Sodium cumenesulphonate

Endpoint summary

Description of key information

-Acute oral toxicity:. The acute oral LD50 in male/female rats is > 7000 mg/kg bw for Sodium cumenesulphonate No significant gross abnormalities were seen at autopsy.

 

 This show that Sodium cumenesulphonate is practically nontoxic for acute oral toxicity.

 

 -Acute Dermal Toxicity:

The acute lethal dermal dose was found to be greater than 2000 mg/kg.

This show that Sodium cumenesulphonate is practically nontoxic for acute dermal toxicity.

 

- Inhalatory toxicity:

The inhalatory LC50, 4h value of sodium cumenesulphonate in Albino  Wistar rats was established to exceed 770 mg/L. 

 

This show that Sodium cumenesulphonate is practically nontoxic for acute inhalation toxicity.

 

 

It is concluded that the substance sodium cumenesulphonate does not meet the criteria to be classified for human health hazards for acute oral, inhalation and dermal 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:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

CAS Number: 28348-53-0
Identity: Cumene sulfonic acid, sodium salt
Purity: 96.0%
Remarks: Substance tested is a granular solid

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen, Germany
- Age at study initiation: not mentioned
- Weight at study initiation: 141 g (males); 117 g (females), mean weights
- Fasting period before study: 16 hours
- Housing: 1 - 5 animals in Makrolon cages, type III
- Diet (e.g. ad libitum): R10 Complete feed for rats ad libitum, supplied by Ssniff Spezialfutter GmbH, Soest, Germany
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 4 - 8 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 60 ± 5
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

feeding ad libitum (food was withheld 16 hours prior to dosing).

Doses:

Single oral administration of 7000 mg/kg bw (vehicle water); no controls;
feeding ad libitum (food was withheld 16 hours prior to dosing).

No. of animals per sex per dose:

5/sex/dose group

Control animals:

no

Details on study design:

Observations:
• Mortality/clinical signs continuously for 6 hours on day 1 and daily until day 14.
• Body weights on day 1, 7 and 14.
• Necropsy on day 14 (3/sex/dose group).

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 000 mg/kg bw

Based on:

test mat.

Mortality:

male: 0/5
female 2/5

Clinical signs:

One hour after application piloerection, slight ataxia, lateral position and increased water intake was noted. After 24 hours the surviving animals were free of symptoms.

Body weight:

No effects.

Gross pathology:

Post mortem reddening of the gastric mucosa was observed, the surviving animals showed no pathological changes in organs at necropsy.

Value: Oral LD50 >7000 mg/kg bw

 

Dose [mg/kg bw] effect		7000			DR
Sex	Day	M	F	M		F
Mortality	1-14	0/5	2/5
Clinical signs(A)	1-14	+	+
Body weight	1-14	No treatment related effects
Necropsy(B)	14		+

(A)Clinical observations included increased piloerection, ataxia, lateral recumbency and

increased water intake (lasting 24 hours after dosing).

(B)In the animals that died redness of the stomach mucosa was observed.

DR is dose related. (delete this column and line; it’s not dose related since there was only

one dose.)

 

Interpretation of results:

other: practically nontoxic

Conclusions:

The acute oral LD50 in male/female rats is > 7000 mg/kg bw. No significant gross abnormalities were seen at autopsy.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

7 000 mg/kg bw

Quality of whole database:

Sufficient to meet requirements

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

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: CPSC CFR1500.40 of the Federal Hazardous Substances Act

GLP compliance:

not specified

Test type:

acute toxic class method

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- 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:

whole body

Vehicle:

air

Details on inhalation exposure:

The collected amount of the test substance in the air sample was measured gravimetrically. Sample volumes were measured by means of a dry gas meter (type G 1.6, Actaris Meterfabriek B.V., Dordrecht, The Netherlands).
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for viability were recorded once before exposure on the day of exposure (test day 1), three times during exposure, immediately and 1 h after exposure on test day 1 and twice daily during the observation period. Each animal was examined three times during exposure, immediately and 1 h after exposure on test day 1 and once daily during the observation period. Observations were detailed and carefully recorded using explicitly defined scales as appropriate. Only grossly abnormal signs were detectable during exposure as the animals were restrained in the exposure tubes. The body weight of each animal was recorded on test days 1 (before exposure), 2, 4, 8 and 15 (before necropsy).

- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Analytical verification of test atmosphere concentrations:

no

Duration of exposure:

ca. 4 h

Concentrations:

770 mg/L

No. of animals per sex per dose:

Number of Animals per Dose: 10 (5 males, 5 females)

Control animals:

yes

Details on study design:

The collected amount of the test substance in the air sample was measured gravimetrically. Sample volumes were measured by means of a dry gas meter (type G 1.6, Actaris Meterfabriek B.V., Dordrecht, The Netherlands).
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations for viability were recorded once before exposure on the day of exposure (test day 1), three times during exposure, immediately and 1 h after exposure on test day 1 and twice daily during the observation period. Each animal was examined three times during exposure, immediately and 1 h after exposure on test day 1 and once daily during the observation period. Observations were detailed and carefully recorded using explicitly defined scales as appropriate. Only grossly abnormal signs were detectable during exposure as the animals were restrained in the exposure tubes. The body weight of each animal was recorded on test days 1 (before exposure), 2, 4, 8 and 15 (before necropsy).

- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 770 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: powdered test substance

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 770 000 mg/m³ air

Based on:

test mat.

Exp. duration:

4 h

Mortality:

No mortality occurred.

Clinical signs:

other: No clinical signs were noted during exposure. After exposure, ptosis and/or piloerection were noted in two males and one female on Day 1 only.

Body weight:

Overall body weight gain in males and females was within the range expected for rats of this strain and age used in this type of study.

Gross pathology:

none

To convert mg/l into mg/m³     

1m³=1000L

        

1 mg/m³=mg/l x 1000, 770mg/l x1000=770 000 mg/m³

Interpretation of results:

other: not classified

Remarks:

practically nontoxic

Conclusions:

The inhalatory LC50, 4h value of sodium cumenesulphonate in Albino Wistar rats was established to exceed 770 mg/L.

Executive summary:

The inhalatory LC50, 4h value of sodium cumenesulphonate in Albino  Wistar rats was established to exceed 770 mg/L.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LC50

Value:

770 000 mg/m³

Quality of whole database:

Sufficient to meet requirements

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

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:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Species:

rabbit

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Not available
- Age at study initiation: Not available
- Weight at study initiation: 2703 grams (Abraded skin), 2730 grams (Intact skin)
- Fasting period before study: Not available
- Housing: Not available
- Diet (e.g. ad libitum): Not available
- Water (e.g. ad libitum): Not available
- Acclimation period: Not available

Type of coverage:

occlusive

Vehicle:

not specified

Details on dermal exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 ml/kg bw
- Concentration (if solution): Not available
- Constant volume or concentration used: yes
- For solids, paste formed: Not available


VEHICLE
- Amount(s) applied (volume or weight with unit): Not available
- Concentration (if solution): Not available
- Lot/batch no. (if required): Not available
- Purity: Not available

Duration of exposure:

24 hr

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3 male and 3 female

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Not available
- Necropsy of survivors performed: Not available
- Other examinations performed: Clinical signs, body weight

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

act. ingr.

Mortality:

No mortality was observed exposure to 2000 mg/kg of the undiluted test material.

Clinical signs:

Sodium Cumene Suphonate elicited moderate primary irritation on the test sites.

Body weight:

Normal body weight gain.

Gross pathology:

All terminal autopsy findings were normal.

Interpretation of results:

other: not classified

Remarks:

Criteria used for interpretation of results: EU

Conclusions:

The acute lethal dermal dose was found to be greater than 2000 mg/kg.This test substance is practically non toxic.

Executive summary:

The clipped skin on the backs of three male and three 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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

Sufficient to meet requirements

Justification for classification or non-classification

Based on the hazard assessment of Sodium cumenesulphonate, 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”, 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 sodium cumenesulphonate does not meet the criteria to be classified for human health hazards for acute oral, inhalation and dermal effects.