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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
From 1972 to 1973
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test performed before OECD and GLP guidelines. Important aspects (14 day-postobservation time) in line with current OECD guidelines.
Justification for type of information:
Refer to the Quaternary ammonium salts (QAS) category or section 13 of IUCLID for details on the category justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Acute oral toxicity after single application
GLP compliance:
no
Remarks:
Performed before GLP guidelines
Test type:
standard acute method
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Hoechst
- Age at study initiation: no data
- Weight at study initiation: 82-104 g (mean 93 g )
- Fasting period before study: 16 h
- Housing: in plastic cages
- Diet (e.g. ad libitum): Standard Altromin R, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS: no data
Route of administration:
oral: gavage
Vehicle:
other: sesame oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 %
- Amount of vehicle (if gavage): dependent on dose, not constant
- Justification for choice of vehicle: not given

MAXIMUM DOSE VOLUME APPLIED: 50 mL/kg
Doses:
800, 1250, 2000, 3200, and 5000 mg/kg
No. of animals per sex per dose:
10 females per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing once per week
- Necropsy of survivors performed: unclear from report
- Other examinations performed: body weight, no further information
Statistics:
LD50 was calculated using Probit analysis
Preliminary study:
No sex differences were observed in preliminary study, therefore only females were used in the main study
Key result
Sex:
female
Dose descriptor:
LD50
Effect level:
3 190 mg/kg bw
Remarks on result:
other: not classified
Mortality:
The following number of deaths were observed per dose group:

dose (mg/kg) -- number of death animals -- number of total animals
800 -- 0 -- 10
1250 -- 0 -- 10
2000 -- 1 -- 10
3200 -- 5 -- 10
5000 -- 10 -- 10
Clinical signs:
other: Not reported
Gross pathology:
Uunclear if done
Interpretation of results:
other: CLP criteria not met
Remarks:
(not classified)
Conclusions:
Based on the results of the read across study, the acute oral LD50 of the substance in rats is considered to be 3190 mg/kg bw.
Executive summary:

A study was conducted to determine the acute oral toxicity of the read across substance, C20-22 TMAC (active: 96.6%), according to a method similar to OECD Guideline 401 (standard acute method). Group of 10 female wistar rats each were administered read across substance at doses of 800, 1250, 2000, 3200 and 5000 mg/kg bw by oral gavage. Following administration, the animals were observed for 14 d and mortality and body weights were recorded daily. Dose dependant mortality was observed at the end of the study. Under the study conditions, the acute oral LD50 of the substance in rats was determined to be 3190 mg/kg bw (Scholz and Weigand, 1973). Based on the results of the read across study, similar oral LD50 is expected for the test substance, C18-22 TMAC.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
3 190 mg/kg bw
Quality of whole database:
Good quality study.

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

Oral:

A study was conducted to determine the acute oral toxicity of the read across substance, C20-22 TMAC (active: 96.6%), according to a method similar to OECD Guideline 401 (standard acute method). Group of 10 female wistar rats each were administered read across substance at doses of 800, 1250, 2000, 3200 and 5000 mg/kg bw by oral gavage. Following administration, the animals were observed for 14 d and mortality and body weights were recorded daily. Dose dependant mortality was observed at the end of the study. Under the study conditions, the acute oral LD50 of the substance in rats was determined to be 3190 mg/kg bw (Scholz and Weigand, 1973).Based on the results of the read across study, similar oral LD50 is expected for the test substance, C18-22 TMAC.

Dermal:

The acute dermal toxicity testing is not needed as the substance does not meet the criteria for classification for acute toxicity and STOT SE for the oral route (based on the above read across study). This is also supported by the absence of any systemic effects in the in vivo skin irritation/sensitisation studies available with the read across substances, C20-22 TMAC and C18 TMAC respectively. Moreover, given the physico-chemical properties and ionic nature of the test substance, the dermal LD50 value is less likely (due to lower absorption potential of dermal route) to be lower than oral LD50 or the oral doses showing clinical signs. Hence, testing via dermal route will less likely result in any additional hazard identification and testing is therefore considered unnecessary.

Inhalation:

The substance has a low vapour pressure (see physico-chemical properties section) at room temperature. Due to this it is unlikely that this substance will form inhalable dust, mist or fumes during normal processing and use conditions. In case inhalable forms of the substance are created under particular conditions (e.g. spraying, elevated temperature/pressure), appropriate risk management measures such as closed systems, exhaust ventilation or wearing of respirators are implemented to control exposure. Under such conditions, the risk to humans following inhalation exposure can be considered minimal and further testing involving vertebrate animals may be omitted, in accordance with Annex XI (1.2) of the REACH regulation.

Justification for classification or non-classification

Based on the results of the read across acute oral toxicity study together with physico-chemical properties (indicating low absorption potential), the test substance, C18-22 TMAC, does not warrant classification for acute oral or dermal toxicity, according to the EU CLP (Regulation 1272/2008/EC).