Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: Bor: WISW (SPFCpb)
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co. KG, Borchen, Germany
- Age at study initiation: males 7-8 weeks, females 9-10 weeks
- Weight at study initiation: males 140-199 g, females 148-168 g
- Fasting period before study: 16 hours before treatment
- Housing: 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5-22.5°C
- Humidity (%): 40-65%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 18.04.1989 To: 04.05.1989

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
peanut oil
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 100, 147 and 215 mg/mL
- Amount of vehicle (if gavage): 2.15 mL/kg bw
- Justification for choice of vehicle: test item practically insoluble in water
Doses:
215, 316 and 464 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: continuously for the first 4-6 hours after adminstration, thereafter once daily
- Frequency of weighing: day 0, 7 and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross necropsy
Statistics:
females: probit analysis
males: graphic estimation

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
313 mg/kg bw
95% CL:
221 - 443
Remarks on result:
other: probit analysis
Sex:
male
Dose descriptor:
LD50
Effect level:
381 mg/kg bw
Remarks on result:
other: graphic estimation
Mortality:
Males: 0/5, 0/5, 5/5
Females: 0/5, 3/5, 5/5
Deaths occured 40 minutes to 4 hours after administration.
Clinical signs:
The most dominant signs of toxicity were clonic convulsions, mydriasis and piloerection. Hypokinesia, stilted gait, strenous respiration, reddened skin, cyanosis, sunken sides and vocalization were recorded, too. Additionally chromodacryorrhea, red nasal discharge and salivation was observed in some rats. Ante mortem dyspnea and general loss of reflexes were noticed.
In general symptoms were observed 5-370 minutes after treatment. The symptoms lasted for some hours, some days or until death.
Body weight:
No effect
Gross pathology:
Only deceased rats showed reddening and spotted red to dark red discoloration in the glandular stomach and the small intestine.

Applicant's summary and conclusion

Interpretation of results:
Category 4 based on GHS criteria
Remarks:
Migrated information
Conclusions:
In this acute oral toxicity study in the rat the test item showed an LD50 value of 313 mg/kg bw for females and 381 mg/kg bw for males. The test item is corrosive and findings are considered to be mainly due to corrosivity.