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Toxicological information

Acute Toxicity: oral

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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:
other: Performed according to OECD Guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Marlopon AT 50
- Substance type: technical product
- Physical state: light brown, clear liquid
- Composition of test material, percentage of components: 50% linear alkenylbenzene sulfonate triethanolamine (LAS TEA) , 1% neutral oil, 1% triethanolamin, 3.5% treithanolaminesulfate. The rest of the product was water.
-Batch No: 2406



Test animals

Species:
rat
Strain:
other: Bor: WISW
Sex:
male/female
Details on test animals 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
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:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
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.