatory purposes.
Specific details on test material used for the study:
Test Substance
CAS Number: 12068-03-0
Identity: Toluene sulfonic acid, sodium
salt
Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hacking and Churchill Ltd.
- Age at study initiation: Young females
- Weight at study initiation: 599-853 gm
- Housing: Caged in groups of two by dose group in grid floor propylene cages.
- Diet (e.g. ad libitum): Guinea Pig diet, standard with vitamin C, Special diets Srvices Ltd., Witham, ad libitum
- Water (e.g. ad libitum): ad libitum (A certificate for quality of drinking water was issued by the Yorkshire Water Authority)
- Acclimation period: at least 7 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-26 deg C
- Humidity (%): 40-64%
- Air changes (per hr): Not available
- Photoperiod (hrs dark / hrs light): 12/12 (artificial light, 06.00 to 18.00)
Route:
epicutaneous, occlusive
Vehicle:
other: deionized water
Concentration / amount:

One group of 20 test animals was treated with 0.4 ml of undiluted test material for an exposure period of 6 hours weekly for 3 induction exposures.
Both test (20) and control (10) animals were challenged with 0.4 ml of undiluted test material.
No.:
#1
Route:
epicutaneous, occlusive
Vehicle:
other: deionized water
Concentration / amount:
One group of 20 test animals was treated with 0.4 ml of undiluted test material for an exposure period of 6 hours weekly for 3 induction exposures.
Both test (20) and control (10) animals were challenged with 0.4 ml of undiluted test material.
Concentration / amount:
intradermal induction: 0.05% m/v in corn oil
topical induction: 5% in corn oil
topical challenge: 2.5% in corn oil
No. of animals per dose:
Induction: group of 20 test animal treated with 0.4 ml of undiluted sodium cumene sulphonate.
Range Finding test: 2 test animals were taken, for each of the following concentration- undiluted test material, 50%, 25% and 10% (v/v).
Primary challenge: 10 control animals previously untreated were treated with undiluted test material.
Details on study design:

RANGE FINDING TESTS: 2 test animals were taken, for each of the following concentration- undiluted test material, 50%, 25% and 10% (v/v).


MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 3
- Exposure period: 6 hours
- Test groups: 0.4 ml of undiluted sodium cumene sulphonate.
- Control group: None
- Site: Shaved left flank of each animal.
- Frequency of applications: once a week for 3 weeks
- Duration: 6 hours, test substance was applied to the lint pads and were held in place with an overlapping impermeable occlusive tape and secured by elastic adhesive bandage.
- Concentrations: undiluted sodium cumene sulphonate.


B. CHALLENGE EXPOSURE
- No. of exposures: One 6 hour exposure
- Day(s) of challenge: 2 weeks after the last induction exposure
- Exposure period: 6 hours under occlusion
- Test groups: 0.4 ml of undiluted sodium cumene sulphonate.
- Control group: 0.4 ml of undiluted sodium cumene sulphonate.
- Site: freshly clipped Right flank that has not been treated before.
- Concentrations: undiluted sodium cumene sulphonate.
- Evaluation (hr after challenge): 21 and 45 hours after challenge exposure


OTHER: None
Challenge controls:
10 control animals (previously unexposed) treated with 0.4 ml of undiluted sodium cumene sulphonate.
Positive control substance(s):
no
Reading:
1st reading
Hours after challenge:
21
Group:
test chemical
Dose level:
0.4 ml
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No response
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 21.0. Group: test group. Dose level: 0.4 ml of undiluted sodium cumene sulphonate. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No response.
Reading:
1st reading
Hours after challenge:
21
Group:
negative control
Dose level:
0.4 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No response
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 21.0. Group: negative control. Dose level: 0.4 ml of undiluted sodium cumene sulphonate.. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No response.
Reading:
2nd reading
Hours after challenge:
45
Group:
test chemical
Dose level:
0.4 ml
No. with + reactions:
0
Total no. in group:
20
Clinical observations:
No response
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 45.0. Group: test group. Dose level: 0.4 ml of undiluted sodium cumene sulphonate.. No with. + reactions: 0.0. Total no. in groups: 20.0. Clinical observations: No response.
Reading:
2nd reading
Hours after challenge:
45
Group:
negative control
Dose level:
0.4 ml
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No response
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 45.0. Group: negative control. Dose level: 0.4 ml of undiluted sodium cumene sulphonate.. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: No response.
Interpretation of results:
other: not sensitising
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test substance is not sensitising to skin.
The sensitization potential of test substance was assessed in a study where one group of 20 test animals was treated with 0.4 ml of undiluted test substance for an exposure period of once weekly to 6 hours induction exposures for 3 weeks. After a 2 week rest period, both test (20) and control (10) animals were challenged with 0.4 ml of undiluted test substance.

On challenge with 0.4 ml of undiluted test substance, no reaction was observed in any of the test animals and conrtrol animals at both the 21 -hour and 45 -hour reading. No evidence for sensitization was observed in this study.
Executive summary:

The test substance is not sensitising to skin.

The sensitization potential of test substance was assessed in a study where one group of 20 test animals was treated with 0.4 ml of undiluted test substance for an exposure period of once weekly to 6 hours induction exposures for 3 weeks. After a 2 week rest period, both test (20) and control (10) animals were challenged with 0.4 ml of undiluted test substance.

On challenge with 0.4 ml of undiluted test substance, no reaction was observed in any of the test animals and conrtrol animals at both the 21 -hour and 45 -hour reading. No evidence for sensitization was observed in this study.

Endpoint:
skin sensitisation: in chemico
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Link to relevant study records
Reference
Endpoint:
respiratory sensitisation: in chemico
Data waiving:
other justification
Justification for data waiving:
other:
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Justification for classification or non-classification

Based on the hazard assessment of sodium cumenesulfonate section 2.1 and 2.2. in IUCLID 6., available data for the substance and following the “Guidance on Information Requirement and Chemical Safety Assessment R.8. Characterisation of dose [concentration]- response for human health” andaccording to the criteria described in Directive 67/548 and in the CLP Regulation:

 

Directive 67/548

Respiratory Sensitisation Xn

R42 May cause sensitization by inhalation

Respiratory Irritation Xi

R37 irritating to respiratory system

 

CLP

Respiratory Sensitisation

H334 Resp. Sens. 1 May cause allergy or asthma symptoms or breath-ing difficulties if inhaled

Respiratory Irritation

H335 STOT SE 3 May cause respiratory irritation

It is concluded that the substance sodium cumenesulfonate does not meet the criteria to be classified for human health hazards for Inhalation - local effect: respiratory sensitisation.