Reaction product of propargyl chloride and sodium bisulfite

Endpoint summary

Description of key information

oral: LD50 > 6000 mg/kg bw (rats)

dermal: LD50 > 5000 mg/kg bw (rats)

intraperitoneal: LD50 > 5000 mg/kg bw (mouse)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

6 000 mg/kg bw

Quality of whole database:

study similar to OECD TG 401

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:

5 000 mg/kg bw

Quality of whole database:

GLP study according OECD TG 402

Additional information

Oral

A study similar to OECD TG 401 was conducted to assess the oral acute toxicity of the test item. Female rats were administered by gavage with 1,10 or 20 % of the test item diluted in water. The following concentrations were tested: 20, 79, 316, 1260, 5010, 7940 and 10000 mg/kg bw. After administration animals were observed for a period of 7 days. Clinical signs and mortality were recorded. Gross pathology was performed. 

No mortality was observed up to 1260 mg/kg bw and no clinical signs were detected in these dose groups. In the 5010 mg/kg bw dose group 1/5 animals died and diarrhea was observed in one animal. In the 7940 and 10000 mg/kg bw dose groups, 2/2 animals died after 7 days. In the 7940 mg/kg bw dose group diarrhea was reported and in the highest dose group staggering, trembling as well as vigorous mucous diarrhea were detected. In gross pathology of animals dosed with 10000 mg/kg bw the stomach was filled with clear aqueous content and the mucosa of the adenoid parts was detached. The region of the forestomach was without findings. The approximate LD50 was ca. 6000 mg/kg bw (BASF SE VIII/82; 1958).

Dermal

In a study according OECD TG 402 the acute dermal toxicity of the test item was assessed in a Limit Test. Wistar rats (5 males and 5 females) were dermally exposed to a single dose of 5000 mg/kg bw (dose adjusted to a purity of about 31.7%, applied dose of 15773 mg/kg bw) of the undiluted test item. The clipped application site was covered by a semi-occlusive dressing during the 24 hour exposure period. After removal of the semi-occlusive dressing and washing with water, animals were observed for 14 days. Neither mortality nor signs of systemic toxicity or local skin effects were observed in the animals. The body weight of all animals increased within the normal range throughout the study period. Accordingly, the LD50 was determined to be > 5000 mg/kg bw (dose adjusted to purity) (BASF SE 11A0178/16X166, 2017).

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. As a result the substance is not considered to be classified for acute toxicity under Regulation (EC) No 1272/2008, as amended for the tenth time in Regulation (EU) No 2017/776.