Benzene, mono-C10-13-alkyl derivs., distn. residues, sulfonated, barium salts

Endpoint summary

Description of key information

Acute oral toxicity: LD50 of greater than 5,000 mg/kg bw (5,000- 20,000 mg/kg bw) were established for rats for acute oral toxicity for the read-across substances calcium benzene sulfonates in all available studies.
Acute dermal toxicity: LD50 of greater than 2000 mg/kg bw for rats was established in a limit test for acute dermal toxicity for the read-across substances calcium benzene sulfonates in all available studies

Acute inhalation toxicity: LC50 of greater than 1900 mg/m³, the maximum attainable aerosol concentration, was established for the read-across substances calcium benzene sulfonate in an inhalation study with CAS 61789 -86 -4.

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

Study period:

Between 28 February 1972 and 21 March 1972

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study not conducted to guidelines or GLP.

Qualifier:

no guideline followed

Principles of method if other than guideline:

Adult albino male Sprague-Dawley rats were fasted for 24 hours, then given a single dose and placed in screen bottom cages with free access to water and laboratory chow for a two week observation period.

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

maximum dose volume applied: 20000 mg/kg bw

Doses:

5000, 10000, 20000 mg/kg bw

No. of animals per sex per dose:

6 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days

Statistics:

Use of statistics not indicated.

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 000 - < 20 000 mg/kg bw

Remarks on result:

other: 95% CL not indicated

Mortality:

5/6 males died on the third day following dosing in the 20000 mg/kg bw group.

Clinical signs:

No data.

Body weight:

No data.

Gross pathology:

No data.

Table 2: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

 

Dose (mg/kg bw)	Mortality (# dead/total)			Time range of deaths (hours)	Number with evident toxicity (#/total)
	Male	Female	Combined		Male	Female	Combined
5000	0/6	0/6	0/6		unknown	unknown	unknown
10000	0/6	0/0	0/6		unknown	unknown	unknown
20000	5/6	0/0	0/6	72	unknown	unknown	unknown

Interpretation of results:

other: EU-GHS criteria not met

Conclusions:

Mortality occurred at 20000 mg/kg bw. The LD50 is considered to be between 10000 and 20000 mg/kg bw but has not been determined precisely.

Executive summary:

In an acute oral toxicity study, groups of Sprague-Dawley rats (6 males) were given a single oral dose of C14-24 alkaryl calcium salt derivatives (CAS 70024 -69 -0) at 5,000, 10,000 or 20,000 mg/kg bw and observed for 14 days. Mortality occurred at 20,000 mg/kg bw, therefore the LD50 is considered to be between 10,000 and 20,000 mg/kg bw.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

10 000 mg/kg bw

Quality of whole database:

High quality since numerous reliable studies are available.

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1986-10-08 to 1986-10-22

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Qualifier:

according to guideline

Guideline:

EPA OPP 81-3 (Acute inhalation toxicity)

Deviations:

yes

Remarks:

male animals slightly younger than specified in the protocol

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc. Kingston, New York 12484
- Age at study initiation: nine to twelve weeks old
- Weight at study initiation: 194g to 232g.
- Fasting period before study: Not applicable
- Housing: Animals were doubly-housed in suspended stainless steel wire mesh cages during the first week of the acclimation period and individually during the remainder of the acclimation period and all other non-exposure periods
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: eight days

ENVIRONMENTAL CONDITIONS
- Temperature: 67-76°F
- Humidity: 30-70%
- Photoperiod (hrs dark / hrs light): twelve hours continuous light and twelve hours darkness

IN-LIFE DATES: From: 08 October 1986 To: 22 October 1986

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

other: unchanged (no vehicle)

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Approximately 410 mL of test material was placed into a 500 mL Erlenmeyer flask and connected to an FMI fluid metering pump (Model #RPG-20) with a 1/4" piston, plus exposure chamber
- Exposure chamber volume: approximately 100 litres
- Method of holding animals in test chamber: Animals were individually housed in a 100 liter Plexiglas exposure chamber.
- Source and rate of air: House-supply air was delivered through 1/4" Tygonm tubing, a Nupro metering valve and a Union Carbide pressure gauge (at a constant backpressure of 25 pounds per square inch, psi) to a 0-20 lpm Dwyer flowmeter at a calibrated flow rate of 20.1 lpm into the air inlet of the atomizer to generate the aerosol.
- Method of conditioning air: None described
- System of generating particulates: Erlenmeyer flask and connected to an FMI fluid metering pump (Model #RPG-20) with a 1/4" piston
- Method of particle size determination: Marple Personal Cascade Impactor (Westech IS Ltd, Beds., UK).
- Treatment of exhaust air: None specified
- Temperature and humidity: An Airguide humidity indicator was used to continuously monitor relative humidity and a Taylor thermometer was used to continuously monitor air temperature in the exposure chamber. Recordings of temperature, relative humidity and air flow rate readings were made every 1/2 hour during exposure.

TEST ATMOSPHERE
- Brief description of analytical method used: Samples for determination o f the exposure level were drawn from the exposure chamber using Whatman glass microfibre filter paper (Type GF/F, 3.7 cm) mounted in a Gelman gravimetric filter holder. Samples were withdrawn for 4 minutes at an airflow rate of 1 lpm, once per hour from the normal sampling portal and once during exposure from the distribution sampling portal.

- Samples taken from breathing zone: Yes

VEHICLE
- Composition of vehicle (if applicable): Not applicable
- Concentration of test material in vehicle: Not applicable
- Justification of choice of vehicle: Not applicable
- Lot/batch no. (if required): Not applicable
- Purity: Not applicable
- MMAD (Mass median aerodynamic diameter: 9.93 µm

CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: Not applicable.

Analytical verification of test atmosphere concentrations:

no

Remarks:

Gravimetric only

Duration of exposure:

4 h

Concentrations:

Mean Maximum Attainable (mg/L) 1.9
Nominal Concentration (mg/L) 41
Mean Mass Median Aerodynamic Diameter (µm) 4.2
Inhalable Fraction (% <10 µm) 93
Geometric Standard Deviation 1.9

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Day 1 (Day of Exposure) - All animals were observed individually, immediately prior to exposure, as a group at approximately fifteen-minute intervals during the first hour of exposure and hourly for the remainder of the exposure period. All animals were observed individually upon removal from the chamber (half-hour after exposure was completed) and hourly for two hours post-exposure. Detailed physical observations were recorded at each interval. Days 2 through 15 (Post-exposure) Detailed observations were recorded for animals once daily; viability was assessed twice daily.
Individual bodyweights Day 1 (immediately prior to exposure) and on Days 2, 3, 5, 8 and 15 (just prior to sacrifice).
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs.
Postmortem: A complete gross postmortem examination was performed on all animals sacrificed at the end of the 14-day post-exposure observation period. The gross postmortem examinations included examination of the nasal passages, trachea, external surface, all orifices, the cranial cavity , carcass, the brain and spinal cord, the thoracic, abdominal and pelvic cavities and their viscera, and the cervical tissues and organs.
Method of Sacrifice: Exsanguination while under ether anesthesia.

Statistics:

Data evaluations included the relationship, if any, between the animals’ exposure to the test material and the incidence and severity of all abnormalities including behavioural and clinical observations, necropsy findings, bodyweight changes, mortality and any other toxicological effects. Using the mortality data obtained, an estimate of the acute inhalation median lethal concentration (LC50) of the test material was made.

Preliminary study:

Not applicable

Sex:

male/female

Dose descriptor:

LC50

Effect level:

> 1.9 mg/L air

Based on:

test mat.

Exp. duration:

4 h

Remarks on result:

other: CL not given

Remarks:

No mortality was observed. Signs of treatment included reduced activity and laboured breathing during the exposure. Signs of treatment such as secretory signs and matted coats persisted during the first week after exposure, but generally abated before the day 15 sacrifice. A minimal, transient adverse effect upon body weight was produced by treatment. Otherwise bodyweight values were considered unremarkable. Gross postmortem observations were considered unremarkable.

Mortality:

All animals survived the duration of the study.

Clinical signs:

other: Observations noted during exposure included reduced activity, closed eyes and a few animals with laboured breathing towards exposure completion. Signs exhibited by animals upon removal from the chamber and during the two-hour post-exposure observation per

Body weight:

Test Week 1: body weights were slightly less than pretest values in some animals. This was considered a minimal response to exposure.
Test Week 2: body weights were considered unremarkable.

Gross pathology:

No gross effects of the test material were observed.

Other findings:

Not applicable.

Interpretation of results:

other: EU-GHS criteria not met

Conclusions:

Ten of ten CD (Sprague-Dawley derived) rats receiving a single four-hour exposure to 1.9 mg/L of the calcium sulfonate (CAS 61789-8-4) (product as manufactured diluted to 65% in mineral oil) as a maximum attainable respirable aerosol, survived until sacrifice on day 15. Signs of treatment included reduced activity and laboured breathing during the exposure. Signs of treatment such as secretory signs and matted coats persisted during the first week after exposure, but generally abated before the day 15 sacrifice. A minimal, transient adverse effect upon body weight was produced by treatment. Otherwise bodyweight values were considered unremarkable. Gross postmortem observations were considered unremarkable.

Executive summary:

The acute inhalation toxicity of the calcium sulfonate read across substance (CAS 61789-86-4, product as manufactured diluted in mineral oil (65/35)) was investigated in CD (Spraque-Dayley derived) rats according to EPA OPP 81-3 (Acute inhalation toxicity). The substance (1.9 mg/L as maximum attainable respirable aerosol) was administered for 4 hours (whole-body exposure) into the breathing zone of the animals (5 male and 5 female rats) as an aerosol. The animals were observed for additional 14 days after exposure. The mean achieved atmosphere concentration was 1.9 mg/L (nominal atmosphere concentration 41 mg/L). The mean mass median aerodynamic diameter was 4.2 µm, and the inhalable fraction (< 10 µm) was 93 %. Clinical signs and mortality rates were determined at approximately fifteen-minute intervals during the first hour of exposure and hourly for the remainder of the exposure period. All animals were observed individually upon removal from the chamber (half-hour after exposure was completed) and hourly for two hours post-exposure. Detailed physical observations were recorded at each interval. During days 2 - 15 (post-exposure), detailed observations were recorded for animals once daily; viability was assessed twice daily. The animals were sacrificed at the end of the study, dissected and examined macroscopically. The symptoms in this group were reduced activity, closed eyes and in a few animals laboured breathing towards exposure completion. Signs exhibited by animals upon removal from the chamber and during the two-hour-post exposure observation period on day 1 included secretory signs, some respiratory signs, hunched appearance and matted coats. During test week 1, test animals exhibited decreasing signs of treament such as secretory signs and matted coat. These signs mostly abated by day 8 and during test week 2, animals exhibited few continuing signs of treatment.

No animal died (mortality 0 %). The body weights of the animals were slightly less than pretest values after test week 1. This was considered a minimal response to exposure, because in test week 2 the body weights were considered unremarkable. The gross pathology did not reveal effects of the test material. Therefore the LC50 values is > 1.9 mg/L.

Endpoint conclusion

Endpoint conclusion:

no study available

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:

other: Study conducted to OECD Guidelines and to GLP, but not fully reported.

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

Approximately 24 hour prior to topical application of the test material, the hair of each control and treated animal was closely clipped.
A single dose of 2000 mg/kg of the undiluted test material was administered dermally to five male and female animals.

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Dose level: 2 g/kg
Dose volume not specified

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: On day of dosing and day 7 and 14 following dosing.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs observed each day

Statistics:

None, there was no mortality.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: 95% CL not indicated. LD50 is greater than 2000 mg/kg bw.

Mortality:

Mortality did not occur in treated animals.

Clinical signs:

No clinical signs of toxicity were observed in treated animals.

Body weight:

Significant decreases in bodyweight were observed in treated males on days 2, 7 and 14.

Gross pathology:

Skin irritation was observed for all treated animals. Multiple pinpoint scabs were observed in 3 treated males and 1 treated female.

Table 2: Number of animals dead [and with evident toxicity] [and time range within which mortality occurred]

Dose (mg/kg bw)	Conc. in vehicle (%)*	Mortality (# dead/total)			Time range of deaths (hours)	Number with evident toxicity (#/total)
		Male	Female	Combined		Male	Female	Combined
Control		0/5	0/5	0/10		0/5	0/5	0/10
2000		0/5	0/5	0/10		5/5	5/5	10/10

No signs of systemic toxicity were observed. All treated animals exhibited skin irritation. Significant differences in mean body weight were observed between treated and control males on days 2, 7 and 14. At necropsy, multiple pinpoint scabs were observed in three treated males and one treated female.

Interpretation of results:

other: EU-GHS criteria not met

Conclusions:

No mortality occurred at a maximum tested level of 2000 mg/kg bw and the study has been completed as a limit test. The LD50 is considered to be more than 2000 mg/kg.

Executive summary:

In an acute dermal toxicity study, groups of Sprague-Dawley rats (5/sex) were given a single dermal dose of the calcium sulfonate substance (Analogue of CAS 70024 -69 -0), at 2000 mg/kg bw and observed for 14 days. No mortality occurred in this limit test; therefore an exact LD50 has not been determined. The test article (Analogue of CAS 70024 -69-0), when administered dermally as received to 5 male and 5 female Sprague Dawley rats had an acute dermal LD50 of greater than 2.0 g/kg. No evidence of systemic toxicity was observed.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Quality of whole database:

High quality since several reliable studies are available.

Additional information

There are no acute studies available for Benzene, mono-C10-13-alkyl derivs., distn. residues, sulfonated, barium salts. Therefore, results of acute studies of structurally similar read-across substances calcium sulfonates are used to assess acute toxicity potential of the target substance.

Acute oral toxicity data of read across substances:

In the key acute oral toxicity study (Swan, 1972), Sprague-Dawley rats (6 males) were given a single oral dose of the calcium sulfonate read across substance (CAS 70024 -69 -0) at doses of 5000, 10000 or 20000 mg/kg bw. Thereafter, the animals were observed for 14 days. Mortality occurred only at 20,000 mg/kg dose group. Therefore, the LD50 value is between 10,000 and 20,000 mg/kg bw.

A number of supporting acute oral toxicity studies with calcium sulfonate read across substances in rats also revealed that the LD50 values are above the limit for classification.

In one supporting acute oral toxicity study (Sanitised, F., 1989), Sprague-Dawley rats (5/sex/dose) were given a single oral dose (5000 mg/kg bw) of the calcium sulfonate read across substance (Analogue of 70024-69-0). Thereafter the animals were observed for 14 days. No mortality occurred in this limit test, therefore the LD50 is above 5,000 mg/kg bw.

Furthermore, another supporting study investigating the acute oral toxicity of the calcium sulfonate read across substance (CAS 115733 -09 -0) is available (Sanitised, A., 1981). In this study, Sprague-Dawley rats (5/sex/dose) were given a single oral dose of 5000 mg/kg bw. Thereafter the animals were observed for 14 days. No mortality occurred in this limit test, therefore the LD50 is above 5,000 mg/kg bw.

In another acute oral toxicity study (Sanitised, C., 1984) to assess the acute oral toxicity of the calcium read across substance (CAS 68783-96-0), groups of Sprague-Dawley rats (5/sex/dose) were given a single oral dose of the test item at 5,000 mg/kg bw and observed for 14 days. No mortality occurred in this limit test, therefore an LD50 has not been determined. The calcium sulfonate test article, when administered as received to 5 male and 5 female Sprague-Dawley rats, had an acute oral LD50 of greater than 5,000 mg/kg.

Considering the acute oral toxicity study (Sanitised, E., 1985), groups of Sprague-Dawley rats (5/sex/dose) were given a single oral dose of the calcium read across substance (CAS 61789-86-4) at doses of 0 or 5000 mg/kg bw and observed for 14 days. No mortality occurred in this limit test, therefore the LD50 has not been determined. The test article, when administered in peanut oil to 5 male and 5 female Sprague-Dawley rats, had an acute oral LD50 of greater than 5;000 mg/kg.

In another supporting study referring to the acute oral toxicity (Ohees, 1968a) adult albino male rats of the Sprague-Dawley strain, 200 - 300 grams in weight, were treated with the calcium read across substance (CAS 61789-86-4) for the evaluation of the acute oral toxicity. The animals were given a single calculated dose and observed for a two week period at the dosage levels of 5,000 mg/kg, 10,000 mg/kg and 20,000 mg/kg. A LD50 in excess of 20,000 mg/kg of body weight was found.

In another supporting study (Regel, 1970), the acute oral toxicity of the calcium sulfonate read across substance (CAS 61789-86-4) was assessed. Adult albino male rats of the Sprague-Dawley strain were given single calculated doses (5,000 mg/kg and 10,000 mg/kg) of the test item and observed for a two week period. Under the specified test conditions the substance has an estimated oral LD50 in excess of 10,000 mg/kg bw.

Referring to an additional supporting study (Ohees, 1968b), adult albino male rats of the Sprague-Dawley strain, 200-300 grams in weight, were treated with the calcium sulfonate read across substance (CAS 61789-86-4) to identify the acute oral toxicity. The animals were given a single calculated dose via stomach tube syringe and observed for a two week period. The concentration of test material was 50% in corn oil. The number of animals used per dose was 6 males (at a dose of 5,000 mg/kg), 2 males (at a dose of 10,000 mg/kg) and 2 males (at a dose of 20,000 mg/kg). Under the conditions specified the test substance has an estimated oral LD 50 in excess of 20,000 mg/kg bw.

In addition to the above mentioned studies, another supporting study is given for this endpoint. In order to investigate the acute oral toxicity of the calcium sulfonate read across substance (CAS 61789-86-4) in rats (Gabriel, 1981), five groups of five male albino rats of the Sherman-Wistar strain weighing between 200 and 300 grams were treated with The following dosage levels were administered: 1,000, 2,000, 4,000, 8,000 mg/kg and 16,000 mg/kg. Therefore, the LD50 is greater than 16,000 mg/kg.

In accordance with EU CLP (Regulation (EC) No. 1272/2008), classification is not required for acute oral toxicity or specific target organ effects.

Acute dermal toxicity data of read across substances:

In the key acute dermal toxicity study (Sanitised, G., 1989), groups of Sprague-Dawley rats (5/sex) were given a single dermal dose of the calcium sulfonate read across substance, (Analogue of CAS 70024-69-0), at 2,000 mg/kg bw and observed for 14 days. No mortality occurred in this limit test. The acute dermal LD50 was greater than 2,000 mg/kg. No evidence of systemic toxicity was observed.

In a supporting study, the acute dermal toxicity of another calcium sulfonate read across substance (CAS 115733-09-0) was investigated in male and female New Zealand white rabbits (5/sex) were treated with a single dose of 5,000 mg/kg bw dermally for 24 h and observed for 14 days (Sanitised, B., 1981). As no mortality occurred, this study also showed the LD50 value > 5,000 mg/kg bw and thereby to be above the limit for classification (Sanitised, B., 1981).

In another supporting study, the acute dermal toxicity of the calcium sulfonate read across substance (CAS 61789-86-4) was investigated in New Zealand White rabbits (Costello, 1986a). The calcium sulfonate test article was dosed as supplied, at a dose level of 4,000 mg/kg for 24 hours. A group of 10 rabbits (5 males & 5 females) with healthy intact skin was used. The treated area was covered with a large porous gauze patch. The dressings were removed after 24 hours and any excess material removed, where practical, using water or an appropriate solvent. The animals were observed for a 14 day period for signs of toxicity (systemic and topical) and for mortalities. In males the symptoms after removal of the substance and the patch were mild erythema and mild to severe oedema.  At 7 days mild to moderate erythema and slight to severe oedema were noted. Dry flaking skin was noted for 2/5 animals at 9 days and for 1/5 animals at 13 days. At 14 days slight to mild skin irritation was noted. However, all animals appeared normal throughout the 14 day observation period. In females the symptoms were the same, with the following derivations: Mild to moderate erythema and mild to severe oedema after 24 hours. Dry flaking skin was noted for 2/5 animals at 9 days. At 14 days mild to moderate skin irritation was noted. The death of 1/5 animals on day 9 was not preceded by any adverse symptoms. A lack of faecal material in the cage pan on days 9 through 11 and signs of dehydration on days 10 and 11 were noted for 1/5 animals. Other than the above observations all animals appeared normal throughout the 14 day observation period. The body weights of the animals were not influenced. The gross pathology did not reveal effects of the calcium sulfonate test material. In conclusion, the calcium sulfonate test article (CAS 61789 -86 -4) when dosed as supplied appears to have an acute dermal LD50 greater than 4.0 g/kg (4,000 mg/kg bw, respectively).

Furthermore, in an additional supporting study (Sanitised, J., 1993) to investigate the acute dermal toxicity, groups of New Zealand White rabbits (5/sex) were given a single dermal dose of the calcium sulfonate read across substance (CAS 68783-96-0) at 2,000 mg/kg bw and observed for 14 days. No mortality occurred in this limit test; therefore an LD50 has not been determined. The calcium sulfonate test article, when administered dermally as received to 5 male and 5 female New Zealand White rabbits had an acute dermal LD50 of greater than 2,000 mg/kg. No evidence of systemic toxicity was observed.

In accordance with EU CLP (Regulation (EC) No. 1272/2008), classification is not required for acute dermal toxicity or specific target organ effects.

Acute inhalation toxicity of read across substances:

Benzene, mono-C10-13-alkyl derivs., distn. residues, sulfonated, barium salts is a brown viscous liquid material with a low vapour pressure of 0.00227 Pa ar 20°c and is used primarily as a component of lubricants and greases by workers, professionals and consumers. It is expected that inhalation exposure from these uses will be low (negligible potential for generation of inhalable forms and the use of this substance will not result in aerosols, particles or droplets of an inhalable size) and that the most likely route of exposure for workers and consumers is the dermal route. Therefore testing for inhalation toxicity is not scientifically justified (see waiver).

In accordance with REACh regulation, Annex VIII, section 8.5.2, column two, testing for acute inhalation toxicity can be waived.

As a weight-of-evidence approach, the acute inhalation toxicity of the calcium sulfonate read across substance (CAS 61789-86-4, product as manufactured diluted in mineral oil (65/35)) was investigated in CD (Spraque-Dawley derived) rats according to EPA OPP 81-3 (Acute inhalation toxicity). The substance (1.9 mg/L as maximum attainable respirable aerosol) was administered for 4 hours (whole-body exposure) into the breathing zone of the animals (5 male and 5 female rats) as an aerosol. The animals were observed for additional 14 days after exposure. The mean achieved atmosphere concentration was 1.9 mg/L (nominal atmosphere concentration 41 mg/L). The mean mass median aerodynamic diameter was 4.2 µm, and the inhalable fraction (< 10 µm) was 93 %. Clinical signs and mortality rates were determined at approximately fifteen-minute intervals during the first hour of exposure and hourly for the remainder of the exposure period. All animals were observed individually upon removal from the chamber (half-hour after exposure was completed) and hourly for two hours post-exposure. Detailed physical observations were recorded at each interval. During days 2 - 15 (post-exposure), detailed observations were recorded for animals once daily; viability was assessed twice daily. The animals were sacrificed at the end of the study, dissected and examined macroscopically. The symptoms in this group were reduced activity, closed eyes and in a few animals laboured breathing towards exposure completion. Signs exhibited by animals upon removal from the chamber and during the two-hour-post exposure observation period on day 1 included secretory signs, some respiratory signs, hunched appearance and matted coats. During test week 1, test animals exhibited decreasing signs of treatment such as secretory signs and matted coat. These signs mostly abated by day 8 and during test week 2, animals exhibited few continuing signs of treatment. No animal died (mortality 0 %). The body weights of the animals were slightly less than pre-test values after test week 1. This was considered a minimal response to exposure, because in test week 2 the body weights were considered unremarkable. The gross pathology did not reveal effects of the test material. Therefore the LC50 value is > 1.9 mg/L.

In accordance with EU CLP (Regulation (EC) No. 1272/2008) , classification is not required for acute inhalation.

Justification for selection of acute toxicity – oral endpoint
A reliable well documented study conducted with a read-across substance calcium sulfonate (CAS 70024 -69 -0) - best study available

Justification for selection of acute toxicity – dermal endpoint

A reliable well documented study conducted with a read-across substance calcium sulfonate with the same alkyl chain length C20-24 (analogue of CAS 70024-69-0) - best study available

Justification for classification or non-classification

The Barium content is not sufficient on its own to clasify for acute toxicity effects.

The calcium sulfonate read across substance, (CAS 70024 -69 -0), had an acute oral LD50 between 10,000 and 20,000 mg/kg bw. In addition, several supporting acute toxicity studies for calcium sulfonate read across substances revealed LD50 values above the limit for classification. Concerning the acute dermal toxicity, the calcium sulfonate read across substance, (Analogue of CAS 70024-69-0), had an acute dermal LD50 of greater than 2000 mg/kg. Moreover, the calcium sulfonate read across substance, (CAS 115733-09-0, CAS 68783 -96 -0 and CAS 61789 -86 -4)), also had an LD50 value above the limit for classification.

Concerning the acute toxicity after inhalatory exposure, first of all Benzene, mono-C10-13-alkyl derivs., distn. residues, sulfonated, barium salts does not bear a significant risk by this route of exposure. Moreover, a calcium sulfonate read across substance (CAS 61789 -86 -4) was investigated and an LC50 value above 1.9 mg/L (the maximum attainable concentration) was found.

In accordance with Annex VI of CLP (Regualtion EC 1272/2008), Index No. 056 -002 -00 -7, barium salts should be classified in as H302 and H332 (Acute toxicity category 4 via the oral and inhalatory route, respectively). However, Note 1 is assigned to this harmonised entry which indicatest that the concentration stated, or in the absence of such concentrations, the generic concentration set out in the CLP regulation are the percentages by weight of the metallic element calculated with reference to the total weight of the mixture. Based on the molecular weight of the UVCB substance, the concentration is below the crtieria for classification, when calculating the acute toxicity using the acute toxicity estimate (ATE) calcualtion methods. Furthermore, based on the available data for the calcium sulfonate substances presented for these endpoints, the sulfonate moeity demonstrates low systemic toxicity.

Therefore, Benzene, mono-C10-13-alkyl derivs., distn. residues, sulfonated, barium salts does not meet the criteria for classification and labelling for oral, dermal or inhalatory toxicity in accordance with Regulation (EC) No 1272/2008.