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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
Study period:
From 1983-11-16 to 1983-11-30
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study including statement that the report and the study were audited by the Quality Assurance Unit of the testing laboratory.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
but a statement that the report and the study were audited by the Quality Assurance unit is included.
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Hacking and Churchill Limited, Huntingdon, UK
- Age at study initiation: four to six weeks of age
- Weight at study initiation: 87 to 108 g
- Fasting period before study: overnight prior and approximately 4 hours after dosing.
- Housing: in groups by sex in metal cages with wire mesh floors
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days prior to the start of the main study

ENVIRONMENTAL CONDITIONS
- Temperature : 23 to 24 °C
- Humidity: 47 %
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12hr/12hr

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: methylcellulose
Details on oral exposure:
VEHICLE
- Concentration in vehicle: the test item was prepared as a 50 % w/v suspension in 1% methylcellulose.
- Amount of vehicle (if gavage): dose volumes were calculated from the body weights of the rats and the selected dose volume did not exceed 10 ml/kg body weight.

Doses:
5000 mg/kg bw.
No. of animals per sex per dose:
5 rats/sex/dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days.
- Frequency of observations and weighing: at frequent intervals on day 1 (day of dosing) then at least twice a day, weighing at 1, 8 and 15 days after exposure.
- Necropsy of survivors performed: yes.

Statistics:
none

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw
Remarks on result:
other: expressed as Arquat 2HT-75 (a 75% dilution)
Mortality:
No deaths were observed during the study.
cf table 1 in results and discussions free text
Clinical signs:
- In all animals, piloerection, pallor of the extremities and hunched posture were observed from day 1 to day 4 (recovery complete by day 4).
- In all females and 2 males, abnormal gait was observed from day 1 to day 4 (recovery complete by day 4).


Body weight:
The average body weight gain for each group was within the normal limits for rats of the age sex and strain used in this study.
cf table 2 in results and discussions free text
Gross pathology:
No abnormalities were detected at autopsy.

Any other information on results incl. tables

Summarized results:

Table 1:Summarized results of cumulative mortality by sex

Acute oral toxicity, limit test, cumulative mortality
Day Dose (mg/ kg bw) Sex Dose (mg/ kg bw) Sex
5000 F 5000 M
Cumulative mortality Cumulative mortality
1 0/5  0/5
2  0/5  0/5
3  0/5  0/5
4  0/5  0/5
5  0/5  0/5
6  0/5  0/5
7  0/5  0/5
8  0/5  0/5
9  0/5  0/5
10  0/5  0/5
11   0/5  0/5
12  0/5  0/5
13  0/5  0/5
14  0/5  0/5
15  0/5  0/5

Table 2:Summarized results for body weight


Acute oral toxicity, limit test, 5000 mg/kg bw
 Sex  Mean body weight in grams
Day 1 Day 8 Day 15
 M   105 178 255
 M   103 186 272
M   95 177 255
 M   93 163 239
 M   107 188 250
 F  90 142 174
 F   87 142 189
 F   102 161 203
 F 107 161 200
 F 108 169 206
   

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: other: CLP (Reg. 1272/2008/EC) and Directive 67/548/EEC
Conclusions:
Based on this study, the acute oral LD0 of the 75% dilution of the substance is equal to or greater than 5000 mg/kg bw. According to the criteria laid down in CLP (Reg 1272/2008/EC) and directive 67/548/EEC, the tested substance is not classified.


Executive summary:

The objective of this study was to evaluate the toxicity of a 75% dilution of the test item ( DHTDMAC 75% active in isopropanol/water)

following a single oral administration in rats according to OECD guideline 401. A statement that the report and the study were audited by the Quality Assurance Unit of the testing laboratory was provided.

the test material was prepared in 1% methylcellulose suspension and was administered by gavage under a dosage-volume of 10 ml/kg bw to 2 groups of 5 male and 5 female rats.

Based on a preliminary study indicating no deaths in 2 males and 2 female rats at 5000 mg/kg bw, the main experiment was performed at the limit dose level of 5000 mg/kg bw.

Clinical signs, mortality and body weight were checked for a period of 14 days following the single administration of the test item. All animals were subjected to necropsy.

At the dose-level of 5000 mg/kg, no mortality and no effects on body weight gain were observed. Piloerection, pallor of the extremities and hunched posture were observed in all animals from day 1. Abnormal gait was also recorded in 2 out of 5 males and 5 out of 5 females. Recovery was complete by day 4. At necropsy, there were no apparent abnormalities.

Under these experimental conditions, the oral LD0 of the 75% dilution of the substance is equal to or greater than 5000 mg/kg bw.