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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
1978
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study performed before test guidelines and GLP principles were in place. However missing information and shortcomings in description of the methods. No details on test substance (Lot/Batch number; purity).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Remarks:
Experiment was done before GLP principles were implemented.
Test type:
standard acute method
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name (as cited in test report): tetramethylammonium chloride

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: TNO in house breeding
- Age at study initiation: not described
- Weight at study initiation: males 197 - 352 g; female 105 - 200 g
- Fasting period before study: yes, overnight
- Housing: in groups of 5, in stainless steel cages
- Diet: ad libitum, stock diet
- Water: ad libitum, tap water
- Acclimation period: not necessary (in house breeding)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23-25C
- Humidity (%): not described
- Air changes (per hr): not described, "well-ventilated"
- Photoperiod (hrs dark / hrs light): not described

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 2% v/v

MAXIMUM DOSE VOLUME APPLIED: 6.2 ml/kg bw
Doses:
single doses of 0.06, 0.072, 0.086, 0.104 and 0.124 ml/kg body weight (corresponds to 30, 36, 43, 52 and 62 mg TMAC /kg bw)
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: none performed
- Necropsy of survivors performed: yes
- Other examinations performed: no
Statistics:
The LD50 was calculated according to the method of Weil (Biometrics (1952) 249-263)

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
47 mg/kg bw
Based on:
other: TMAC
95% CL:
> 41 - < 50.5
Mortality:
Deaths occurred between 1 and 18 hours after dosing.
Clinical signs:
Within a few hours after treatment the rats showed sedation, clonic convulsions and dacryorrhoea. Coma was frequently observed. The survivors recovered gradually and looked quite healthy again at the end of the observation period.
Body weight:
Not recorded.
Gross pathology:
Macroscopic examination of the survivors at autopsy did not reveal any treatment-related gross alterations.

Any other information on results incl. tables

dose

mortality

Solution

ml/kg

Test substance

(50% aqueous sol.)

ml/kg

number

%

males

females

3.0

0.060

0/5

0/5

0

3.6

0.072

0/5

1/5

10

4.3

0.086

2/5

2/5

40

5.2

0.104

2/5

5/5

70

6.2

0.124

3/5

4/5

70

Applicant's summary and conclusion

Interpretation of results:
highly toxic
Remarks:
Migrated information category 2 Criteria used for interpretation of results: EU
Conclusions:
In an oral toxicity study with rats in general according to OECD 401 (1987), the LD50 of a 50% aqueous solution of TMAC was found to be 0.094 ml/kg bw. This is equivalent to an LD50 of 47 mg/kg bw for pure TMAC. Therefore the substance is classified for oral toxicity in category 2 according to CLP Regulation (EC) 1272/2008.
Executive summary:

In an oral toxicity study with male and female rats in general according to OECD guideline 401 (1987), the rats were orally exposed to dilutions of a 50% aqueous solution of TMAC. Deaths occurred between 1 and 18 hours after dosing. Within a few hours after treatment the rats showed sedation, clonic convulsions and dacryorrhoea. Coma was frequently observed. The survivors recovered gradually and looked quite healthy again at the end of the observation period. The LD50 of the 50% aqueous solution of the test substance was found to be 0.094 ml/kg bw. This is equivalent to an LD50 of 47 mg/kg bw for pure TMAC. The substance is classified for oral toxicity in category 2 according to CLP Regulation (EC) 1272/2008.