Registration Dossier

Administrative data

Description of key information

Oral toxicity

LAS TEA:

In a reliable acute oral toxicity test conducted according to OECD 401, the substance was dosed 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 the substance is 2925 mg/kg bw.

Supporting information on analogues

LAS Na:

A study comparable to OECD 401 examined the oral toxicity of the substance in rats. Groups of 5 male and 5 female rats were exposed orally to 0, 1075, 1220, 1360, or 1710 mg/kg. The acute oral LD50 was demonstrated to be 1080 mg/kg.

Note: Other 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 main study. The effects and symptoms observed with the main study for the test substance were also observed in the other studies. 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. The substance is classified as Category 4 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

There is no acute dermal study on the substance and read-across is used from two analogue substances.

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.

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.

Based on the read across from the two analogue studies, the dermal LD50 for LAS TEA 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.


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
Study period:
19th July 1984 - 8th August 1984
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 as active ingredient 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.
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 925 mg/kg bw
Based on:
act. ingr.
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:
GHS criteria not met
Conclusions:
The acute oral LD50 for the active material (CAS 68411-31-4) in the rat 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% triethanolamine, 3.5% trethanolamine sulfate, water) at doses of 3980, 5010, 6310, 10000 mg /kg bw mg/kg bw (equivalent to 2211, 2783, 3506, 5556 mg/kg bw active ingredient) and observed for 14 days.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. The acute oral LD50 for the active material (CAS 68411-31-4) in the rat is 2925 mg/kg bw and hence, the substance shall not be classified for acute oral toxicity.

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
LD50
Value:
2 925 mg/kg bw
Quality of whole database:
One reliable study on the substance itself and two supporting studies on analogues.

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records

Referenceopen allclose all

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: read-across to Klimisch 1 GLP laboratory study
Qualifier:
according to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
yes (incl. certificate)
Test type:
standard acute method
Limit test:
yes
Species:
rat
Strain:
other: CFY (remote Sprague Dawley origin)
Sex:
male/female
Details on test animals and environmental conditions:
Rats were in a weight range of 210 to 239 g prior to dosing on day 1 and approximately six to eight weeks of age. All the rats were acclimated to the experimental environment for a period of 15 days prior to study initiation. Animals were housed in individual metal cages with wire mesh floors. Standard diet and water were provided ad libitum. Each animal was identified by cage number and ear punching.
Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Test material was a yellow viscous liquid and was applied to an area clipped with electric clippers (approximately 10% of the area) on the backs of 10 rats (five male, five female) at a dose of 2000 mg/kg. The areas were covered with gauze held in place with an impermeable plastic dressing. At the end of 24 hours the dressings were carefully removed and the treated area of skin washed in warm water and blotted dry with absorbent paper.
Duration of exposure:
24 hr
Doses:
2000 mg/kg (undiluted)

No. of animals per sex per dose:
5 male and 5 female
Control animals:
not specified
Details on study design:
Animals were observed soon after dosing and then at frequent intervals for the remainder of day 1. On subsequent days the animals were observed once in the morning and again at the end of the experimental day. The treated areas were examined daily for signs of dermal irritation and assessed according to the standard scoring system for erythema, eschar and oedema. All animals were observed for 14 days after dosing. On day 15 all animals were sacrificed and given a macroscopic post-mortem examination of internal organs.
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:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
date of report: July 30, 1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes
Species:
rabbit
Strain:
not specified
Sex:
not specified
Type of coverage:
not specified
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
intact and abraded skin was tested
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 animals tested with intact skin and 3 animals tested with abraded skin with DEA-derived and NH3-derived TEA each (12 animals in total)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: no data
- Other examinations performed: clinical signs, body weight
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
TEA derived from NH3 (intact): 0/3
TEA derived from NH3 (abraded): 0/3
TEA derived from DEA (intact): 0/3
TEA derived from DEA (abraded): 0/3
Clinical signs:
TEA derived from NH3: mild erythema at 24 hrs (intact and abraded skin) returning to normal on day 6
TEA derived from DEA: moderate erythema at 24 hrs (intact and abraded skin) returning to normal on day 10
Body weight:
all animals showed body weight gain during the course of the study
Gross pathology:
No data
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of this test the dermal LD50 of TEA in the rabbit is higher than 2000 mg/kg bw.
Executive summary:

In this 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 NH3 on 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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw
Quality of whole database:
The endpoint is based on a weight of evidence assessment using data from two analogues.

Additional information

Justification for classification or non-classification

Based on the results of the available studies conducted by the oral and dermal routes, the substance is not classified for acute toxicity.