Registration Dossier
Registration Dossier
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EC number: 247-557-8 | CAS number: 26264-06-2
Carcinogenicity
Administrative data
Description of key information
The study of Buehler, E.V., Newmann, E.A., and King, W.R.1971 consistently showed lack of evidence of carcinogenicity in rats.
There is no reason to believe that C10-14 LAS (Benzenesulfonic acid, C10-14-alkyl derivs., sodium salts as a read across for Calcium dodecylbenzenesulfonate) has carcinogenic potential.
NOAEL:250mg/kg bw/day
The NOAEL is the highest tested dose.
There are conclusive but not suffcient data for the classification of substance Calcium dodecylbenzenesulfonate with regard to carcinogenicity.
Carcinogenicity: IARC, NTP, ACGIH and OSHA do not classify this substance or its components as a carcinogen or suspect carcinogen.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Benzenesulfonic acid, C10-14-alkyl derivs., sodium salts is a very close analogue of Calcium dodecylbenzenesulfonate (CAS No 26264-06-2, EC Number; 247-557-8) ) and read-across is valid.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: Four groups of Charles River weanling rats, divided by sex, were given 0.5, 0.1, and 0.02% LAS in their food for 2 years. Following completion of those studies, five male and five female rats from each of the parental groups (F1b and F2b) and all survivors were selected for necropsy. Body weight and organ to body weight ratios were recorded, and routine hematology and histology were performed. Weanling animals for the F3a generation were similarly treated.
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- other: Charles River
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: 21 days
- Weight at study initiation: (P) Males: average 59.4-59.9 g; Females: average 57.0-57.3 g;
- Housing: individual wire bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 76 +/- 3
- Humidity (%): 50 +/- 5
- Photoperiod (hrs dark / hrs light): 12/12 hrs - Route of administration:
- oral: feed
- Vehicle:
- other: LAS was administered in feed (Purina Laboratory Meal) - no documentation of dilution prior to addition to meal
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- continuous in feed
- Remarks:
- Doses / Concentrations:
0.02, 0.1, 0.5% (10, 50, 250 mg/kg bw d)
Basis:
nominal conc. - No. of animals per sex per dose:
- Fifty animals per dose group and sex were tested.
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- A test was conducted on male/female rats. Doses of LAS (98.1%) of 0.02%, 0.1% and 0.5% (10, 50, 250 mg/kg bw/day) were administered for 2 years in the diet. A control group was used.
- Observations and examinations performed and frequency:
- Fifty animals per dose group and sex were tested. Adverse effects on growth or feed efficiency were not observed during the experiment.
- Sacrifice and pathology:
- Five males and females from each of the groups at 8 and 15 months and all survivors at 24 months were necrospied, haematologic values were determined, and tissues were taken for histologic studies.
- Other examinations:
- These examinations revealed no consistent dietary-induced changes, which could be considered a toxic response. In addition, animals, which showed significant loss of weight, development of tumours or other evidence of abnormalities, were sacrificed and tissues were preserved for study. The incidence of tumours and the common incidental diseases were similar in all dietary groups.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Gross examination of all animals for pathology did not reveal any abnormalities. No consistent dietary induced changes that could be considered a toxic response were observed. Animals that showed significant loss of weight, development of tumors, or other evidence of abnormalities were sacrificed and tissues examined. The incidence of tumors and the common incidental diseases were similar in all dieting groups.
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: The NOAEL is the highest tested dose.
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- The study consistently showed lack of evidence of carcinogenicity in rats. There is no reason to believe that LAS has carcinogenic potential.
NOAEL:250mg/kg bw/day
The NOAEL is the highest tested dose. - Executive summary:
A test was conducted on male/female rats.Doses of LAS (98.1%) of 0.02%, 0.1% and 0.5% (10, 50, 250 mg/kg bw/day) were administered for 2 years in the diet. A control group was used.
Fifty animals per dose group and sex were tested. Adverse effects on growth or feed efficiency were not observed during the experiment. Five males and females from each of the groups at 8 and 15 months and all survivors at 24 months were necrospied, haematologic values were determined, and tissues were taken for histologic studies.
These examinations revealed no consistent dietary-induced changes, which could be considered a toxic response. In addition, animals, which showed significant loss of weight, development of tumours or other evidence of abnormalities, were sacrificed and tissues were preserved for study. The incidence of tumours and the common incidental diseases were similar in all dietary groups.
The study consistently showed lack of evidence of carcinogenicity in rats. There is no reason to believe that LAS has carcinogenic potential.
NOAEL:250mg/kg bw/day
The NOAEL is the highest tested dose.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 250 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Carcinogenicity: via inhalation route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Benzenesulfonic acid, C10-14-alkyl derivs., sodium salts is a very close analogue of Calcium dodecylbenzenesulfonate (CAS No 26264-06-2, EC Number; 247-557-8) ) and read-across is valid.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: Four groups of Charles River weanling rats, divided by sex, were given 0.5, 0.1, and 0.02% LAS in their food for 2 years. Following completion of those studies, five male and five female rats from each of the parental groups (F1b and F2b) and all survivors were selected for necropsy. Body weight and organ to body weight ratios were recorded, and routine hematology and histology were performed. Weanling animals for the F3a generation were similarly treated.
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- other: Charles River
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: 21 days
- Weight at study initiation: (P) Males: average 59.4-59.9 g; Females: average 57.0-57.3 g;
- Housing: individual wire bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 76 +/- 3
- Humidity (%): 50 +/- 5
- Photoperiod (hrs dark / hrs light): 12/12 hrs - Route of administration:
- oral: feed
- Vehicle:
- other: LAS was administered in feed (Purina Laboratory Meal) - no documentation of dilution prior to addition to meal
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- continuous in feed
- Remarks:
- Doses / Concentrations:
0.02, 0.1, 0.5% (10, 50, 250 mg/kg bw d)
Basis:
nominal conc. - No. of animals per sex per dose:
- Fifty animals per dose group and sex were tested.
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- A test was conducted on male/female rats. Doses of LAS (98.1%) of 0.02%, 0.1% and 0.5% (10, 50, 250 mg/kg bw/day) were administered for 2 years in the diet. A control group was used.
- Observations and examinations performed and frequency:
- Fifty animals per dose group and sex were tested. Adverse effects on growth or feed efficiency were not observed during the experiment.
- Sacrifice and pathology:
- Five males and females from each of the groups at 8 and 15 months and all survivors at 24 months were necrospied, haematologic values were determined, and tissues were taken for histologic studies.
- Other examinations:
- These examinations revealed no consistent dietary-induced changes, which could be considered a toxic response. In addition, animals, which showed significant loss of weight, development of tumours or other evidence of abnormalities, were sacrificed and tissues were preserved for study. The incidence of tumours and the common incidental diseases were similar in all dietary groups.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Gross examination of all animals for pathology did not reveal any abnormalities. No consistent dietary induced changes that could be considered a toxic response were observed. Animals that showed significant loss of weight, development of tumors, or other evidence of abnormalities were sacrificed and tissues examined. The incidence of tumors and the common incidental diseases were similar in all dieting groups.
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: The NOAEL is the highest tested dose.
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- The study consistently showed lack of evidence of carcinogenicity in rats. There is no reason to believe that LAS has carcinogenic potential.
NOAEL:250mg/kg bw/day
The NOAEL is the highest tested dose. - Executive summary:
A test was conducted on male/female rats.Doses of LAS (98.1%) of 0.02%, 0.1% and 0.5% (10, 50, 250 mg/kg bw/day) were administered for 2 years in the diet. A control group was used.
Fifty animals per dose group and sex were tested. Adverse effects on growth or feed efficiency were not observed during the experiment. Five males and females from each of the groups at 8 and 15 months and all survivors at 24 months were necrospied, haematologic values were determined, and tissues were taken for histologic studies.
These examinations revealed no consistent dietary-induced changes, which could be considered a toxic response. In addition, animals, which showed significant loss of weight, development of tumours or other evidence of abnormalities, were sacrificed and tissues were preserved for study. The incidence of tumours and the common incidental diseases were similar in all dietary groups.
The study consistently showed lack of evidence of carcinogenicity in rats. There is no reason to believe that LAS has carcinogenic potential.
NOAEL:250mg/kg bw/day
The NOAEL is the highest tested dose.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEC
- 10.87 mg/m³
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- There are no Inhalation Carcinogenic studies available.
The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes.
NOAEL rat 250 mg/kg bw/day
÷1.15m3/kgbw
÷20m3/mice
NOAECrat 10.87mg/m3
Carcinogenicity: via dermal route
Link to relevant study records
- Endpoint:
- carcinogenicity: oral
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Benzenesulfonic acid, C10-14-alkyl derivs., sodium salts is a very close analogue of Calcium dodecylbenzenesulfonate (CAS No 26264-06-2, EC Number; 247-557-8) ) and read-across is valid.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Method: Four groups of Charles River weanling rats, divided by sex, were given 0.5, 0.1, and 0.02% LAS in their food for 2 years. Following completion of those studies, five male and five female rats from each of the parental groups (F1b and F2b) and all survivors were selected for necropsy. Body weight and organ to body weight ratios were recorded, and routine hematology and histology were performed. Weanling animals for the F3a generation were similarly treated.
- GLP compliance:
- not specified
- Species:
- rat
- Strain:
- other: Charles River
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories
- Age at study initiation: 21 days
- Weight at study initiation: (P) Males: average 59.4-59.9 g; Females: average 57.0-57.3 g;
- Housing: individual wire bottom cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 76 +/- 3
- Humidity (%): 50 +/- 5
- Photoperiod (hrs dark / hrs light): 12/12 hrs - Route of administration:
- oral: feed
- Vehicle:
- other: LAS was administered in feed (Purina Laboratory Meal) - no documentation of dilution prior to addition to meal
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 2 years
- Frequency of treatment:
- continuous in feed
- Remarks:
- Doses / Concentrations:
0.02, 0.1, 0.5% (10, 50, 250 mg/kg bw d)
Basis:
nominal conc. - No. of animals per sex per dose:
- Fifty animals per dose group and sex were tested.
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- A test was conducted on male/female rats. Doses of LAS (98.1%) of 0.02%, 0.1% and 0.5% (10, 50, 250 mg/kg bw/day) were administered for 2 years in the diet. A control group was used.
- Observations and examinations performed and frequency:
- Fifty animals per dose group and sex were tested. Adverse effects on growth or feed efficiency were not observed during the experiment.
- Sacrifice and pathology:
- Five males and females from each of the groups at 8 and 15 months and all survivors at 24 months were necrospied, haematologic values were determined, and tissues were taken for histologic studies.
- Other examinations:
- These examinations revealed no consistent dietary-induced changes, which could be considered a toxic response. In addition, animals, which showed significant loss of weight, development of tumours or other evidence of abnormalities, were sacrificed and tissues were preserved for study. The incidence of tumours and the common incidental diseases were similar in all dietary groups.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- Gross examination of all animals for pathology did not reveal any abnormalities. No consistent dietary induced changes that could be considered a toxic response were observed. Animals that showed significant loss of weight, development of tumors, or other evidence of abnormalities were sacrificed and tissues examined. The incidence of tumors and the common incidental diseases were similar in all dieting groups.
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: The NOAEL is the highest tested dose.
- Remarks on result:
- other: Effect type: carcinogenicity (migrated information)
- Conclusions:
- The study consistently showed lack of evidence of carcinogenicity in rats. There is no reason to believe that LAS has carcinogenic potential.
NOAEL:250mg/kg bw/day
The NOAEL is the highest tested dose. - Executive summary:
A test was conducted on male/female rats.Doses of LAS (98.1%) of 0.02%, 0.1% and 0.5% (10, 50, 250 mg/kg bw/day) were administered for 2 years in the diet. A control group was used.
Fifty animals per dose group and sex were tested. Adverse effects on growth or feed efficiency were not observed during the experiment. Five males and females from each of the groups at 8 and 15 months and all survivors at 24 months were necrospied, haematologic values were determined, and tissues were taken for histologic studies.
These examinations revealed no consistent dietary-induced changes, which could be considered a toxic response. In addition, animals, which showed significant loss of weight, development of tumours or other evidence of abnormalities, were sacrificed and tissues were preserved for study. The incidence of tumours and the common incidental diseases were similar in all dietary groups.
The study consistently showed lack of evidence of carcinogenicity in rats. There is no reason to believe that LAS has carcinogenic potential.
NOAEL:250mg/kg bw/day
The NOAEL is the highest tested dose.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 6.25 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- There are no dermal Carcinogenic studies available.
For dermal exposure we taken that:
-the average weight of rats is 250g (200-300g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg
corrected dermal NOAEL= oral NOAEL
250 mg/kg bw/day x 0.025 kg =
NOAELrat = 6.25 mg/kg bw/day
Justification for classification or non-classification
Based on the hazard assessment of Calcium dodecylbenzenesulfonate in section 2.1 and 2.2. in IUCLID 5.4., 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 |
Carcinogenicity Carc. Cat. 1; R45 May cause cancer. Carc. Cat. 1; R49 May cause cancer by inhalation. Carc. Cat. 2; R45 May cause cancer. Carc. Cat. 2; R49 May cause cancer by inhalation. Carc. Cat. 3; R40 Limited evidence of a carcinogenic effect.
|
CLP |
Carcinogenicity Carc. 1A Carc. 1B Carc. 2 H350: May cause cancer <state route of exposure if it is conclusively proven that no other routes of exposure cause the hazard>. H351: Suspected of causing cancer <state route of exposure if it is conclusively proven that no other routs of exposure cause the hazard>. |
It is concluded that the Calcium dodecylbenzenesulfonate does not meet the criteria to be classified for human health hazards for Carcinogenicity.
Additional information
Oral effects:
The study of Buehler, E.V., Newmann, E.A., and King, W.R.1971consistently showed lack of evidence of carcinogenicity in rats.
There is no reason to believe that C10-14LAS (Benzenesulfonic acid, C10-14-alkyl derivs., sodium salts as a read across for Calcium dodecylbenzenesulfonate) has carcinogenic potential.
A test was conducted on male/female rats.Doses of C10-14LAS (98.1%) of 0.02%, 0.1% and 0.5% (10, 50, 250 mg/kg bw/day) were administered for 2 years in the diet. A control group was used.
Fifty animals per dose group and sex were tested. Adverse effects on growth or feed efficiency were not observed during the experiment. Five males and females from each of the groups at 8 and 15 months and all survivors at 24 months were necrospied, haematologic values were determined, and tissues were taken for histologic studies.
These examinations revealed no consistent dietary-induced changes, which could be considered a toxic response. In addition, animals, which showed significant loss of weight, development of tumours or other evidence of abnormalities, were sacrificed and tissues were preserved for study. The incidence of tumours and the common incidental diseases were similar in all dietary groups.
The study consistently showed lack of evidence of carcinogenicity in rats.
There is no reason to believe that C10-14LAS (Benzenesulfonic acid, C10-14-alkyl derivs., sodium salts as a read across for Calcium dodecylbenzenesulfonate) has carcinogenic potential.
NOAEL:250mg/kg bw/day
The NOAEL is the highest tested dose.
Inhalation effects:
There are no Inhalation Carcinogenic studies available.
The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes.
NOAEL rat 250 mg/kg bw/day
÷1.15m3/kgbw
÷20m3/mice
NOAECrat 10.87mg/m3
Dermal Effects:
There are no dermal Carcinogenic studies available.
For dermal exposure we taken that:
-the average weight of rats is 250g (200-300g),
-the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg
corrected dermal NOAEL= oral NOAEL
250 mg/kg bw/day x 0.025 kg =
NOAELrat = 6.25 mg/kg bw/day
Carcinogenicity: via oral route (target organ): other: all gross lesions and masses
Carcinogenicity: via inhalation route (target organ): respiratory: lung; other: all gross lesions and masses
Carcinogenicity: via dermal route (target organ): other: skin
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
