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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:
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

Reference
Name:
Unnamed
Type:
Constituent
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 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.