Calcium dodecylbenzenesulphonate

Endpoint summary

Description of key information

- Acute oral toxicity: LD50 in male/female rats is 1300 mg/kg bw. No significant gross abnormalities were seen at autopsy. This show that Calcium dodecylbenzenesulphonate is of a slightly order of acute oral toxicity. 
 -Acute Dermal Toxicity: An LD50 value of > 2000 mg/kg was obtained. The acute lethal dermal dose was found to be greater than 2000 mg/kg.
The clipped skin on the backs of five male and five female rats were exposed to the test material under an occlusive dressing for 24 hours and observed for another 14 days. Results indicate slight erythema and slight oedema but no acute mortality. The dermal LD50 is > 2000 mg/kg. 
This show that Calcium dodecylbenzenesulphonate (the result was read across from LAS)  is not  toxic for acute Dermal toxicity .
-Acute inhalation toxicity :
Based on the study of Kinney, L. 1985, exposure of 6 male rats to Calcium dodecylbenzenesulphonate (the result was read across from Sodium dodecylbenzenesulfonate)   the LC50 was 310 mg/m3 (particulate). At 310 mg/m3 one rat died during exposure and two rats died one day post exposure. No mortality occurred at concentrations up to 260 mg/m3.(NOEC). 
Results indicate that Calcium dodecylbenzenesulphonate is not toxic for acute inhalation toxicity.
It is concluded that the substance Calcium dodecylbenzenesulphonate meet the criteria to be classified for human health hazards for acute oral effects.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

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:

other: Defined oral LD50. Adapted from appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, by the Association of Food and Drug Officials of the United States, 1965.

GLP compliance:

no

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Rat (Sprague-Dawley), weight 200-300 g.

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

Single dose by oral gavage of 1.0, 1.5, 2.0, 2.5 and 3.0 mL/kg bw.

Doses:

1.0, 1.5, 2.0, 2.5 and 3.0 mL/kg bw.

No. of animals per sex per dose:

5/sex/dose group.

Control animals:

yes

Details on study design:

Mortality/clinical signs daily for 14 days. Body weight on day 0 and 14. Macroscopy on animals that died.

Statistics:

Litchfield-Wilcoxin (Probit analysis).

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 300 mg/kg bw

Based on:

act. ingr.

Mortality:

Motaliity was not affected.

Clinical signs:

other: A high incidence of diarrhea was noted with the use of the higher concentration. Those rats which succumbed appeared to be weak and showed reduced voluntary activity prior to death.

Gross pathology:

No significant gross abnormalities were seen at autopsy.

Interpretation of results:

Category 4 based on GHS criteria

Conclusions:

The acute oral LD50 in male/female rats is 1300 mg/kg bw. No significant gross abnormalities were seen at autopsy.
LD50-rat 1.8 mL/kg ⇔ 1.3 g a.i./kg = 1300 mg/kg bw

Executive summary:

The acute oral LD50 in male/female rats is 1300 mg/kg bw. No significant gross abnormalities were seen at autopsy.

LD50-rat 1.8 mL/kg ⇔ 1.3 g a.i./kg = 1300 mg/kg bw

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 300 mg/kg bw

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

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:

Sodium dodecylbenzenesulfonate (CAS# 25155-30-0 , EC Number; 246-680-4 ) 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:

Groups of six male 8-week old rats were restrained in perforated, stainless steel cylinders with conical nose pieces. Exposure was nose-only to an aerosol atmosphere for 4 hours. After exposure, rats were returned to their cages and observed for clinical signs for 14 days. Mean measured concentrations in the test chambers were 65, 120, 260, and 310 mg/m3. Chamber temperature ranged between 25-26oC.

GLP compliance:

yes

Test type:

other: Approximate lethal concentration (ALC)

Limit test:

no

Species:

rat

Strain:

Crj: CD(SD)

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Harlan Spague-Dawley,
- Age at study initiation: 8-week old
- Housing: stainless steel cylinders with conical nose pieces.
- Acclimation period: approximately one week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 to 26
- Humidity (%): 40 to 70
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

nose only

Vehicle:

other: Exposure was nose-only to an aerosol atmosphere for 4 hours.

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
-Exposure was nose-only to an aerosol atmosphere for 4 hours.
- After exposure, rats were returned to their cages and observed for clinical signs or 14 days.
-Mean measured concentrations in the test chambers were 65, 120, 260, and 310 mg/m3.
-Chamber temperature ranged between 25-26oC.

TEST ATMOSPHERE
-Animals were given high exposures to respirable-sized particles (MMAD at 310 mg/m3 = 2.5 microns).
-Spray products containing LAS are designed to produce large particle sizes.

Analytical verification of test atmosphere concentrations:

yes

Duration of exposure:

ca. 4 h

Concentrations:

65, 120, 260, and 310 mg/m3.

No. of animals per sex per dose:

6 male 8-week old rats

Control animals:

yes

Details on study design:

-Groups of six male 8-week old rats were restrained in perforated, stainless steel cylinders with conical nose pieces.
-Exposure was nose-only to an aerosol atmosphere for 4 hours.
-After exposure, rats were returned to their cages and observed for clinical signs for 14 days.
-Mean measured concentrations in the test chambers were 65, 120, 260, and 310 mg/m3.
-Chamber temperature ranged between 25-26oC.
-Animals were given high exposures to respirable-sized particles (MMAD at 310 mg/m3 = 2.5 microns).
-Spray products containing LAS are designed to produce large particle sizes.
-These large particles are needed for efficient delivery of the spray to the surface being cleaned.

Sex:

male

Dose descriptor:

LC50

Effect level:

310 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: Approximate lethal concentration (ALC).The ALC is defined as the lowest atmospheric concentration generated that caused death in 1 or more rats either on the day of exposure or within 14 days post exposure.

Sex:

male

Dose descriptor:

other: NOEC

Effect level:

260 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: Based on No mortality occurred at concentrations up to 260 mg/m3.

Mortality:

At 310 mg/m3, one rat died during exposure and 2 rats died one day post exposure.
No mortality occurred at concentrations up to 260 mg/m3.

Clinical signs:

other: Particle sizes are much larger than the respirable particle sizes used in testing and therefore would not be able to reach far into the lungs where effects could occur.

Body weight:

During the recovery period, rats exhibited dose dependent weight loss 1 day post exposure followed by normal weight gains.

Gross pathology:

none

The ALC is defined as the lowest atmospheric concentration generated that caused death in one or more rates either on the day of exposure or within 14 days post exposure. No mortality occurred at concentrations up to 260 mg/m3. At 310 mg/m3 one rat died during exposure and two rats died one day post exposure. The test material is considered moderately toxic by inhalation. However, it is important to note that this laboratory exposure is not representative of the possible LAS exposure during actual use. In this study, animals were given high exposures to respirable-sized particles (MMAD at 310 mg/m3 = 2.5 microns). Spray products containing LAS are designed to produce large particle sizes. These large particles are needed for efficient delivery of the spray to the surfaces being cleaned. This results in particle sizes that are much larger than the respirable particle sizes used in testing and therefore would not be able to reach far into the lungs where effects would occur. Given this lack of relevance to real-world exposure potential, this use of this study beyond establishing the relative toxicity of the chemical is limited.

 

Interpretation of results:

other: not classified

Remarks:

Particle sizes are much larger than the respirable particle sizes used in testing and therefore would not be able to reach far into the lungs where effects could occur. Criteria used for interpretation of results: EU

Conclusions:

Based on this study, exposure of 6 male rats to Sodium dodecylbenzenesulfonate the LC50 was 310 mg/m3 (particulate). At 310 mg/m3 one rat died during exposure and two rats died one day post exposure. No mortality occurred at concentrations up to 260 mg/m3.(NOEC). Therefore, the health effects of Sodium dodecylbenzenesulfonate need to be considered in the assessment of Dodecylbenzenesulfonic acid.
This results in particle sizes that are much larger than the respirable particle sizes used in testing and, therefore, would not be able to reach far into the lungs where effects could occur. Given this lack of relevance to real-world exposure potential, the use of this study for risk assessment purposes is limited.
Given this lack of relevance to real-world exposure potential, the use of this acute inhalation study for risk assessment purposes is limited. Due to the irritant nature of LAS, it is expected that high LAS aerosol concentrations may be irritating to the upper respiratory tract.

Executive summary:

Based on this study, exposure of 6 male rats to Sodium dodecylbenzenesulfonate  the LC50 was310 mg/m3(particulate).At 310 mg/m3 one rat died during exposure and two rats died one day post exposure. No mortality occurred at concentrations up to 260 mg/m3.(NOEC).Therefore, the health effects of Sodium dodecylbenzenesulfonate need to be considered in the assessment of Dodecylbenzenesulfonic acid.

However, it is important to note that this laboratory exposure is not representative of the possible LAS exposure during actual use. In this study, animals were given high exposures to respirable-sized particles (MMAD at 310 mg/m3 = 2.5 microns). Spray products containing LAS are designed to produce large particle sizes. These large particles are needed for efficient delivery of the spray to the surfaces being cleaned. This results in particle sizes that are much larger than the respirable particle sizes used in testing and therefore would not be able to reach far into the lungs where effects would occur. Given this lack of relevance to real-world exposure potential, this use of this study beyond establishing the relative toxicity of the chemical is limited.

 

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

310 mg/m³ air

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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:

Benzene sulfonic acid, C10-16-alkyl derivatives (68584-22-5) 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: other:Test material was applied to shaved area of back of 6 rabbits at two doses: 2000 mg/kg (undiluted) and 212 mg/kg (2% aqueous dilution). The areas were covered with plastic and left in contact with test material for 24 hours.

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Species:

rabbit

Strain:

not specified

Sex:

not specified

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Test material was applied to shaved area of back of 6 rabbits at two doses: 2000 mg/kg (undiluted) and 212 mg/kg (2% aqueous dilution). The areas were covered with plastic and left in contact with test material for 24 hours.

Duration of exposure:

24 hr

Doses:

2000 mg/kg (undiluted) and 212 mg/kg bw (2% aqueous dilution)

No. of animals per sex per dose:

6

Control animals:

not specified

Sex:

not specified

Dose descriptor:

LD50

Effect level:

2 000 mg/kg bw

Based on:

test mat.

Remarks:

undiluted

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 212 mg/kg bw

Based on:

test mat.

Remarks:

(2% aqueous dilution)

Mortality:

All of the animals exposed to the 212 mg/kg survived.
Mortality occurred in three out of six rabbits exposed to the undiluted dose.
LD50 = 2000 mg/kg bw (undiluted); LD50 > 212 mg/kg bw (2% aqueous dilution)

Clinical signs:

other: Local skin reactions included erythema, mild edema and mild desquamation at 212 mg/kg and chemical burns, severe edema and necrosis at 2000 mg/kg. No untoward behavioral reactions were observed.

Gross pathology:

Necropsy did not reveal any gross pathological alterations.

Interpretation of results:

other: not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute lethal dermal dose was found to be 2000 mg/kg (undiluted) and LD50 > 212 mg/kg bw (2% aqueous dilution)

Executive summary:

The acute lethal dermal dose was found to be 2000 mg/kg (undiluted) and LD50 > 212 mg/kg bw (2% aqueous dilution)

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Oral toxicity

- Acute oral toxicity:LD50 in male/female rats is 1300 mg/kg bw.(Rhodia,1998).No significant gross abnormalities were seen at autopsy.This show that Calcium dodecylbenzenesulphonate is of a slightly order of acute oral toxicity.

-An acute oral toxicity study (Oser and Morgareidge, 1965) was performed for linear alkylbenzene sulphonate (LAS: nominal chain lengh of 12 carbon atoms and an average molecular weight of 346) using rats (FDRL strain, 3/sex/dose) for 14 days.10% and 40% dispersions of the LAS were prepared in distilled water and administered intragastrically. The animals were observed several times daily for behavior, appearance, and survival for a 14-day period. They were weighed initially and at 7 and 14 days. All animals that died on test as well as those sacrificed at the conclusion of the observation period were necropsied.

The acute oral LD₅₀in rats is 650 mg/kg bw. No significant gross abnormalities were seen at autopsy.

 

-An acute oral toxicity study (Hoechst AG, 1988) was performed for Calcium dodecylbenzenesulphonate as read across from Sodium dodecylbenzenesulfonate.The acute oral LD50 in male/female rats is 500-2000 mg/kg bw.No significant gross abnormalities were seen at autopsy.

 

-An acute oral toxicity study(Hempstock, C1988) was performed for Benzene sulfonic acid, C10-16-alkyl derivatives (68584-22-5) as a surrogate for Calcium dodecylbenzenesulphonate.The acute oral LD50 in male/female rats is 775 mg/kg bw. LD50 value is geometric mean between 300 and 2000 mg/kg.

-An acute oral toxicity study (Murmann, P.1984) was performed for Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts as a surrogate for Calcium dodecylbenzenesulphonate.The acute oral LD50 is 1080 mg/kg.

 

The acute oralLD₅₀in male/female rats is 650 mg/kg bw.This show that Calcium dodecylbenzenesulphonate is of a slightly order of acute oral toxicity.

 

Dermal toxicity

An LD50 value of > 2000 mg/kg was obtained.The acute lethal dermal dose was found to be greater than 2000 mg/kg.

 

The clipped skin on the backs of five male and five female rats were exposed to the test material under an occlusive dressing for 24 hours and observed for another 14 days. Results indicate slight erythema and slight oedema but no acute mortality. The dermal LD50 is > 2000 mg/kg.

This show thatCalciumdodecylbenzenesulphonate (the result was read across from LAS) is not toxic for acute Dermal toxicity .

 

Inhalation toxicity

 

Based on the study of Kinney, L. 1985, exposure of 6 male rats toCalcium dodecylbenzenesulphonate(the result was read across from Sodium dodecylbenzenesulfonate)  the LC50 was 310 mg/m3 (particulate). At 310 mg/m3 one rat died during exposure and two rats died one day post exposure. No mortality occurred at concentrations up to 260 mg/m3.(NOEC).

 

Results indicate that Calcium dodecylbenzenesulfonate is not toxic for acute inhalation toxicity .

It is concluded that the substance Calcium dodecylbenzenesulfonate meet the criteria to be classified for human health hazards for acute oral effects.

 

 

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”, according to the EU’s list of dangerous substances (OJEC No L200/130.7.99)and according to the criteria described in Directive 67/548 and in the CLP Regulation:

Directive 67/548

Very Toxic (T+) R28: Very toxic if swallowed R27: Very toxic in contact with skin R26: Very toxic by inhalation R39/26 R39/27 R39/28: Dangerous of very serious irreversible effects Toxic (T):  R25: Toxic if swallowed R24: Toxic in contact with skin R23: Toxic by inhalation R39/23 R39/24 R39/25: Danger of very serious irreversible effects Harmful (Xn): R22: Harmful if swallowed R21: Harmful in contact with skin R20: Harmful by inhalation R65: Harmful may cause lung damage if swallowed R21/22 Harmful; Harmful in contact with skin and if swallowed. R68/20 R68/21 R68/22: Possible risk of irreversible effects Other toxicological properties R67: Vapours may cause drowsiness and dizziness

CLP

H300 Acute Tox. 2 Fatal if swallowed H310 Acute Tox. 1 Fatal in contact with skin H330 Acute Tox. 2 Fatal if inhaled H370 STOT SE 1 H301 Acute Tox. 3 Toxic if swallowed H311 Acute Tox. 3 Toxic in contact with skin H331 Acute Tox. 3 Toxic if inhaled H370 STOT SE 1 H302 Acute Tox. 4 Harmful if swallowed H312 Acute Tox. 4 Harmful in contact with skin H332 Acute Tox. 4 Harmful if inhaled H304 Asp. Tox. 1 H371 STOT SE 2 (May cause damage to organs (or state all organsaffected if known) (state route of exposure if it is conclusively proventhat no other routes of exposure cause the hazard) Other toxicological properties H336 STOT SE 3 May cause drowsiness or dizziness

It is concluded that the substance Calcium dodecylbenzenesulfonate meet the criteria to be classified for human health hazards for acute oral effects:

R22: Harmful if swallowed

H302 Acute Tox. 4 Harmful if swallowed