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Description of key information

-The acute eye irritation study (Rhodia,1998)  indicates that Calcium dodecylbenzenesulfonate caused irritation. 
Result: irritating at 0.1 mL.
- The results of the study study (Rhodia,1998) indicate that Calcium dodecylbenzenesulfonate is irritant to skin 0.5 mL according to OECD GHS guidelines.
Result: irritant 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:
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:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst AG
- Age at study initiation: 3-5 months
- Weight at study initiation: 2.6-3.5 kg
- Housing: individual cages, identified with ear tags
- Diet (e.g. ad libitum): Altromin 2123 Haltungsdiat ad libitum, 15 g/day
- Water (e.g. ad libitum): deionized water ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 degree C
- Humidity (%): 50 +/- 20 %
- Photoperiod (hrs dark / hrs light): 12/12 hrs
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
4 hrs
Observation period:
Observations were made at 30-60 minutes, and 24, 48, and 72 hrs after end of exposure. If adverse effects had not resolved by the 72 hr observation, additional observations were made at 7, 14, and 21 days after end of exposure.
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: dorsal trunk area
- % coverage: 2.5 x 2.5 cm area
- Type of wrap if used: cellulose bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): removed with lukewarm water
- Time after start of exposure: 4 hrs

SCORING SYSTEM: Draize scale
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2.7
Max. score:
3
Reversibility:
fully reversible within: 7 days
Remarks on result:
other: Though erythema cleared by 7 days, it reappeared at 14 days.
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.8
Max. score:
2
Reversibility:
fully reversible within: 7 days
Irritant / corrosive response data:
From 1 to 72 hrs after end of exposure , animals showed mild to severe erythema, and mild to moderate edema. At the 7 day observation, there was on edema or erythema. However, at the 14 day observation, there was mild to moderate erythema, and the skin was raised, inflexible, and dry. At the 21 day oberservation, there was thickening of the epidermis, but a clearing of the erythema.
Other effects:
Microscopic examination showed hardening of the skin, hyperkeratosis, and misalignment with nearby skin.

Skin Irritation in Rabbits

Animal

Observation

Erythema and Scabbing

Edema

1

0.5-1 hr

1

3

24 hrs

2

2

48 hrs

2

1

72 hrs

3

1

7 days

0

0

14 days

1

0

21 days

Clearing of thickening and redness

-

2

0.5-1 hr

1

3

24 hrs

2

2

48 hrs

3

2

72 hrs

3

2

7 days

0

0

14 days

2

0

21 days

Clearing of thickening and redness

-

3

0.5-1 hr

2

3

24 hrs

3

2

48 hrs

3

2

72 hrs

3

2

7 days

0

0

14 days

3

0

21 days

Clearing of thickening and redness

 

 

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test substance is irritating to skin according to the DSD and CLP.
Executive summary:

Three female rabbits were exposed to 0.5 ml of test substance on the dorsal area of the trunk for four hours. After four hours, the test substance was removed by washing with lukewarm water. Observations for erythema and edema were made 0.5 -1, 24, 48, and 72 hrs. Since adverse effects were not fully resolved by the 72 hr observation, further observations were made at 7, 14, and 21 days. Mild to moderately severe edema and erythema were noted at the 1, 24, 48, and 72 hr observations. Erythema and edema cleared by the 7 day observation, but the erythema returned by the 14 day observation. This was clearing by the 21 day observation. The test substance is classified as a Category 2 irritant according to EU DSD and CLP guidelines.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Eye irritation

Link to relevant study records
Reference
Endpoint:
eye irritation: in vivo
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:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
not specified
Species:
rabbit
Strain:
other: New Zealand
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 ml
- Concentration (if solution): 100%
Duration of treatment / exposure:
24 hrs
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hrs
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
24 h
Score:
> 1 - < 3
Remarks on result:
other: May cause serious damage to eyes
Interpretation of results:
other: irritating
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
The test substance is classified as R41, may cause serious damage to eyes, under the DSD.
Executive summary:

Rabbits were exposed to 0.1 ml of 100% test substance in the eye for 24 hrs. Results show that the test substance may cause serious damage to the eyes.

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 (Rhodia,1998) indicates that Calcium dodecylbenzenesulfonate caused irritation.

Result: irritating at 0.1 mL.

 

-The acute eye irritation study (Murmann, P.1984) indicates that Calcium 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 %.

 

Basedon the descriptions of the lesions it is considered that Carlium dodecylbenzenesulfonate  is classifiable as a irritant according to EU criteria.

 

 Skin irritation

- The results of the study study(Rhodia,1998)indicate that Calcium dodecylbenzenesulfonate is irritantto skin 0.5 mL according to OECD GHS guidelines.

Result: irritant to skin at 0.5 mL

 

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

Result:irritantto skin at 0.5 mL

 

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

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

Result:irritant 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 Calcium dodecylbenzenesulfonate is classifiable as irritant to skin according to EU criteria

 

Respiratory irritation.

Based on the study of Kinney, L.1985, exposure of 6 male rats to Calcium dodecylbenzenesulfonate (the result was read across from 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).

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: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Based on the hazard assessment of Calcium dodecylbenzenesulfonate in section 2.1 and 2.2. in IUCLID 6., 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  Calcium 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 Calcium 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 Calcium dodecylbenzenesulfonate does not meet the criteria to be classified for human health hazards for respiratory irritation

 

 

 

 

 

 

 

 

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