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Administrative data

Description of key information

Acute oral toxicity: LD50 of greater than 5000 mg/kg bw was established for acute oral toxicity for the read-across substances sodium and calcium benzene sulfonates in all available studies.
Acute dermal toxicity: LD50 of greater than 2000 mg/kg bw was established for acute oral toxicity for the read-across substances calcium benzene sulfonates in all available studies.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1982-03-06 to 1982-06-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: acceptable well-documented study reports which meets basic scientific pronciples.
Qualifier:
equivalent or similar to
Guideline:
other: 40 CFR Section 772.112-21.
Deviations:
no
Principles of method if other than guideline:
One group of ten (5 male and 5 female) albino rats of the outbred Sprague-Dawley Strain were administered orally to undiluted 5000 mg/kg bw and then observed during 14 days for signs of mortality and toxicity. Individual weights were recorded on the day of dosage, weekly thereafter, and prior to sacrifice.
GLP compliance:
no
Remarks:
the study was conducted prior to the adoption of GLP compliance
Test type:
acute toxic class method
Limit test:
yes
Species:
rat
Strain:
other: outbred albino Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source:
- Age at study initiation: not reported
- Weight at study initiation: between 200 and 300 g
- Fasting period before study: The rats were deprived of food but not water overnight prior to dosing.
- Housing: Stainless steel with elevated wire mesh flooring 3-5 rats/cage by sex; Tachboard Shepherd Products Company Kalamazoo, Michigan 49005
- Diet (e.g. ad libitum): Wayne Lab-Blox diet ad libitum (except overnight prior to dosing)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: not reported

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 72 ± 2 °F corresponds to 21°C
- Humidity (%): 45 ± 5
- Air changes (per hr): not reported
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:
Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
No details reported
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
Each animal was weighed and dosed by direct administration of the experimental material into the stomach by means of a syringe and dosing needle.
- Duration of observation period following administration: 14 days. Animals were observed frequently on the day of dosage, and twice per day thereafter (morning and afternoon).
- Frequency of observations and weighing: Individual weights were recorded on the day of dosage, weekly thereafter, and prior to sacrifice.
- Necropsy of survivors performed: yes. Gross autopsies were performed on all animals which died during the 14 day observation period and also on all survivors of the 14 day observation period
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no effects
Mortality:
Two deaths (males) occurred within 24 hours. The death of 1 female on day 5 was not preceded by any apparent abnormal clinical signs.
Clinical signs:
All the animals appeared ruffled after 3 hours. The genital area of the surviving animals appeared soiled within 24 hours. Females returned to normal within 48 hours and surviving males within 4 days. The remaining animals continued to appear normal throughout the remainder of the observation period.
Body weight:
The animals gained in body weight (males: 274, 401 and 421 g on day 1, 7 and 14, respectively; females: 237, 282 and 326 g on day 1, 7 and 14, respectively).
Gross pathology:
Lungs, livers and spleen appeared pale and mottled in the anymals dying during the observation period. No remarkable findings attributable to the test material were observed in the other animals sacrificed at the conclusion of the observation period.
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
An acute LD50 greater than 5000 mg/kg bw was established for male and female rats.
Executive summary:

One group of ten (5 male and 5 female) albino rats of the outbred Sprague-Dawley Strain weighing between 200 and 300 gm was employed in this study. The rats were deprived of food but not water overnight prior to dosing. Each animal was weighed and dosed by direct administration of the experimental material into the stomach by means of a syringe and dosing needle. The sample was dosed as supplied. The following dosage level was administered: 5.0 gm/kg. Following administration the animals were allowed food and water ad libitum for the 14 day observation period during which time the rats were observed for signs of toxicity and mortalities. Animals were observed frequently on the day of dosage, and twice per day thereafter (morning and afternoon). Individual weights were recorded on the day of dosage, weekly thereafter, and prior to sacrifice. The animals were euthanized at the conclusion of the observation period with carbon dioxide. Gross autopsies were performed on all animals which died during the 14 day observation period and also on all survivors of the 14 day observation period. Two deaths (males) occurred within 24 hours. The death of 1 female on day 5 was not preceded by any apparent abnormal clinical signs. All the animals appeared ruffled after 3 hours. The genital area of the surviving animals appeared soiled within 24 hours. Females returned to normal within 48 hours and surviving males within 4 days. The remaining animals continued to appear normal throughout the remainder of the observation period. The surviving animals animals gained in body weight (males: 274, 401 and 421 g on day 1, 7 and 14, respectively; females: 237, 282 and 326 g on day 1, 7 and 14, respectively). Lungs, livers and spleen appeared pale and mottled in the anymals dying during the observation period. No remarkable findings attributable to the test material were observed in the other animals sacrificed at the conclusion of the observation period. The subject material when studied in male and female albino rats has an acute oral LD50 greater than 5.0 gm/kg.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
5 000 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
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
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:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1989
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:
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 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:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: EU-GHS
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 read across 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, 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 the Benzenesulfonic acid, mono-C20-24 (even)-sec-alkyl derivs., para-, sodium salts (generic name: C20-24 sodium sulfonate). Therefore, results of acute studies of structurally similar read-across substances sodium and calcium sulfonates are used to assess acute toxicity potential of the C20-24 sodium sulfonate.

Acute oral toxicity data of read across substances:

In a key study, the acute oral toxicity of the read-across substance sulfonic acids, petroleum, sodium salts (CAS 68608-26-4) was studied in a group of ten (5 male and 5 female) albino rats of the outbred Sprague-Dawley Strain (Gilman, 1982; Study No. 82-3157A). The animals weighed between 200 and 300 g. The rats were deprived of food but not water overnight prior to dosing. Each animal was weighed and dosed by direct administration of the test material at dosage level of 5000 mg/kg bw into the stomach by means of a syringe and dosing needle. The sample was dosed as supplied. Following administration the animals were allowed food and water ad libitum for the 14 day observation period during which time the rats were observed for signs of toxicity and mortalities. Animals were observed frequently on the day of dosage, and twice per day thereafter (morning and afternoon). Individual weights were recorded on the day of dosage, weekly thereafter, and prior to sacrifice. The animals were euthanized at the conclusion of the observation period with carbon dioxide. Gross autopsies were performed on all animals which died during the 14 day observation period and also on all survivors of the 14 day observation period. Two deaths (males) occurred within 24 hours. The death of 1 female on day 5 was not preceded by any apparent abnormal clinical signs. All the animals appeared ruffled after 3 hours. The genital area of the surviving animals appeared soiled within 24 hours. Females returned to normal within 48 hours and surviving males within 4 days. The remaining animals continued to appear normal throughout the remainder of the observation period. The surviving animals gained in body weight (males: 274, 401 and 421 g on day 1, 7 and 14, respectively; females: 237, 282 and 326 g on day 1, 7 and 14, respectively). Lungs, livers and spleen appeared pale and mottled in the animals dying during the observation period. No remarkable findings attributable to the test material were observed in the other animals sacrificed at the conclusion of the observation period.

The subject material when studied in male and female albino rats has an acute oral LD50 greater than 5000 mg /kg bw.

In another key study, the acute oral toxicity of the read-across substance sulfonic acids, petroleum, sodium salts (CAS 68608-26-4) was studied in one group of ten (5 male and 5 female) albino rats of the outbred Sprague-Dawley Strain (Costello, 1983). The animals weighed between 200 and 300 g. The rats were deprived of food but not water overnight prior to dosing. Each animal was weighed and dosed by direct administration of the experimental material into the stomach by gavage. The dosage level of 5000 mg/kg bw as 50% w/w suspension in corn oil was administered to animals. Following administration the animals were allowed food and water ad libitum for the 14 day observation period during which time the rate were observed for signs of toxicity and mortality. Animals were observed frequently on the day of dosage, and twice per day thereafter (morning and afternoon). Individual weights were recorded on the day of dosage, and average group weights were recorded at 7 and 14 days after dosing. A gross necropsy was performed on the animal that was found dead on day 5 of the study and on the remaining animals at the conclusion of the study. All animals appeared ruffled after 4 hours post exposure. The animals remained ruffled after 24 hours and exhibited diarrhea. Male animals appeared normal 48 hours through 14 days after exposure. The surviving female animals appeared normal on day 6 through 14 days after exposure. All animals gained weight. In males and in four survived females necropsied at the conclusion of 14 days observation period, no gross abnormalities were noted. In the female found dead, pale kidneys were noted. LD50 greater than 5000 mg/kg bw was established for both sexes.

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 a supporting 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 20000 dose group. Therefore, the LD50 value is between 10,000 and 20,000 mg/kg bw.

In another supporting acute oral toxicity study (Sanitised, F., 1989) Sprague-Dawley rats (5/sex) were given a single oral dose (5000 mg/kg bw) of the calcium sulfonate read across substance (analogue of CAS 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.

In another supporting study investigating the acute oral toxicity of the calcium sulfonate read across substance, CAS 115733-09-0 (Sanitised, A., 1981) Sprague-Dawley rats (5/ sex) 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, groups of Sprague-Dawley rats (5/sex/dose) were given a single oral dose of calcium sulfonate read across substance (CAS 68783-96-0) at 5,000 mg/kg bw and observed for 14 days (Sanitised, C., 1984). No mortality occurred in this limit test, therefore an LD50 has not been determined. The 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.

In several supporting acute oral toxicity studies with petroleum derived calcium salts (CAS 61789-86-4), LD50 greater than 5000, 10,000, 16, 000 20,000 were established (Sanitised, E, 1985; Regel, 1970; Gabriel, 1981a; Ohees, 1968a,b).

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 a 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 2.0 g/kg. No evidence of systemic toxicity was observed.

In a supporting study, acute dermal toxicity potential of another calcium sulfonate read across substance (CAS 115733-09-0) was investigated in male and female rabbits (5/sex). The animals were treated with a single dose of 5000 mg/kg bw dermally for 24 h and observed for 14 days. As no mortality occurred, this study also showed the LD50 value > 5000 mg/kg bw and thereby to be above the limit for classification (Sanitised, B., 1981).

In another supporting study, 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 2000 mg/kg bw and observed for 14 days (Sanitised, J., 1993). No mortality occurred in this limit test, therefore an LD50 has not been determined. The 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 another supporting study, the acute dermal toxicity of the calcium sulfonate read-across substance (CAS 61789-86-4) was investigated in rabbits (Costello, 1986a). The test article was dosed as supplied, at a dose level of 4.0 g/kg for 24 hours. A group of 10 rabbits (5 male & 5 female) with healthy intact skin was used. 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. Other than the above skin observations, all animals appeared normal throughout the 14 day observation period. In females the symptoms were similar. 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 test material.In conclusion,the test article when dosed as supplied appears to have an acute dermal LD50 greater than 4.0 g/kg (4000 mg/kg bw, respectively).

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:

Benzenesulfonic acid, mono-C20-24 (even)-sec-alkyl derivs., para-, sodium salts (generic name: C20-24 sodium sulfonate) is a liquid with a vapour pressure of 0.0259 Pa at 25 °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 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)

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 sodium sulfonate (CAS 68608-26-4)

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).

Justification for classification or non-classification

The read across substances sodium sulfonates (CAS 68608-26-4), had an acute oral LD50 of greater than 5000 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 bw. Moreover, the calcium sulfonate read across substances, (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 the Benzenesulfonic acid, mono-C20-24 (even)-sec-alkyl derivs., para-, sodium salts (generic name: C20 -24 sodium sulfonate) does not bear a significant risk by this route of exposure. Moreover, 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.

Therefore, the C20 -24 sodium sulfonate does not meet the criteria for classification and labelling for oral, dermal or inhalatory toxicity in accordance with European regulation (EC) No. 1272/2008.