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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)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
no
Principles of method if other than guideline:
Adult laboratory rats were purchased from a breeder. Usually the source and strain of the animals were not documented. Several groups of 5 rats per sex and dose were treated simultaneously by gavage with preparations of the test substance in a suitable vehicle. The concentrations of these preparations were usually adjusted to achieve comparable volumes (e.g. 10 ml) per kg body weight.
Group-wise documentation of clinical signs was performed over the 14- day study period. Body weight was determined before the start of the study only, as it was needed for determination of dose. The clinical signs and findings were reported in summary form. More details e.g. on substance preparation, or dose and time dependence of symptoms, can be inferred from the German hand written raw data.
On the basis of the observed lethality, the LD50 value was determined by probit analysis.
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Reference substance name:
stearic acid chloride
IUPAC Name:
stearic acid chloride
Details on test material:
- Name of test material (as cited in study report): Stearinsäurechlorid
- Substance type: substance
- Physical state: liquid
- Analytical purity: 99 %
- Molecular weight: 302,5
- Desity: 0.95

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
olive oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100%, 76,6%, 43 %, 20 %, 9,3 %
- Justification for choice of vehicle: low toxicity, stability and soulubility of the test subsance

MAXIMUM DOSE VOLUME APPLIED:
1,56 ml

Doses:
464, 1000, 2150, 3830, 5000, 6810, 8250 mg/kg
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:
Observations: <15 min; 15 min 30 min, 1 h, 2 h, 4 h, 5 h post administration on the day of administration , once daily thereafter except on weekends and holidays
Weighing: prior to administration, on day 7 and at termination of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Statistics:
Probit analysis

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
5 783 mg/kg bw
95% CL:
>= 5 047 - <= 6 570
Mortality:
no mortality occorred in doses up to 3830 mg/kg (details see table below)
Clinical signs:
Apathy, ataxia, tremor, irregular respiration, abdominal posture, poor general condition (details see table below)
Body weight:
Overall body weight development was positiv in all groups (details see table below)
Gross pathology:
5000, 6810, 8250 mg/kg: stomach ulcer, bloody stomach, necrotic stomach mucosa, diarrhea
464, 1000, 2150, 3830 mg/kg: nothing abnormal detected

Any other information on results incl. tables

Dose

[mg/kg]

Mortality

Clinical observation

       

Mean body weight

[g]                

8250

5/5 male     5/5 female

Apathy, ataxia, tremor, irregular respiration, abdominal posture, poor general condition

Beginning: 180 g (male) ;    160 g (female)

Day 7: -

Day 14: -

6810

3/5 male     3/5 female

Apathy, ataxia, tremor, irregular respiration, poor general condition

Beginning: 190 g (male) ;   160 g (female)

Day 7:      210 g (male) ;   186 g (female)

Day 14:     238 g (male) ;   203 g (female)

5000

1/5 male     2/5 female

Apathy, ataxia, irregular respiration, poor general condition

Beginning: 230 g (male) ;   180 g (female)

Day 7:      254 g (male) ;   205 g (female)

Day 14:     260 g (male) ;   230 g (female)

3830

0/5 male     0/5 female

Nothing abnormal detected

Beginning: 190 g (male) ;   160 g (female)

Day 7:      255 g (male) ;   188 g (female)

Day 14:    295 g (male) ;   199 g (female)

2150

0/5 male     0/5 female

Nothing abnormal detected

Beginning: 200 g (male) ;   170 g (female)

Day 7:      269 g (male) ;   211 g (female)

Day 14:     301 g (male) ;   226 g (female)

1000

0/5 male     0/5 female

Nothing abnormal detected

Beginning: 200 g (male) ;   170 g (female)

Day 7:      247 g (male) ;   209 g (female)

Day 14:     298 g (male) ;   219 g (female)

464

0/5 male     0/5 female

Nothing abnormal detected

Beginning:  210 g (male) ;  170 g (female)

Day 7:       275 g (male) ;  208 g (female)

Day 14:     300 g (male) ;  219 g (female)

Applicant's summary and conclusion

Executive summary:

The study is comparable to OECD Guideline 401 with acceptable restrictions (partly limited documentation, e.g. only

mean bodyweight reported). Groups of 5 male and 5 female rats were gavaged at dose levels of 464, 1000, 2150, 3830, 5000, 6810 and 8250 g/kg bw. The post-exposure observation period was 14 days. Clinical signs like tremor, apathy, unsteady respiration were observed 1 h until day 1 after administration. No death occurred at concentrations up to 3850 mg/kg. The LD50 value is 5783 mg/kg. Therefore, the testsubstance is considerd to be relatively harmless after oral administration.

Conclusion

No death occurred at concentrations up to 3850 mg/kg. The LD50 value is > 5000 mg/kg. Therefore the test substance is considerd to be relatively harmless after oral administration.