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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study well documented, meets generally accepted scientific pinciples

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Principles of method if other than guideline:
Method: other: LD50 was calculated according to the method of Weil (Biometrics 8 (1952), 249-263)

Method similar to the (now deleted) OECD 401.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
(3-chloro-2-hydroxypropyl)trimethylammonium chloride
EC Number:
222-048-3
EC Name:
(3-chloro-2-hydroxypropyl)trimethylammonium chloride
Cas Number:
3327-22-8
Molecular formula:
C6H15ClNO.Cl
IUPAC Name:
3-chloro-2-hydroxy-N,N,N-trimethylpropan-1-aminium chloride
Details on test material:
IUCLID4 Test substance: other TS: Servon XRK 60 (no further data)

Test animals

Species:
rat
Strain:
other: SPF-bred albino rats (Cpb: WU; Wistar random)
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Central Institute for the breeding of laboratory animals, TNO, Zeist, NETHERLANDS.
- Weight at study initiation: 84-116 g (males); 76-100 g (females)
- Fasting period before study: not stated
- Housing: stainless steel cage (numer/cage not stated)
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: not stated

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 +/- 1
- Humidity (%): no data
- Air changes (per hr): 'well ventilated'
- Photoperiod (hrs dark / hrs light): no data

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: undiluted
Details on oral exposure:
VEHICLE
- Concentration in vehicle:
- Amount of vehicle (if gavage):
- Justification for choice of vehicle:
- Lot/batch no. (if required):
- Purity:


MAXIMUM DOSE VOLUME APPLIED:
Doses:
1.92, 2.30, 2.76, 3.31, 3.98 mg/kg body weight
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: weighed on days 0, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
LD50 according to: Weil (1952). Biometrics 8, 249.

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3.2 mL/kg bw
95% CL:
2.66 - 3.84
Remarks on result:
other: 60% CHPTAC
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 688 mg/kg bw
Remarks on result:
other: 60% CHPTAC
Sex:
male/female
Dose descriptor:
LD50
Effect level:
2 213 mg/kg bw
Remarks on result:
other: 100% CHPTAC
Mortality:
See Table 1 in "Any other information on results incl. tables".
Clinical signs:
No clinical signs amongst survivors.
Body weight:
No treatment-related effect on body weight.
Gross pathology:
No abnormal gross pathology.
Other findings:
None reported.

Any other information on results incl. tables

Table 1: Mortality

 Dose
(ml/kg bw)

Mortality (dead/total)

Male

Female

Combined

1.67

1/5

0/5

1/10

2.00

0/5

1/5

1/10

2.40

2/5

1/5

3/10

2.88

4/5

3/5

7/10

3.46

4/5

2/5

6/10

Death occurred within 1 h of dosing; survivors recovered and there were no overt signs of toxicity. No gross abnormalities were identified on examination.

LD50 (Servon XRK 60) = 3.20 mL/kg bw. or 3.68 g/kg bw (TS specific gravity 1.15)

Equivalent to an LD50  for 100% CHPTAC of 2213 mg/kg bw/day

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
A reliable study conducted very largely in compliance with a standard guideline but without GLP, identified an LD50 value for 60% CHPTAC of 3.20 mL/kg bw in male and female rats. This would be equivalent to an LD50 for 100% CHPTAC of 2213 mg/kg bw.
Executive summary:

In an acute toxicity study, the toxic potential of CHPTAC was tested dermally on male and female rats. A LD 50 value for 60% CHPTAC of 3.20 mL/kg bw was identified in male and female rats. This would be equivalent to an LD50 for 100% CHPTAC of 2213 mg/kg bw.