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Administrative data

Description of key information

Acute oral toxicity:
acute oral study with rats (BASF, 1971): LD50 = 950 (851 - 1062) mg/kg bw
acute oral study with rats (BASF, 1967): LD50 = 1600 mg/kg bw
acute oral study with rats (BASF, 1966): LD50 = 1400 mg/kg bw
Acute inhalative and dermal toxicity:
In accordance with column 2 of REACH Annex VIII, the test on acute dermal toxicity (required in section 8.5) does not need to be conducted as the available information show that the criteria are met for classification as corrosive to the skin (R34, skin corr. cat. 1C). In conclusion, no further testing is required in accordance with animal welfare reasons.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed

Additional information

Acute toxicity oral:

Three studies according to a BASF-internal standard protocol similar to OECD TG 401 were conducted in order to estimate the acute oral toxicity of the test item. Gross pathology was performed for all of the treated animals.

1) XXI/132, 1971

During this study 10 rats per sex and dose were treated with 640, 800, 1000, 1250, 1600, 2000, 2500 or 3200 mg/kg bw of the test item prepared as 10% aqueous emulsion with CMC. The composition of test material was reported as 60.0 % glycol sulfate, 17.9 % sulfate and 2.6 % bisulfate of C11-C14-alcyl-(CH2-CH2OH)S+, 19.5 % C11-C14-alcyl-oxethylsulfide. After application of 2600, 2000, 2500 and 3200 mg/kg bw the animals showed dyspnea, slight trembling spasms, apathy, diarrhea, secretion out of the oral cavity as well as red-agglutinated eyes and noses. Treatment with 640, 800, 1000 and 1250 mg/kg bw caused dyspnea and scretion out of the oral cavity while surviving animals did not show any clinical signs after 6 days. The animals were observed for 14 days. After 14 days the following mortality rate was observed: 640 mg/kg: 2/20, 800 mg/kg: 4/20, 1000 mg/kg: 13/20, 1250 mg/kg: 16/20; 1600, 2000, 2500, and 3200 mg/kg: 20/20. Gross pathological findings were only observed for animals that died during the study and implied intestine atony, diarrhea, general venous congestion. The LD50 of 950 mg/kg bw was calculated using the method of LITCHFIELD-WILCOXON.

2) XVII/299, 1967

During this study 10 rats per dose level were treated with 2, 10, 20 and 30% emulsions of the test item in water resulting in doses of 200, 1250, 1600, 3200, and 6400 mg/kg bw. The analytical purity of the test item was 50%. The animals were observed for 7 days while dyspnea and apathy were reported. After 7 days the following mortalities were detected: 200 mg/kg: no deaths, 1250 mg/kg: 2/10, 1600 mg/kg: 5/10, 3200 and 6400 mg/kg: 10/10. The only gross pathology finding was diarrhea and the LD50 was estimated to be 1600 mg/kg bw.

3)XVI/209, 1966

During this study 10 rats per dose level were treated with 2, 8, 16 and 30% emulsions of the test item in water resulting in doses of 200, 800, 1000, 1250, 1600, 2000, and 3200 mg/kg bw. The purity of the test item was 90%. The animals were observed for 7 days while the following clinical signs were reported: Excitation, staggering, dyspnea, diarrhea. Diarrhea was also found during gross pathology. Based on the following mortalities an LD50 of 1400 mg/kg bw was estimated: 200 mg/kg: no deaths, 800 mg/kg: 1/10, 1000 mg/kg: no deaths, 1250 mg/kg: 2/10, 1600 mg/kg: 8/10, 2000 mg/kg: 9/10, 3200 mg/kg: 10/10.

Justification for classification or non-classification

The test item is harmful after oral administration (EU: R22; GHS acute oral cat. 4, H302) according to the criteria of EU Directive 67/548/EEC and EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No 1272/2008.