Benzenesulfonic acid, 4-mono-C20-24 (even numbered)-alkyl derivs., magnesium salts

Endpoint summary

Description of key information

Read across: Oral: LD50 > 16,000 mg/kg, rats
Read Across: Dermal: LD50 > 2000 mg/kg, rats, limit test

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

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:

1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Qualifier:

according to guideline

Guideline:

other: FHSA 16CFR 1500.3

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Species:

rat

Strain:

Sherman

Sex:

male

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

single dose of undiluted test material administered by oral gavage (intragastrically)
MAXIMUM DOSE VOLUME APPLIED: 16 ml/kg bw
Dose volumes: 1, 2, 4, 8 and 16 mL/kg

Doses:

1000, 2000, 4000, 8000 and 16000 mg/kg bw

No. of animals per sex per dose:

5 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Weights were recorded on day of dosing and at termination
- Necropsy of survivors performed: yes

Statistics:

Use of statistics not indicated

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 16 000 mg/kg bw

Remarks on result:

other: 95% CL not determined

Mortality:

Mortality did not occur in treated animals. No deaths were observed during the 14-day observation period.

Clinical signs:

other: Animals dosed with 8000 and 16000 mg/kg bw exhibited ruffled fur for 18-24 hours post dosing. They appeared normal within 48 hours.

Gross pathology:

No treatment related effects were observed on necropsy.

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
1000	0/5	-	-	-	0/5	-	-
2000	0/5	-	-	-	0/5	-	-
4000	0/5	-	-	-	0/5	-	-
8000	0/5	-	-	-	5/5	-	-
16000	0/5	-	-	-	5/5	-	-

No deaths were observed during the 14-day observation period. The animals at 8 and 16 g/kg exhibited ruffled fur for 18-24 hours post dosing. Within 48 hours all animals appeared normal. No body weight effects were observed. Gross necropsy findings were unremarkable.

The test article, when administered as received to male Sherman-Wistar rats, had an acute oral LD50 of greater than 16.0 g/kg

Interpretation of results:

Toxicity Category IV

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Mortality did not occur at doses of 16000 mg/kg bw, therefore an LD50 was not determined.

Executive summary:

In an acute oral toxicity study, groups of 5 male Sherman rats were given a single oral dose of alkaryl magnesium salt derivatives at doses of 1000, 2000, 4000, 8000 and 16000 mg/kg bw and observed for 14 days. No mortality occurred, therefore an LD50 has not been determined. Animals dosed with 8000 and 16000 mg/kg bw exhibited ruffled fur for 18-24 hours post dosing but they appeared normal within 48 hours. No significant change in bodyweights occurred in treated animals. No treatment related effects were observed on necropsy. This acute oral toxicity study is acceptable. It satisfies the guideline requirement for an acute oral study in the rat. The test article, when administered as received to male Sherman-Wistar rats, had an acute oral LD50 of greater than 16.0 g/kg.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral 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:

None provided in study report.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw (intragastrically)

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

Animals were observed for 14 days following administration of the test substance.
Bodyweights were recorded on the day of dosing and at 2, 7 and 14 days after dosing.

Necropsy of survivors performed: yes

Clinical signs were observed and bodyweights measured.

Statistics:

No mortality occurred. Use of statistics not indicated.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000

Remarks on result:

other: 95% CL not indicated. LD50 is greater than 5000 mg/kg bw.

Mortality:

Mortality did not occur in treated animals.

Clinical signs:

other: Diarrhoea and reduced food intake were observed in one treated female on day one of dosing. No other signs of toxicity were observed.

Gross pathology:

No treatment related effects were observed on necropsy.

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
Control	0/5	0/5	0/10		0/5	0/5	0/10
5000	0/5	0/5	0/10		0/5	1/5	0/10

No mortality was observed. Diarrhoea and reduced food intake were observed in one female on Day 1. No other signs of toxicity were observed. Body weights were unremarkable.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: EU-GHS

Conclusions:

No mortality has occurred at doses of 5000 mg/kg bw. The study has therefore been completed as a limit test and the LD50 is considered to be more than 5000mg/kg

Executive summary:

In an acute oral toxicity study, groups of Sprague-Dawley rats (5/sex) were given a single oral dose of the calcium sulfonate read across substance (analogue of 70024 -69 -0) at doses of 0 or 5,000  mg/kg bw and observed for 14 days. No mortality occurred in this limit test, therefore an exact LD50 has not been determined. This acute oral study is classified as acceptable. It satisfies the guideline requirement for an acute oral study OECD 401 in the rat.  Therefore 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.

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Study period:

1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw, dose volume: adjusted for specific gravity of 0.94 g/mL.

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

Animals were observed for 14 days following administration of the test substance.
Bodyweights were recorded on the day of dosing and at 2, 7 and 14 days after dosing.

Necropsy of survivors performed: yes

Clinical signs were observed and bodyweights measured.

Statistics:

No mortality occurred. Use of statistics not indicated.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: 95% CL not indicated. LD50 is greater than 5000 mg/kg bw.

Mortality:

Mortality did not occur in treated animals.

Clinical signs:

other: Animals exhibited slight diarrhoea 2 hours post dosing. Most animals had slight diarrhoea and anal staining on day 1. Two rats had slight bloody nasal discharge on days 2 and 3.

Gross pathology:

No treatment related effects were observed on necropsy.

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	0/5	0/5	0/10		0/5	0/5	0/10

No mortality was observed. Two rats exhibited slight diarrhoea two hours post dosing. On Day 1., most rats had slight diarrhoea and anal stains. Two rats exhibited slight bloody nasal discharge on Days 2 and 3. All rats were normal on days 4 through 14. No other signs of toxicity were observed. Body weights and necropsy findings were unremarkable.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: EU-GHS

Conclusions:

No mortality has occurred at doses of 5000 mg/kg bw. The study has therefore been completed as a limit test and the LD50 is considered to be more than 5000 mg/kg.

Executive summary:

In an acute oral toxicity study, groups of Sprague-Dawley rats (5/sex) were given a single oral dose of C14-24 alkaryl calcium salt derivatives at 5000 mg/kg bw and observed for 14 days. No mortality occurred in this limit test, therefore an exact LD50 has not been determined. This acute study is classified as acceptable. It satisfies the guideline requirement for an acute oral study in the rat. The test article, when administered as received to 5 male and 5 female Sprague-Dawley rats, had an acute oral LD50 of greater than 5.0 g/kg.

Reference 4

Endpoint:

acute toxicity: oral

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting 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:

other: 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	0/0	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:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: EU-GHS

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 at 5000, 10000 or 20000 mg/kg bw and observed for 14 days. Mortality occurred at 20000 mg/kg bw, therefore the LD50 is considered to be between 10000 and 20000 mg/kg bw. This acute study is classified as acceptable. It satisfies the guideline requirement for an acute oral study in the rat.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

16 000 mg/kg bw

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

Reference 1

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

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.

Key result

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:

other: No clinical signs of toxicity were observed in treated animals.

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 Benzenesulfonic acid, mono-C20-C24-alkyl derivs., calcium salts, (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 LD50 has not been determined. This acute study is classified as acceptable. It satisfies the guideline requirement for an acute dermal study in the rat. 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 2,0000 mg/kg. No evidence of systemic toxicity was observed.

Reference 2

Endpoint:

acute toxicity: dermal

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

animal skin was abraded prior to dosing

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

Dose level: 5 g/kg
Dose volume 5 mL/kg

Duration of exposure:

24 hours

Doses:

5000 mg/kg bw

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: 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:

No mortality occurred. Use of statistics not indicated.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: 95% CL not indicated.

Mortality:

Mortality did not occur in treated animals.

Clinical signs:

other: Animals showed distress at bandage removal 24 hours following dosing. Skin at the administration site was red, swollen and stained with test material. Irritation subsided by day 9, however, the skin remained dry, flaky and stained throughout the observati

Gross pathology:

One animal had a friable, white, mottled left liver lobe. One animal had a small right testis.

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
5000		0/5	0/5	0/10		5/5	5/5	10/10

Rabbits were normal at 0, 2 and 4 hours post dosing. Upon bandage removal at 24 hours rabbits were distressed. Skin at the dose site was red, swollen and stained with test material. Irritation subsided by day 9, however the skin remained dry, flaky and stained throughout the observation period. All animals gained weight during the study. No systemic toxicity was observed. At necropsy 9 rabbits exhibited alopecia, matted fur and flaky skin at or around the test site. One animal had a friable, white, mottled left front liver lobe. One rabbit had a small right testis.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: EU-GHS

Conclusions:

No mortality has occurred at doses of 5000 mg/kg bw. The study has therefore been completed as a limit test and the LD50 is considered to be more than 5000 mg/kg.

Executive summary:

In an acute dermal toxicity study, groups of New Zealand white rabbits (5/sex) were dermally exposed for 24 hours to C14-24 alkaryl calcium salt derivative at doses of  5000 mg/kg bw.  Animals then were observed for 14 days. No mortality occurred in this limit test, therefore an LD50 has not been determined. This acute study is classified as acceptable. It satisfies the guideline requirement for an acute dermal study in the rabbit. 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 5,000 mg/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

Additional information

Acute oral toxicity data of read across substances:

In an acute oral toxicity study (Sanitised, A., 1980, Key study), groups of 5 male Sherman rats were treated with a single oral dose of magnesium sulfonate read across substance, (CAS 71786-47-5), at doses of 1000, 2000, 4000, 8000 and 16000 mg/kg bw and observed for 14 days. No mortality occurred. Animals dosed with 8000 and 16000 mg/kg bw exhibited ruffled fur for 18-24 hours post dosing but they appeared normal within 48 hours. No significant change in bodyweights occurred in treated animals. No treatment related effects were observed on necropsy, and no mortality occurred. The acute oral LD50 was greater than 16.0 g/kg.

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 study (Swan, 1972) Sprague-Dayley 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, D., 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 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, B., 1981). In this study 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.

Acute dermal toxicity data of read across substances:

In the key acute dermal toxicity study (Sanitised, E., 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.

An acute dermal toxicity supporting study with another calcium sulfonate read across substance (CAS 115733-09-0) in male and female rabbits (5/sex) 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, C., 1981).

Acute inhalation toxicity:

The substance is a liquid with a vapour pressure of 1.0 x 10-2 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. However, the data on the magnesium sulfonate target substance and the magnesium and calcium sulfonate read across substances are sufficient for assessing oral and dermal acute toxicity.

Justification for selection of acute toxicity – oral endpoint
best study available

Justification for selection of acute toxicity – dermal endpoint
best study available

Justification for classification or non-classification

The read across substances magnesium sulfonate read across substance, (CAS 71786-47-5), had an acute oral LD50 of greater than 16.0 g/kg. 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 2.9 g/kg. Moreover, the calcium sulfonate read across substance, (CAS 115733-09-0), also had an LD50 value above the limit for classification. Therefore, the magnesium sulfonate target substance does not meet the criteria for classification and labelling for oral or dermal toxicity in accordance with European regulation (EC) No. 1272/2008.