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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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
(At test ending, the survivors were not subjected to necropsy and pathological examination. )
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
- Physical state: red powder
- Analytical purity: no data
- Lot/batch No.: 7/83
- No further data provided
Specific details on test material used for the study:
- Physical state: red powder
- Analytical purity: no data
- Lot/batch No.: 7/83
- No further data provided

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: CERJ, 53940 Le Genest.
- Weight at study initiation: 220 - 250 g for males; 170 - 200 g for females
- Fasting period before study: yes, 18 hours
- Housing: 10 animals per cage (Makrolon SAFI cages, 60 x 40 cm)
- Diet (e.g. ad libitum): UAR A04 Diet, ad libitum
- Water (e.g. ad libitum): Tap water, ad libitum
- Acclimation period: not specified

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 21 °C
- Humidity (%): 40 - 60 %
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12 hrs/12 hrs

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
- Concentration in vehicle: 25 g of test material in 100 mL vehicle
- Application volume:: 2 mL/100 g body weight
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
yes
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: the animals were continuously observed for mortality and clinical symptoms; body weights were recored at test initiation (prior to treatment), on day 7 and on day 14 of observation.
- Necropsy and pathological examination were scheduled for animals found dead during the first 8 hours following treatment.
- No necropsy of survivors was scheduled.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: neither mortality nor clinical signs indicative of toxicity were observed during the 14-day observation period.
Mortality:
All animals survived.
Clinical signs:
Immediately following application, piloerection and apathy were observed; these symptoms however disappeared rapidly during the course of the observation period.
Body weight:
Body weight change in the course of the study was inconspicuous.
Gross pathology:
Since no animal died, no necrospy and thus, no gross pathology was conducted.

Any other information on results incl. tables

 Mean body weight recorded for male and female Wistar rats following single gavage with 5000 mg/kg bw of the test material:

Animals (N = 5/sex)

Day 0

Day 7

Day 14

Males

Treated

218.5 g

265.5 g

284 g

Untreated*

231 g

267 g

290 g

Females

Treated

177 g

206 g

209 g

Untreated*

190 g

207 g

207 g

Untreated*, vehicle only

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information