Registration Dossier

Administrative data

Description of key information

oral: OECD 401, rat LD50 > 200 < 2000 mg/kg bw

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
adverse effect observed
Dose descriptor:
discriminating dose
200 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 study available

Additional information

Acute oral toxicity

In accordance with column 2 of REACH Annex VIII, testing of the acute toxicity is not appropriate as the target substance is classified as corrosive to the skin. However, two acute oral toxicity studies have already been conducted in 1987 and 1990. The key study, which is equivalent or similar to OECD Guideline 401, is summarized below (Henkel KGaA, TBD 981004, 1990).

The test substance was administered at concentrations of 200 and 2000 mg/kg bw by gavage to groups each 5 male and female Wistar rats. The observation period of 14 days included daily observations for clinical signs and mortality, and weighing the day before and on the day of application, as well as on days 2, 7 and 14. Necropsy of all animals was performed.

None of the animals exposed to 200 mg/kg bw died up to the end of the 14 day observation period. Only one male animal had to be sacrificed 52 hours post dosing, but this was due to a gavage error. No clinical signs could be observed and all animals showed a normal body weight gain.

4 male animals and all 5 female animals died within 30 hours after application of 2000 mg/kg bw. The fifth male animal died 48 hours after application. Onset of clinical signs was already 15 minutes after dosing for male animals and 2.5 hours for females. Severity of symptoms increased up to death of the animals. Clinical signs included: vocalization, piloerection, diarrhea, decreased activity, squatting posture which changed to belly-side location and belly location at later time points, brownish colored nose and/or snout and lid closure.

Gross pathology revealed no abnormal findings for the animals dosed with 200 mg/kg bw. Animals dosed with 2000 mg/kg bw showed the following pathological findings:

2 male and 5 female animals dosed with 2000 mg/kg bw showed a severe gaseous distention of the small intestine and the females additionally of the stomach. 1 female animal had a red discolored glandular stomach and the duodenum filled with liquid. 2 male animals and all 5 female animals showed a severe hydrothorax, 2 male animals had redness of the fundus area and moderate ascites. Additionally, 1 male animal had a filled small intestine, slight ascites and a slight hypothorax. The effects described, which occurred at the site of contact, could be interpreted as consequence of the corrosive potential of the test substance.

In conclusion, the LD50 was set to be > 200 < 2000 mg/kg bw and therefore Quarternary ammonium compounds, tri-C8 -10 -alkylmethyl, chlorides, needs to be classified as toxic (Cat.3, H301) according to CLP Regulation (EC) No. 1272/2008 (worst case) and (Xn, R22) according to DSD (67/548/EEC).

Acute inhalation toxicity:

In accordance with column 2 of REACH Annex VIII, testing of the acute toxicity is not appropriate as the substance is classified as corrosive to the skin.

Acute dermal toxicity:

In accordance with column 2 of REACH Annex VIII, testing of the acute toxicity is not appropriate as the substance is classified as corrosive to the skin.

Justification for classification or non-classification

Based on the results for acute oral and acute dermal toxicity, the substance needs to be classified according to the:

- Dangerous Substance Directive 67/548/EC - Xn, R22

- CLP Regulation (EC) No 1272/2008 - Cat.3, H301