Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1.4. - 15.4.1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study with acceptable restrictions. Study was performed before GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: WIGA, Sulzfeld, Germany
- Weight at study initiation: 235 - 279 g (males), 187 - 212 g (females)
- Fasting period before study: Animals were fasted about 18 h prior to administration.
- Housing: Animals were housed in groups of five in Wire IV cages.
- Diet: SFI Rats and Mice standard feed (pellets), ad libitum
- Water: tap water, ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21.0 - 24.5
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES:
From: 01.04.1981
To: 15.04.1981

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: as 20% emulsion in a 2% aqueous Tween 80 solution
Details on oral exposure:
VEHICLE
- Concentration in vehicle: 10 and 20% (w/v)

MAXIMUM DOSE VOLUME APPLIED: 20 mL/kg bw
Doses:
2000 and 4000 mg/kg bw
No. of animals per sex per dose:
10
Control animals:
other: not required
Details on study design:
- Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Animals were observed continiously until 5 h after dosing and then at least twice daily over a period of two weeks. Body weights were recorded prior to application and on Days 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred during the study period.
Clinical signs:
Clinical signs observed were apathia (3/10 males, 2/10 females), stupor (3/10 males, 2/10 females), comatose state (1/10 males), ataxia (2/10 males), flaccid paresis (1/10 males), lateral position (1/10 males), chromodacryorrhoea (2/10 males), ptosis (1/10 males), blood crusted nose (2/10 males), perianal-coat brownish soiled (2/10 males), bradypnoea (1/10 males), impeded breathing (3/10 males, 2/10 females), descent of the testis (10/10 males).
Body weight:
No influence of the test substance treatment on body weight and body weight gain was noticed.
Gross pathology:
In 5 animals, hyperplasia of Peyer's patches was observed in 1/5 males and 3/5 females at 2000 mg/kg bw and in 1/5 males at 4000 mg/kg bw.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
CLP: not classified
DSD: not classified