Sodium dodecylbenzenesulfonate

Endpoint summary

Description of key information

-The acute eye irritation study (Murmann, P.1984) indicates that Sodium dodecylbenzenesulfonate (the result was read across from Benzenesulfonic acid, C10-13-alkyl derivatives (85536-14-7))  caused moderate irritation. 
Result: moderately irritating at 0.1 mL.
- The results of the study (Thompson, G.W. 1980) indicate that Sodium dodecylbenzenesulfonate (the result was read across from Dodecylbenzenesulfonic acid CAS# 27176-87-0) is corrosive to skin 0.5 mL according to OECD GHS guidelines. 
Result: corrosive to skin at 0.5 mL
 -Based on the study of Kinney, L.1985, not Respiratory irritation was observed. There were no treatment-related changes in the haematological or urinalysis values in any of the animals.No signs of irritation of respiratory tract and Nasal effects were observed

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

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

Justification for type of information:

Dodecylbenzene sulfonic acids (CAS# 27176-87-0 , EC Number; 248-289-4) ) is a very close analogue of Sodium dodecylbenzenesulfonate (CAS No. 25155-30-0, EC Number; 246-680-4) ) and the dissociated acid it readily dissociates in water and release the dodecylbenzene sulfonic anion in solution.

Qualifier:

according to guideline

Guideline:

other: Draize Test 1965

Principles of method if other than guideline:

The test material was applied as submitted to the intact skin and covered with a "1 x 1" gauze patch held in place with saran wrap. At the end of 4 hours, the coverings were removed and the area examined for skin irritation and corrosion. Examinations were repeated at 24 and 48 hours and scored according to Draize 1965.

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

Male and female white New Zealand rabbits weight between 4 and 5.6 kg each. Animals were marked with a 5 digit number and held in steel cages. They were acclimated for 14 days prior to testing. Standard rabbit diet and water was provided ad libitum. Room temperature was held at 20 degrees C +/- 1 degree C, humidity at 60 +/- 5%, with a 12/12 hour light/dark cycle.

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not specified

Amount / concentration applied:

0.5 mL

Duration of treatment / exposure:

4 hours

Observation period:

Observations were made after 4, 24, and 48 hours,

Number of animals:

6 (3 male, 3 female)

Details on study design:

The test material was applied as submitted to the intact skin and covered with a "1 x 1" gauze patch held in place with saran wrap. At the end of 4 hours, the coverings were removed and the area examined for skin irritation and corrosion. Examinations were repeated at 24 and 48 hours and scored according to Draize 1965.

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 4 hours

Score:

3.4

Reversibility:

not reversible

Remarks on result:

other: highly irritating

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 24 hours

Score:

6.3

Reversibility:

not reversible

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: 48 hours

Score:

7

Reversibility:

not reversible

Interpretation of results:

Category 1C (corrosive) based on GHS criteria

Conclusions:

Result: corrosive
EC Classification: irritating at 0.5 mL

Executive summary:

The test material was applied as submitted to the intact skin and covered with a "1 x 1" gauze patch held in place with saran wrap. At the end of 4 hours, the coverings were removed and the area examined for skin irritation and corrosion. Examinations were repeated at 24 and 48 hours and scored according to Draize 1965 The primary dermal irritation scores were 3.4, 6.3, and 7.0 at 4, 24, and 48 hours, respectively.

The test substance is considered corrosive to skin according to OECD GHS guidelines.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (corrosive)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

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 405 (Acute Eye Irritation / Corrosion)

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

Male and female white New Zealand rabbits weight between 3.7 and 6.0 kg each. Animals were marked with a 5 digit number and held in steel cages. They were acclimated for 14 days prior to testing. Standard rabbit diet and water was provided ad libitum. Room temperature was held at 20 degrees C +/- 1 degree C, humidity at 60 +/- 5%, with a 12/12 hour light/dark cycle.

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.1 mL

Duration of treatment / exposure:

Single treatment that was not washed out.

Observation period (in vivo):

1, 24, 48, and 72 hours and at 6 days after application.

Number of animals or in vitro replicates:

6 (3 male, 3 female)

Details on study design:

Treatment was to the right eye with lower lid removed. The left eye was untreated and served as the control. The eyes were not washed out during the test. Observations were made at 1, 24, 48, and 72 hours and at 6 days after application.

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 1, 24, 48, and 72 hrs and 6 days

Score:

46.9

Reversibility:

not fully reversible within: 6 days

Remarks on result:

other: moderately irritating

Irritant / corrosive response data:

Results indicated a moderate irritancy, but because of the intensity of the necrosis formation, the study was stopped at day 6.

Treatment was to the right eye with lower lid removed. The left eye was untreated. The eyes were not washed out duringthe test. Observations were made at 1, 24, 48, and 72 hours and at 6 days after application. The total irritation index was 46.9.

Interpretation of results:

other: moderately irritating

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

Result: moderately irritating at 0.1 mL.

Executive summary:

The eyes of six rabbits were treated with the test substance and observed for six days. Results indicate that the substance was moderately irritating but because of the intensity of the necrosis formation the study was stopped at day 6.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Additional information

Eye irritation

 

-The acute eye irritation study (Murmann, P.1984) indicates that Sodium dodecylbenzenesulfonate (the result was read across from Benzenesulfonic acid, C10-13-alkyl derivatives (85536-14-7)) caused moderate irritation.

 

Result: moderately irritating at 0.1 mL.

 

The study (Liggett, M.P. and Parcell, B.I. 1986), performed according to OECD Guidelines, was conducted on three rabbits with LAS(as a read across)at 47%. Groups of three rabbits had 0.1 ml of test substance placed in each of their eyes. In one group, the eyes were not rinsed. In the second group, the eyes were rinsed after 4 seconds of exposure. In the third group, the eyes were rinsed after 30 seconds of exposure. Observations were made one hour and 1, 2, 3, 4, 7, 14, and 21 days after exposure. Severe irritation was noted in the animals whose eyes were not rinsed. This irritation was not resolved in one of these animals at the end of 21 days. Irritation was also seen in the animals rinsed after 30 seconds, although the irritation was not as severe, and the effects were fully reversible within 14 days. Mild irritation was seen in the animals rinsed after 4 seconds. These effects were fully reversible within 7 days. Since OECD guideline 405 for eye irritation studies calls for an exposure of at least 24 hrs, the results for unrinsed eyes were used for classification. According to these results, the test substance is a category 1 eye irritant because it caused damage that was not reversible within 21 days.

Result: irritating at 0.1 mL.

 

Based on the study of Limori et al., 1972 of eye irritation test, it is concluded that the substance LAS at low concentration of level used as detergent have not any permanent lesion, and the recovery of symptoms showed at high concentration are relatively quick.

Result: not irritating to eye at 1.5 %.

 

Based on the descriptions of the lesions it is considered that Sodium dodecylbenzenesulfonate (the result was read across from Benzenesulfonic acid, C10-13-alkyl derivatives (85536-14-7) is classifiable as a moderately irritantaccording to EU criteria.

 

 Skin irritation

The results of the study (Thompson, G.W. 1980) indicate that Sodium dodecylbenzenesulfonate (the result was read across from Dodecylbenzenesulfonic acidCAS# 27176-87-0) is corrosive to skin 0.5 mL according to OECD GHS guidelines.

Result:corrosive to skin at 0.5 mL

 

The results of the study (Murmann, P. 1984) indicate that Sodium dodecylbenzenesulfonate (the result was read across from Benzenesulfonic acid, C10-13-alkyl derivatives (85536-14-7 is corrosive to skin 0.5 mL according to OECD GHS guidelines.

The test substance is considered corrosive to skin according to OECD GHS guidelinesat 0.5 mL .

Result:corrosive to skin at 0.5 mL

 

The results of thestudy (Misraet al., 1989) Linear alkyl benzene sulfonate (1% neutralized LAS solution) was slightly irritating to the skin. Guinea-pig skin after 7 days exposure to LAS appeared shrunken, with thin layers of dermis and epidermis of guinea pigs in the histologic sections compared to controls.

Result:slightly irritating to the skin.

 

The results of the study (Liggett, M.P. and Parcell, B.I. 1986) the test substance was moderately to severely irritating to skin, but effects were not fully reversible within 14 days. The test substance is a Category 2 irritant according to EU GHS guidelines based on persistent irritation.

Result: irritating to the skin at 0.5 mL

 

Based on the descriptions of the lesions it is considered that Sodium dodecylbenzenesulfonateis classifiable as a corrosive to skin according to EU criteria

 

Respiratory irritation.

Based on the study of Kinney, L.1985, exposure of 6 male rats toSodium 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).

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.

 

Based on the study of Kinney, L.1985,not Respiratory irritation was observed.

There were no treatment-related changes in the haematological or urinalysis values in any of the animals. No signs of irritation of respiratory tract and Nasal effects were observed

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: moderately irritating

Justification for classification or non-classification

Based on the hazard assessment of Sodium 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

Skin Corrosivity C R35 Causes severe burns R34 Causes burns Skin Irritation Xi R38 Irritating to skin R43 May cause sensitization by skin contact Eye Irritation (Ocular Lesions) Xi R36 Irritating to eyes R37 irritating to respiratory system R41 Risk of serious damage to eyes

CLP

Skin Corrosivity  H314 Skin Corr 1A Causes severe skin burns and eye damage H314 Skin Corr 1B Causes severe skin burns and eye damage Skin Irritation  H315 Skin Irrit. 2 Causes skin irritation H317 Skin Sens. 1 May cause an allergic skin reaction Eye Irritation (Ocular Lesions) Xi H319 Eye Irrit. 2 Causes serious eye irritation H318 Eye Dam. 1 Causes serious eye damage H335 STOT SE 3 May cause respiratory irritation

 

It is concluded that the substance  Sodium dodecylbenzenesulfonate meet the criteria to be classified for human health hazards for Dermal-local effect:

R38 - Irritating to skin

R41 Risk of serious damage to eyes,

H315: Causes skin irritation

H318: Causes serious eye damage.

 

It is concluded that the substance Sodium dodecylbenzenesulfonate meet the criteria to be classified for human health hazards for Dermal-local effect :R38 - Irritating to skin, R41 Risk of serious damage to eyes, H315: Causes skin irritationSkin Irrit. 2 ,H318: Causes serious eye damage, Eye Damage 1.

 

 

It is concluded that the substance Sodium dodecylbenzenesulfonate does not meet the criteria to be classified for human health hazards for respiratory irritation