Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1985
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline Study under GLP analytical purity not indicated, unclear if dosing refers to product tested or active ingredient.

Data source

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

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS- Source: Hoe: WISKf(SPF71), Hoechst AG, Germany- Age at study initiation: males: ca. 6-7weeksfemales: ca 8 weeks- Weight at study initiation:males: mean = 169 g, SD = 6.41, xmin = 160, xmax = 178, n=10females: mean = 181.5 g, SD = 11.7, xmin = 160, xmax = 199, n=10Randomization: yesAnimal maintenance: in fully air-conditioned rooms in macrolon cages (type 4) on soft wood granulate in groups of 5 animalsRoom temperature: 22 ± 3 °CRelative humidity: 50 ± 20 %Lighting time: 12 hours dailyAcclimatization: at least 5 daysFood:Rattendiat Altromin 1324, (Altromin-GmbH, Lage/Lippe), ad libitumWithdrawal of food: from about 16 hours before to 3 - 4 hours after treatmentWater: tap water in plastic bottles, ad libitumAnimal identification: fur marking with KMnO4 and cage numbering

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
water
Remarks:
deionized
Details on oral exposure:
VEHICLE- Concentration in vehicle: 5 % (500mg/kg bw) 25% (2000 mg/kg bw)- Amount of vehicle (if gavage):MAXIMUM DOSE VOLUME APPLIED: 10 ml (25% solution) = 2000 mg/kg bw
Doses:
500, 1000 mg/kg body weight
No. of animals per sex per dose:
10 (5 males, 5 females)
Control animals:
no
Details on study design:
- Duration of observation period following administration: up to 21 days- Frequency of observations and weighing: daily- Necropsy of survivors performed: yes
Statistics:
no

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
500 - 2 000 mg/kg bw
Based on:
test mat.
Mortality:
2000 mg/kg body weight: 100 % mortality500 mg/kg body weight: 0 % mortality
Clinical signs:
Clinical symptoms:- 2000 mg/kg group: flanks drawn-in, decreased spontantenous activity, respiratory sounds, indications of cyanosis, clonic convulsions- 500 mg/kg group: flanks drawn-in, decreased spontaneous activity, squatting posture, salivation (from day 2 p.a. free of symptoms)
Body weight:
Body weight development generally not influenced
Gross pathology:
The macroscopic examination of deceased male and female animals revealed the following features: - Small intestine filled with clear liquid - Small intestinal mucosa reddened - Pancreas reddened - Adrenal dark discolored - Liver dark discolored - Foam in the lung The animals killed at the end of follow-up period were free of macroscopically visible alterations.

Applicant's summary and conclusion

Interpretation of results:
harmful
Remarks:
Migrated informationCriteria used for interpretation of results: EU
Conclusions:
The LD 50 is between 500 and 2000 mg/kg bw.
Executive summary:

The acute oral toxicity of the test item was investigated in groups of 5 male and 5 female Wistar rats each at dose levels of 500 and 2000 mg/kg body weight according to OECD TG 401. The animals rceived the compound in water as vehicle via gavage. The observation period following treatment in the 500 mg/kg group was up to 21 days. Most animals treated at 2000 mg/kg died within 10 minutes after application. One female and one male died 2 and 3 hours p.a. respectively. No mortality occurred in the 500 mg/kg group.Clinical symptoms included hypoactivity, squatting posture and salivation. In the 2000 mg/kg group additionally indications of cyanosis and clonic convulsions were observed shortly before the animals died. Macroscopically a discolouration of the liver, reddenings of the pancreas and the intestinal mucosa, as well as foam in the lungs. Based on the study results, the median lethal dose (LD50) was between 500 and 2000 mg/kg body weight.