Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Acute toxicity of the test item is addressed by read-across approach. Based on experimental data available for all source substances, lowest LD50 of 1080 mg LAS Na/kg bw/ was obtained in rats via the oral route. Via the dermal route no adverse effects were observed at doses up to 2000 and 13000 mg/kg bw tested with LAS Na and DEA, respectively.

Key value for chemical safety assessment

Acute toxicity: via oral route

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

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
discriminating dose
Value:
2 000 mg/kg bw

Additional information

No experimental data on acute toxicity is available for the test item. However, experimental data for three source substances is available and a read-across approach is applied. Please refer to read-across justification document attached in IUCLID Section 13. Furthermore, only key studies are taken into account here. For further supporting information please refer to respective REACH registration dossier of each source substance.

Oral

CAS 121617 -08 -1

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 LD50in 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.

 

CAS 68411 -30 -3:

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.

CAS 111 -42 -2

Regarding the oral route of exposure, in a study (BASF AG, 1966), performed to a comparable protocol as OECD guideline 401, 5 rats per sex were dosed with 200 - 3200 mg/kg bw and observed up to 14 days. No deaths occurred up to 1000 mg/kg bw dosing group. The LD50 for males and females combined was 1600 mg/kg bw. Reported clinical signs were tumbling, staggering gait, twitches, convulsions, dyspnoea, abdominal lateral position and scrubby coat. Gross pathology revealed hydrothorax, local adhesions of the gut and signs of irritation on the gastro-intestinal tract.

Inhalation

In accordance with column 2 of REACH Annex VIII, in addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. As acute dermal toxicity studies for read-across substances are available, no acute inhalation toxicity study is needed.

Dermal

CAS 68411 -30 -3

A GLP and OECD 402 compliant study was conducted with CAS 68411-30-3. 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.

CAS 111 -42 -2

Two secondary literature sources are available for acute dermal toxicity with CAS 11 -42 -2. Rabbits were exposed to the substance for 24 h under occlusive dressing. Value was given as 11.89 mL/kg and LD50 was calculated to be 13000 mg/kg bw with the specific density of 1.1 g/cm^3 published for this substance. No further data was given.

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data of three source substances are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008, applying a read-across approach. The oral LD50 was determined to be 1080 mg/kg bw and 1100 mg/kg bw for source substance 2 and 3, respectively. Therefore, and equivalent to both source substances, the test item is classified for acute oral toxicity cat 4 (H302: "harmful if swallowed") under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.

Categories Display