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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

 

 

 

 

 

 

 

 

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