Benzenesulfonic acid, mono-C10-13-alkyl derivs., compds. with diethanolamine

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study without detailed documentation

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with triethanolamine

EC Number:

939-464-2

Cas Number:

121617-08-1

IUPAC Name:

Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with triethanolamine

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 2406

Test animals

Species:

rat

Strain:

other: Bor: WISW

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: F. Winkelmann, Borchen, Germany
- Weight at study initiation: males 144 g and females 117 g
- Housing: 1-5 animals in Makrolon cages Type III
- Diet: ad libitum
- Water: ad libitum, tap water
- Acclimation period: 4-8 days

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

No data

Doses:

3980, 5010, 6310, 10000 mg Marlopon AT50/kg bw (since the CAS 68411-31-4 is the 55.5 % in the technical product, the corresponding doses were: 2209, 2781, 3502, 5550 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: The animals were weighed before treatment, on days 1, 7 and 14, post-treatment
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs (6 hours after treatment and daily during the observation period)

Statistics:

LD50 determination according to Litchfield and Wicoxon (1949), including 95 % confidence intervals.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

2 925 mg/kg bw

Based on:

other: CAS 68411-31-4

Mortality:

Yes. Mortality rates can be found in the table below section 'any other information on results inl. tables'.

Clinical signs:

Yes; observed approximately half to two hours after administration of the test material: Sedation, ataxia, hypothermia, diarrhoea, cowering posture, tremor, horrent fur , dyspnoea, ventral position (temporarily) and diuresis. The symptoms dissappeared within 72 hours after treatment.

Body weight:

No effects observed.

Gross pathology:

Post mortem examinations revealed hyperaemia of mucous membranes of the GI tract in some animals; mucous membranes were partially pale.The GI tract contents were thin, foamy and slimy, partially showing yellow-orange or red-brownish discolouration. Some animals showed tympanites of stomach and intestine. Furthermore, the intestinal mucous membrane showed convulsion and hyperaemia in some animals.

Other findings:

- Organ weights: not examined
- Histopathology: no data

Any other information on results incl. tables

Table 1: Acute oral toxicity of LAS TEA on rats

Dose (mg test material /kg bw)	Dose (mg active ingredient/kg bw)	Sex	Toxicological result*
3980	2209	Male	0/5/5
		Female	0/5/5
5010	2781	Male	1/5/5
		Female	4/5/5
6310	3502	Male	4/5/5
		Female	4/5/5
10000	5550	Male	5/5/5
		Female	5/5/5

*Number of animals died/with symptoms/used

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Under the conditions of this test the LD50 for the active material (CAS 68411-31-4) is 2925 mg/kg bw and hence, the substance shall not be classified for acute oral toxicity.

Executive summary:

In an acute oral toxicity study 4 groups of young female and male Bor: WISW rats were given a single oral dose of Marlopon AT 50 (50% LAS TEA, 1% neutral oil, 1% triethanolamin, 3.5% treithanolaminesulfate, water) at doses of 3980, 5010, 6310, 10000 mg /kg bw mg/kg bw (dry material concentrations (CAS No 68411 -31 -4): 2211,2783, 3506, 5556 mg/kg bw) and observed for 14 days.

Oral LD₅₀ Combined =  2925 mg dry material/kg  bw

The dry material CAS 68411 -31-4 is of low toxicity based on the LD₅₀ in males and females. No classification and labelling for acute oral toxicity are required.                                                                                

Treatment with the test product resulted in the following clinical signs that were observed approximately half to two hours after administration of the test material: sedation, ataxia, hypothermia, diarrhoea, cowering posture, tremor, horrent fur, dyspnoea, ventral position (temporarily) and diuresis. The symptoms dissappeared within 72 hours after treatment. Post mortem examinations revealed hyperaemia of mucous membranes of the GI tract in some animals; mucous membranes were partially pale. The GI tract contents were thin, foamy and slimy, partially showing yellow-orange or red-brownish discolouration. Some animals showed tympanites of stomach and intestine. Furthermore, the intestinal mucous membrane showed convulsion and hyperaemia in some animals. No effects were observed at the lowest dose tested.