Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Test performed prior to the implementation of the current acknowledged testing and GLP guidelines. The test conducted however was in principle very similar to the OECD 401 adopted in 1981. Important aspects (e.g. 14 day-postobservation time) were considered. But short report, limited documentation, non-GLP, females only.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female
Details on test animals and environmental conditions:
TEST ANIMALS
- Strain: Hoe WISKf (SPF 71)
- Source: Hoechst AG, own breeding stock
- Weight at study initiation: 142 - 180g (average 165g)
- Fasting period before study: 16 hours
- Housing: plastic cages
- Diet: Altromin 1324, ad libitum
- Water. tap water, ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: demineralized water
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 25 % suspension (w/v)
Doses:
5.000 mg/kg bw
No. of animals per sex per dose:
10 females
Control animals:
other: not necessary
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of body weighing: 1/week
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, necropsy

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LD0
Effect level:
>= 5 000 mg/kg bw
Remarks on result:
other: no lethality of any of the 10 female rats
Mortality:
none detected
Clinical signs:
none detected
Body weight:
body weight development in postobservation period: normal
Gross pathology:
no macroscopic effects (dissection of killed rats after post-observation period)

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The LD50 was >5.000 mg/kg bw after single oral gavage in female rats.
No classification for acute oral toxicity according to EC 1272/2008.
Executive summary:

Female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage at a dose of 5000 mg/kg bw (25 % suspension in demineralized water). No animal died during the 14 day observation period, resulting in a LD50 >5000 mg/kg bw.