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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 12 FEB 1985 to 6 MAR 1985
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Basic data given: comparable to guidelines Read-across hypothesis: for details please see read-across report in IUCLID section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985
Report date:
1985

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
yes
Remarks:
: substance composition or purity not stated
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: A. Tuck & Sons Limited, Battlesbridge, UK
- Age at study initiation: 4 to 6 weeks
- Weight at study initiation: males: 128-146 g, females: 127-139 g
- Fasting period before study: overnight
- Housing: in polypropylene cages with sawdust bedding in groups of five by sex
- Diet: standard laboratory rodent diet (Rat & Mouse Expanded Diet No. 1, Special Diet Services Limited, Witham, UK), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 40-50
- Air changes (per hr): ~10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
MAXIMUM DOSE VOLUME APPLIED: 6.08 mL/kg
Doses:
5000 mg/kg bw
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: 0.5, 1, 2, 3, 4 and 5 hours following dosing; on subsequent days at least once
- Frequency of weighing: weekly (on day 0, 7, 14)
- Necropsy of survivors performed: yes

Results and discussion

Effect levelsopen allclose all
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Remarks on result:
other: no animal died within the observation period
Sex:
male/female
Dose descriptor:
LD0
Effect level:
5 000 mg/kg bw
Mortality:
- no deaths occurred
Clinical signs:
- shortly after dosing: abnormal body carriage (hunched posture), lethargy, pilo-erection and a decreased respiratory rate
- in some animals: diarrhoea and ptosis
- recovery of all rats complete at day 3 (judged by external appearance and behaviour)
Body weight:
- body weight development was not impaired
Gross pathology:
- in three rats congestion of the lungs only
- no macroscopic abnormalities seen in any of the remaining rats

Any other information on results incl. tables

Read-across justification: for details please see read-across report in IUCLID section 13

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the tested conditions, the substance does not reveal acute oral toxicity.
Executive summary:

The test item (purity: not stated) was administered to 5 male and 5 female Sprague-Dawley albino rats by gavage at the limit dose of 5000 mg/kg bw according to testing guideline OECD 401. Following dosing minor clinical signs (as e.g. hunched posture, pilo-erection as well as diarrhoea or ptosis) occured, but were all reversible within 3 days. During the 14 days observation period no animal died. Subsequent gross pathology revealed congestions of the lungs in three rats, but no other macroscopic changes were seen. The given results lead to a LD0 = 5000 mg test item per kh bw (LD50 > 5000 mg/kg bw; Ruhrchemie AG/Safepharm, 1985).

This study was judged to be reliable with restrictions (RL2), due to the missing substance composition and purity.

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