Registration Dossier

Administrative data

Description of key information

Acute toxicity data indicate low toxicity of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with triethanolamine: in rats the oral LD50 was 2928 mg/kg bw; and in rabbits the dermal LD50 for both TEA and LAS Na was > 2000 mg/kg bw. 

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
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.
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
no
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

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.
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

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

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.

 

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
2 925 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw
Quality of whole database:
The dermal LD50 is higher than 2000 mg/kg bw.

Additional information

Oral toxicity

LAS TEA:

In an acute oral toxicity test, Marlopon AT50 (50% linear alkenylbenzene sulfonate triethanolamine -LAS TEA- , 1% neutral oil, 1% triethanolamin, 3.5% triethanolamine sulfate, water) was given by gavage to rats at single doses of 3980, 5010, 6310, 10000 mg/kg bw, corresponding to 2211,2783, 3506, 5556 mg active ingredient/kg bw.The oral LD50  for CAS 68411 -31 -4 is 2925 mg/kg  bw.

Supporting information

LAS Na:

A study comparable to OECD guideline 401 found an acute oral LD50 of 1080 mg/kg.

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.

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 IV toxicant (H302: Harmful if swallowed) at concentrations equal to or greater than 65%, while it is not classified at lower concentrations.

TEA:

In an acute oral toxicity study (BASF AG, 1966), 5 Sprague-Dawley rats/sex/dose were exposed to 200 - 6400 mg/kg bw TEA by gavage and observed for 7 days. The LD50 was determined to be 6400 mg/kg bw for males and females. No deaths occurred at doses of 5000 mg/kg bw or below. At 200 mg/kg bw, slight agitation was observed up to 4 hours after exposure; at higher doses unsteady, elevated respiration, anancasm to chew, apathy, and reduced grooming was noticed. Two days after exposure, no clinical signs were observed. Gross pathology did not reveal any abnormalities.

Dermal toxicity

TEA:

In a dermal limit test, rabbits were treated with 2000 mg/kg bw TEA on the intact or abraded skin and subsequently observed for a 14 -day period (EPA, 1989a). The test substance was either derived from NH3(92% TEA) or DEA (88% TEA), both containing approximately 6.5% DEA. Mild erythema was observed following exposure to TEA derived from NH3on the intact or abraded skin, returning to normal on day 6. Moderate erythema was observed following exposure to TEA derived from DEA on the intact or abraded skin, returning to normal on day 10. No mortality was observed, hence the LD50 was > 2000 mg/kg bw.

LAS Na:

The clipped skin on the backs of five male and five female rats were exposed to LAS Na 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.

Based on the read across approach, the dermal LD50 for Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with triethanolamine will also be higher than 2000 mg/kg bw.

Such results demonstrate that TEA is much less acutely toxic than LAS TEA, while LAS Na is more potent than LAS TEA. Comparison of LAS TEA (LD50= 2925 mg/kg bw) and LAS Na endpoints shows that the toxicity of both compounds, expressed on a molar basis can be considered comparable; the difference is within a factor of 2. This is well within the normally expected variability in toxicity testing and is not expected to be of any toxicological significance.


Justification for selection of acute toxicity – oral endpoint
Guideline, Klimisch 2 study, performed with LAS TEA.

Justification for selection of acute toxicity – inhalation endpoint
According to REACH Regulation substances other than gases shall be tested through one more route except for the oral for acute toxicity (inhalation or demal). The dermal route was considered more appropriate for Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with triethanolamine, and therefore the requirement for acute inhalation toxicity is waived. An acute dermal toxicity is available for triethanolamine (TEA), and is used with a read-across approach to predict the acute dermal toxicity potential of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with triethanolamine.

Justification for selection of acute toxicity – dermal endpoint
Weight of evidence approach applied.

Justification for classification or non-classification

Based on the results of acute oral and dermal toxicity studies, LAS TEA does not need to be classified according to the EU Regulation (EC) 1272/2008.