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Diss Factsheets

Administrative data

Description of key information

No experimental data are available for the target substance C16 IOS-Na.


 


A negative in-vivo skin sensitisation study according to OECD TG 406 (GPMT) is available for the closely related source substance 1(C16-18 IOS-Na C16-rich).


 


The skin sensitization potential of C16-18 IOS-Na C16-rich was examined in guinea pigs according to the maximization test method. A total of 15 animals were used in the following groups: 10 animals in the test-substance sensitization group and 5 animals in the control group. Observation of skin reaction was performed 24 and 48 hours after patch removal.


 


As a result, no skin reaction was noted at any test concentration in either of the test-substance sensitization group or control group. During the observation period, no abnormalities were found in the general condition of the animals, and weight gain was satisfactory. In conclusion, the test substance has no skin-sensitization potential based on the above results.


 


According to the criteria of the CLP criteria the test substance does not have to be classified as skin sensitising.


 


Absence of critical impurities sultones (unsaturated 1,3-sultons and chloro sultones) was analytically proven for the target and source substance.


 


Sultones are below the limit of detection of 1 mg/kg (ppm).


Target (C16 IOS): <1 mg/kg


Source-1 (C16/18 IOS C16-rich): < 1 mg/kg


 


The result for source substance 1 can be also applied for the target substance because the minor structural differences between the target substance and source substance 1 are not expected to have an impact on the skin sensitising potential. 


 

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:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
1. HYPOTHESIS FOR THE ANALOGUE APPROACH
This read-across is based on the hypothesis that source and target substances have similar (eco)toxicological properties because
Source and target substances share structural similarities (predominantly linear aliphatic hydrocarbon chain) with a common functional group: (polar sulfonate group). The molecular structure is almost identical.
They are manufactured from similar resp. identical precursors under similar conditions. Therefore, common breakdown products via physical and biological processes, which result in structurally similar chemicals are evident. Target and source substances are both a mixture of linear long chain Sulfonic acids, alkene, sodium salts and Sulfonic acids, alkane hydroxy, sodium salts and share an identical counter ion. A constant pattern in the changing of the potency of the properties across the target and source substances by chain-length and is not observed, because the distribution is too narrow.

Therefore, read-across from the existing toxicity studies on the source substance, is considered as an appropriate adaptation to the standard information requirements of Annex VII, 8.1, 8.2, 8.3, 8.4, 8.5 as well as 9.1 and 9.2 of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.

2. SOURCE AND TARGET CHEMICAL(S) (INCLUDING INFORMATION ON PURITY AND IMPURITIES)
see cross reference to assessment report: Justification for read-across document attached to section 13

3. ANALOGUE APPROACH JUSTIFICATION
see cross reference to assessment report: Justification for read-across document attached to section 13

4. DATA MATRIX
see cross reference to assessment report: Justification for read-across document attached to section 13
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across: supporting information
Type of study:
guinea pig maximisation test
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, Sulfonic acids, C16-alkane hydroxy and C16-alkene, sodium salts has no skin-sensitization potential based on the results with a structurally similar substance.
Executive summary:

This read-across is based on the hypothesis that source and target substances have similar (eco)toxicological properties because


Source and target substances share structural similarities (predominantly linear aliphatic hydrocarbon chain) with a common functional group: (polar sulfonate group). The molecular structure is almost identical.


They are manufactured from similar resp. identical precursors under similar conditions. Therefore, common breakdown products via physical and biological processes, which result in structurally similar chemicals are evident. Target and source substances are both a mixture of linear long chain Sulfonic acids, alkene, sodium salts and Sulfonic acids, alkane hydroxy, sodium salts and share an identical counter ion. A constant pattern in the changing of the potency of the properties across the target and source substances by chain-length and is not observed, because the distribution is too narrow.


 


Therefore, read-across from the existing guinea pig maximisation test on the source substance, is considered as an appropriate adaptation to the standard information requirements of Annex VII, 8.3.2 of the REACH Regulation for the target substance, in accordance with the provisions of Annex XI, 1.5 of the REACH Regulation.

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From 28th September 2012 to 6th December 2012
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
LLNA was considered not to be suitable for the test substance.
Specific details on test material used for the study:
Expiry/retest date: 31 December 2012
Species:
guinea pig
Strain:
Hartley
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Slc: Hartley, closed colony, SPF
- Age at study initiation: 5 Weeks old
- Weight at study initiation: 301–328 g
- Housing: The animals were housed 5 or 6 per cage during the quarantine and acclimatization period, and 5 per cage during the experimental period.
- Diet: Pellet diet RC4 was offered ad libitum.
- Water: Municipal tap water filtered through a 5 -μm cartridge filter was offered ad libitum through an automatic water-supply system.
- Acclimation period: For 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.9–24.6
- Humidity (%): 45.8%–64.1
- Air changes (per hr): 12 Times /hour
- Photoperiod (hrs dark / hrs light): 12 Hours/day (on at 6:00 AM, off at 6:00 PM)
Route:
intradermal and epicutaneous
Vehicle:
water
Concentration / amount:
For intradermal sensitization: 0.05 w/w%
For contact sensitization: 0.5 w/w%
Day(s)/duration:
For contact sensitization: 48 hours
Adequacy of induction:
highest concentration used causing mild-to-moderate skin irritation and well-tolerated systemically
Route:
epicutaneous, occlusive
Vehicle:
water
Concentration / amount:
For challenge: 0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
Day(s)/duration:
24 hours
Adequacy of challenge:
highest non-irritant concentration
No. of animals per dose:
10 animals in the test-substance sensitization group
5 animals in the control group
Details on study design:
RANGE FINDING TESTS: In the preliminary study conducted under non-GLP conditions (study No. 1217-[1]), the test-substance solutions at 10, 5, 3, 1, 0.5, 0.3, 0.1, 0.05, 0.03, 0.01, 0.005, and 0.003 w/w% were intradermally administered. As a result, the solutions at 10, 5, 3, 1, 0.5, and 0.3 w/w% induced necrosis; the solution at 0.1w/w% induced subtle erythema to erythema with edema; and the solution at 0.05 w/w% induced subtle erythema. After occlusive application of the test-substance solutions at 5, 3, 1, 0.5, 0.3, and 0.1 w/w%, the solutions at 5 and 3 w/w% induced erythema of Score 4 (Score 4 means eschar) with edema of Scores 2 or 3; the solution at 1 w/w% induced erythema of Scores 1 through 4 (Score 4 means eschar) with edema of Score 1; and the solution at 0.5w/w% solution induced erythema of Score 1. Based on the above results, 0.05 w/w% was selected for intradermal sensitization; 0.5 w/w%, for contact sensitization; and 6 concentrations of 0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%, for challenge.

MAIN STUDY
A. INDUCTION EXPOSURE
For intradermal sensitization of the test-substance group, 0.1 mL each of the following 3 test materials were intradermally injected into 2 sites of the cervical region of the guinea pigs:
A, an emulsion of equal volumes of Freund’s complete adjuvant (FCA) and physiological saline;
B, the test-substance solution at 0.05w/w% (vehicle: physiological saline);
C, an emulsion of equal volumes of the test-substance solution at 0.1 w/w% (vehicle: physiological saline) and FCA.
For contact sensitization, 0.2 mL of the test-substance solution at 0.5 w/w% (vehicle: water for injection) was impregnated into a 2×4-cm piece of lint cloth on the day 7, followed by occlusive application to the sites for intradermal injection for 48 hours.
The control animals were treated in the same manner with the vehicles for each sensitization.

B. CHALLENGE EXPOSURE
For challenge, 0.1 mL each of the test-substance solutions at 0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w% (vehicle: water for injection) was impregnated into 1.5×1.5-cm pieces of lint cloth on the day 21 of the sensitization, and 24-hour occlusive application was made on the right and left lateral region.
Observation of skin reaction was performed 24 and 48 hours after patch removal.
Positive control substance(s):
not required
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Key result
Reading:
1st reading
Hours after challenge:
48
Group:
negative control
Dose level:
0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
test chemical
Dose level:
0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Key result
Reading:
2nd reading
Hours after challenge:
72
Group:
negative control
Dose level:
0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No abnormalities were found in the general condition of the animals, and weight gain was satisfactory.
Interpretation of results:
GHS criteria not met
Conclusions:
In conclusion, the test substance has no skin-sensitization potential based on the above results.
Executive summary:

The skin sensitization potential of Internal Olefin Sulfonate was examined in guinea pigs according to the maximization test method. A total of 15 animals were used in the following groups: 10 animals in the test-substance sensitization group and 5 animals in the control group.


 


For intradermal sensitization of the test-substance group, 0.1 mL each of the following 3 test materials were intradermally injected into 2 sites of the cervical region of the guinea pigs: A, an emulsion of equal volumes of Freund's complete adjuvant (FCA) and physiological saline; B, the test-substance solution at 0.05w/w% (vehicle: physiological saline); C, an emulsion of equal volumes of the test-substance solution at 0.1 w/w% (vehicle: physiological saline) and FCA. For contact sensitization, 0.2 mL of the test-substance solution at 0.5 w/w% (vehicle: water for injection) was impregnated into a 2×4-cm piece of lint cloth on the day 7, followed by occlusive application to the sites for intradermal injection for 48 hours. The control animals were treated in the same manner with the vehicles for each sensitization. For challenge, 0.1 mL each of the test-substance solutions at 0.3, 0.1, 0.05, 0.03, 0.01, and 0.005 w/w% (vehicle: water for injection) was impregnated into 1.5×1.5-cm pieces of lint cloth on the day 21 of the sensitization, and 24-hour occlusive application was made on the right and left lateral region. Observation of skin reaction was performed 24 and 48 hours after patch removal.


 


As a result, no skin reaction was noted at any test concentration in either of thetest-substance sensitization group or control group. During the observation period, no abnormalities were found in the general condition of the animals, and weight gain was satisfactory. In conclusion, the test substance has no skin-sensitization potential based on the above results.

Endpoint:
skin sensitisation: in vitro
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

No skin reaction was noted at any test concentration in either of the test-substance sensitization group or control group. During the observation period, no abnormalities were found in the general condition of the animals, and weight gain was satisfactory. In conclusion, the test substance has no skin-sensitization potential based on the above results.


 


According to the criteria of the CLP criteria the substance does not have to be classified as skin sensitising and labelling is not necessary.