Benzenesulfonic acid, 4-C20-24 (even numbered) sec-alkyl derivs., sodium salts

Endpoint summary

Description of key information

No acute toxicity data of the target substance is available. Data from the supporting substance LABS Na is used to cover this endpoint. One key and 3 supporting studies are identified. In the key, K2 study, performed according to OECD guideline 401, an LD50 of 1080 mg/kg was established in male and female rats. In one key dermal acute toxicity study, the LD50 was set at >2000 mg/kg. 

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:

experimental study

Adequacy of study:

key study

Study period:

Jan. 1, 1984-Feb. 14, 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented publication/study report which meets basic scientific principles.

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:

- Name of test material (as cited in study report): Marlon A 386 (CAS #68411-30-3) C10-13 LAS
- Composition of test material, percentage of components: average alkyl chain length = C11.6;
- Analytical purity: Activity: 86%
- Physical state: cloudy, beige, thick paste

Species:

rat

Strain:

not specified

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann
- Weight at study initiation: 123 g female, 146 g male
- Fasting period before study:
- Housing: 1-5 animals in Makrolon cages,
- Diet (e.g. ad libitum): R10 Alleidiaet fuer Ratten, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 4-8 days


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

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 12.5-19.9% in water

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

LAS doses of 1075, 1220, 1360, 1710 or a control
Note that all doses are corrected for 86% activity. The original doses were 1250, 1415, 1580 and 1990 mg/kg.

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

Body weight and other signs were measured on days 7 and 14.
Animals were observed for 14 days after dosing.
Necropsies were performed at the end of the study.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 080 mg/kg bw

Based on:

act. ingr.

Mortality:

Virtually all animals died in doses of 1220 mg/kg and above.

Clinical signs:

Symptoms beginning about 30 minutes past application included diarrhea, squatting attitude, breathing difficulties, nose bleeding, ataxia, and lethargy. These symptoms had disappeared in surviving animals by 120 hours.

Body weight:

No effects to body weight were seen.

Gross pathology:

In the animals that died before the end of the study, red mucous was seen in the stomach and intestine. In the surviving animals, hyperemia of the stomach was noted, along with abnormalities of the stomach, liver, spleen, kidneys, and the peritoneum.

Mortality

Dose (mg/kg)	Sex	Mortality
1075	Male	0
	Female	4
1220	Male	5
	Female	3
1360	Male	4
	Female	5
1710	Male	5
	Female	5

Interpretation of results:

Toxicity Category IV

Conclusions:

The acute oral LD50 is 1080 mg/kg. According to EU GHS guidelines, the test substance is a Category IV toxicant.

Executive summary:

This study examined the oral toxicity of the test substance in rats. Groups of 5 male and 5 female rats were exposed orally to 0, 1075, 1220, 1360, or 1710 mg/kg of test substance. The animals were then monitored for 14 days for mortality and clinical signs. All animals showed signs of toxicity. Mortality was seen at all dose levels, with 4 of 10 animals at the lowest dose level dying. All animals at the highest dose level died. The acute oral LD50, when adjusted for activity was 1080 mg/kg. According to EU GHS guidelines, the test substance is a Category IV toxicant.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Feb. 1, 1984-Feb. 21, 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented publication/study report which meets basic scientific principles.

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:

- Name of test material (as cited in study report): Marlon A 360 (CAS #68411-30-3) C10-13 LAS
- Composition of test material, percentage of components: average alkyl chain length = C11.6;
- Analytical purity: Activity: 60%
- Physical state: cloudy, yellow-brown, paste-like
- Density: 1.0 mg/ml at 20°C

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Weight at study initiation: 111 g female, 121 g male
- Fasting period before study: 16 hours
- Housing: 1-5 animals in Makrolon cages, type III
- Diet (e.g. ad libitum): R10 Alleindiaet fuer Ratten, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 4-8 days


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

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 3.16 mL/kg

Doses:

2510, 2835, 3160 mg/kg test substance (Volume: 2.51 - 3.16 mL/kg)

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: Clinical signs (occurrence, nature and duration) and time of death were observed up to 6 hours after treatment and daily thereafter, weighing was performed before treatment and on days 1, 7 and 14 after treatment.
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 760 mg/kg bw

Based on:

test mat.

95% CL:

2 579 - 2 953

Mortality:

2510 mg/kg: 1 male and 2 females died within 24 hours
2835 mg/kg: 1 male and 4 females died within 24 hours
3160 mg/kg: 5 males and 4 females died within 24 hours

Clinical signs:

All animals showed signs of toxicity. Symptoms beginning about 60 minutes past application included piloerection, diarrhea, squatting attitude, diuresis, ataxia, nose bleeding and slight sedation. These symptoms had disappeared in surviving animals by 6 days.

Body weight:

No effects to body weight were seen.

Gross pathology:

In the animals that died before the end of the study, red mucous was seen in the stomach and intestine. In some of the surviving animals, partial swelling of gastric mucosa and hyperemia of the small intestine was noted and in two animals adhesion of stomach, liver, spleen, and peritoneum was observed.

Mortality

Dose (mg/kg)	Sex	Mortality
2510	Male	1
	Female	2
2835	Male	1
	Female	4
3160	Male	5
	Female	4

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 is 2760 mg/kg. According to EU GHS guidelines, the test substance is not classified.

Executive summary:

This study examined the oral toxicity of the test substance in rats. Groups of 5 male and 5 female rats were exposed orally to 2510, 2835, or 3160 mg/kg of test substance. The animals were then monitored for 14 days for mortality and clinical signs. All animals showed signs of toxicity. Mortality was seen at all dose levels, with 3 of 10 animals at the lowest dose level dying. 9 of 10 animals at the highest dose level died. The acute oral LD50 was 2760 mg/kg. According to EU GHS guidelines, the test substance is not classified.

Reference 3

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Feb. 1, 1984-Feb. 21, 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented publication/study report which meets basic scientific principles.

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:

- Name of test material (as cited in study report): Marlon A 386 (CAS #68411-30-3) C10-13 LAS
- Composition of test material, percentage of components: average alkyl chain length = C11.6;
- Analytical purity: Activity: 65%
- Physical state: cloudy, white-yellow, pasty

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann
- Weight at study initiation: 111 g female, 121 g male
- Fasting period before study: 16 hours
- Housing: 1-5 animals in Makrolon cages, type III
- Diet (e.g. ad libitum): R10 Alleindiaet fuer Ratten, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 4-8 days


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

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 39.8-50.2% in water

MAXIMUM DOSE VOLUME APPLIED: 5.0 ml/kg

Doses:

1990, 2250, 2510 mg/kg test substance

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: Clinical signs (occurrence, nature and duration) and time of death were observed up to 6 hours after treatment and daily thereafter, weighing was performed before treatment and on days 1, 7 and 14 after treatment.
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 190 mg/kg bw

Based on:

test mat.

95% CL:

>= 2 047 - <= 2 343

Mortality:

1990 mg/kg: 2 male animals died within 28 hours, none of the females died
2250 mg/kg: 2 males and 4 females died within 48 hours
2510 mg/kg: 4 males and all females died within 28 hours

Clinical signs:

All animals showed signs of toxicity. Symptoms beginning about 30 minutes past application included piloerection, diarrhea, squatting attitude, ataxia, tremor, staggering and slight sedation. These symptoms had disappeared in surviving animals by 72 hours.

Body weight:

No effects to body weight were seen.

Gross pathology:

In the animals that died before the end of the study, red mucous was seen in the stomach and intestine. In some of the surviving animals, partial swelling of gastric mucosa and hyperemia of the small intestine was noted and adhesion of stomach, liver, spleen, and peritoneum.

Mortality

Dose (mg/kg)	Sex	Mortality
1990	Male	2
	Female	0
2250	Male	2
	Female	4
2510	Male	4
	Female	5

Interpretation of results:

relatively harmless

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 is 2190 mg/kg. According to EU GHS guidelines, the test substance is not classified.

Executive summary:

This study examined the oral toxicity of the test substance in rats. Groups of 5 male and 5 female rats were exposed orally to 1990, 2250 or 2510 mg/kg of test substance. The animals were then monitored for 14 days for mortality and clinical signs. All animals showed signs of toxicity. Mortality was seen at all dose levels, with 2 of 10 animals at the lowest dose level dying. 9 of 10 animals at the highest dose level died. The acute oral LD50 was 2190 mg/kg. According to EU GHS guidelines, the test substance is not classified.

Reference 4

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

Feb. 1, 1984-Feb. 15, 1984

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well-documented publication/study report which meets basic scientific principles.

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:

- Name of test material (as cited in study report): Marlon A 386 (CAS #68411-30-3) C10-13 LAS
- Composition of test material, percentage of components: average alkyl chain length = C11.6;
- Analytical purity: Activity: 75%
- Physical state: cloudy, beige, thick paste

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann
- Weight at study initiation: 102 g female, 108 g male
- Fasting period before study: 16 hours
- Housing: 1-5 animals in Makrolon cages, type III
- Diet (e.g. ad libitum): R10 Alleindiaet fuer Ratten, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: 4-8 days


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

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 12.5-19.9% in water

MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg

Doses:

1250, 1580, 1990 mg/kg test substance

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: Clinical signs (occurrence, nature and duration) and time of death were observed up to 6 hours after treatment and daily thereafter, weighing was performed before treatment and on days 1, 7 and 14 after treatment.
- Necropsy of survivors performed: yes

Sex:

male/female

Dose descriptor:

LD50

Effect level:

1 600 mg/kg bw

Based on:

test mat.

95% CL:

1 455 - 1 760

Mortality:

1250 mg/kg: 1 male and 1 female animal died within 24 hours
1580 mg/kg: 2 males and 2 females died within 24 hours
1990 mg/kg: 4 males and 4 females died within 48 hours

Clinical signs:

All animals showed signs of toxicity. Symptoms beginning about 30 minutes past application included piloerection, diarrhea, squatting attitude, disorders of balance, ataxia and slight sedation. These symptoms had disappeared in surviving animals by 72 hours.

Body weight:

No effects to body weight were seen.

Gross pathology:

In the animals that died before the end of the study, red mucous was seen in the stomach and intestine. In some of the surviving animals, partial swelling of gastric mucosa and hyperemia of the small intestine was noted along with adhesion of stomach, liver, and spleen.

Mortality

Dose (mg/kg)	Sex	Mortality
1250	Male	1
	Female	1
1580	Male	2
	Female	2
1990	Male	4
	Female	4

Interpretation of results:

Toxicity Category IV

Conclusions:

The acute oral LD50 is 1600 mg/kg. According to EU GHS guidelines, the test substance is a Category IV toxicant.

Executive summary:

This study examined the oral toxicity of the test substance in rats. Groups of 5 male and 5 female rats were exposed orally to 1250, 1580 or 1990 mg/kg of test substance. The animals were then monitored for 14 days for mortality and clinical signs. All animals showed signs of toxicity. Mortality was seen at all dose levels, with 2 of 10 animals at the lowest dose level dying and 8 of 10 animals at the highest dose level. The acute oral LD50 was 1600 mg/kg. According to EU GHS guidelines, the test substance is a Category IV toxicant.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 080 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

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

No acute toxicity data of the target substance is available. A read-across evaluation was developed to fill data gaps with LABS Na as the source substance.

acute toxicity: oral

One key and three supporting substances with LABS Na were identified.

The key study examined the oral toxicity of the test substance in rats. Groups of 5 male and 5 female rats were exposed orally to 0, 1075, 1220, 1360, or 1710 mg/kg of test substance. The animals were then monitored for 14 days for mortality and clinical signs. All animals showed signs of toxicity. Mortality was seen at all dose levels, with 4 of 10 animals at the lowest dose level dying. All animals at the highest dose level died. The acute oral LD50, when adjusted for activity was 1080 mg/kg.

The supporting studies examined the oral toxicity for various concentrations of the test substance (75%, 65% and 60%) in rats. The studies followed the same test protocol and methods as the key study. The effects and symptoms observed with the key study for the test substance were also observed in the supporting study. The acute oral LD50’s determined for the concentrations were 1600 mg/kg, 2190 mg/kg and 2760 mg/kg for 75%, 65% and 60% actives, respectively.

According to CLP-Regulation, the test substance is a Category 4 toxicant (H302: Harmful if swallowed) at concentrations equal to or greater than 65%, while it is not classified at lower concentrations.

acute toxicity: inhalation

No key data is available for the target or source substance

acute toxicity: dermal

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

Justification for classification or non-classification

Based on the results above, the test substance is to be classified as acute oral toxicant category 4 according to CLP Regulation, but not as acute dermal toxicant.