Benzenesulfonic acid, 4-C15-16-sec-alkyl derivs.-, compd. with 1-aminopropane-2-ol

Endpoint summary

Description of key information

Reliable acute oral toxicity studies for available for the two read across substances Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts and MIPA, while an acute dermal toxicity study is available for Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts.

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

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:

key study

Study period:

06. Oct 1965- 25. Oct 1965

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

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

Principles of method if other than guideline:

BASF-Test: The study was conducted according to an internal BASF method which in principle is comparable to the OECD Guideline 401.
A test group consisting of 5 animals/sex was treated by single gavage application with an aqueous solution of the test substance. The animals were observed for mortality and for clinical symptoms of toxicity. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy.

GLP compliance:

no

Test type:

other: BASF-test

Limit test:

no

Species:

rat

Strain:

other: US-rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: male: 190.7 g (mean); female: 154.9 g (mean)

Route of administration:

oral: gavage

Vehicle:

water

Doses:

0.2, 1.6, 2.0, 2.5, 3.2, 6.4 ml/kg bw (194, 1552, 1940, 2425, 3104, 6208 mg/kg bw ; conversion in mg/kg bw was calculated from the original ml/kg values by using the density of 0.97g/cm3 (according to the BASF MSDS).

No. of animals per sex per dose:

5

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, histopathology

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 813 mg/kg bw

Remarks on result:

other: The LD50 was calculated from the original ml/kg values by using the density of 0.97g/cm3

Mortality:

See details in table in remarks on results.

Clinical signs:

After the application the high dose animals showed restlessness, stagger, creep, slight abdominal position, anemia and mouth discharge. At all dose groups compulsive chewing, dyspnoea and apathy were observed. In the middle groups also tonic-clonic convulsions were noted.
Exitus occurred overnight. The surviving animals recovered only slowly and showed apathy, dyspnoea, partly slight stagger and decelerated motion

Body weight:

no data

Gross pathology:

6208 mg/kg: red discoloration of abdominal viscus.
3104 mg/kg: 2 animals showed reddish livid discoloration of the abdominal viscus.
2425 mg/kg: 2 animals showed irritation of the bowel and 1 animal dilatation of the stomach.
1940 mg/kg: 1 animal showed bronchitis and bronchiectasia.
1557 mg/kg: no abnormalities.
194 mg/kg: 2 animals showed bronchitis and bronchiectasia.

Mortality:

Dose (mg/kg bw)

Conc.(%)

1h

24 h

48 h

7 days

14 days

6208

30

0/10

10/10

10/10

10/10

10/10

3104

30

1/10

7/10

7/10

7/10

-

2425

20

0/10

2/10

2/10

2/10

2/10

1940

20

0/10

1/10

1/10

1/10

1/10

1557

20

0/10

0/10

0/10

0/10

0/10

194

2

0/10

0/10

0/10

0/10

0/10

The 3 surviving animals of the 3104 mg/kg bw group were sacrificed on day 7.

The test substance caused systemic toxicity, including mortality, after a single ingestion.

Conclusions:

The LD50 of MIPA to male and female rats was 2813 mg/kg.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

1 080 mg/kg bw

Acute toxicity: via inhalation route

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:

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

Adequacy of study:

key study

Justification for type of information:

see read-across document

Reason / purpose for cross-reference:

read-across source

Key result

Sex:

not specified

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Remarks on result:

other: undiluted

Mortality:

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

Clinical signs:

There were no signs of systemic reaction. Well defined or slight erythema and slight oedema were observed at all test sites after removal of the occlusive dressings. These reactions were unresolved before progressive hardening of the skin was first detected on day 4. All test sites were entirely covered by scab formation from day 7. Sloughing from the scabbed skin began at various times between day 7 and day 12 and was completed before test termination.

Body weight:

Low bodyweight gains or loss of bodyweight were recorded for one male and three female rats on day 8. Two of the same females and a third female rat also showed low bodyweight gains between days 8 and 15.

Gross pathology:

All terminal autopsy findings were normal.

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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

Executive summary:

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

The acute toxicity of the read-across substance Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts was examined via both the oral and dermal routes of exposure. In the oral exposure study, mortality was observed at all dose levels and the resulting acute oral LD50 was 1080 mg/kg. In the dermal test, no mortality was seen at exposures to 2000 mg/kg. Well defined but slight erythema and slight oedema were observed. According to the CLP guidelines, Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts is a category 4 toxicant based on the oral results but is not classified based on dermal results.

The second read across substance (MIPA) had an oral LD50 of 2813 mg/kg to male and female rats.

As a conservative approach the values from Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts will be used for Benzenesulfonic acid, 4 -C15 -16 -sec-alkyl derivs. MIPA salt.

Justification for classification or non-classification

According to the CLP guidelines, the read across substance Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts is a category 4 toxicant based on the oral results but is not classified based on dermal results. This classification will also apply to Benzenesulfonic acid, 4 -C15 -16 -sec-alkyl derivs. MIPA salt.