Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: scientifically acceptable and well documented

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Principles of method if other than guideline:
Three groups of 5 male and 5 female Wister rats (avarage weight 173-177 g) each reveived per gavage 2000, 3100 or 5000 mg/kg bw Vorprodukt Katalysator WAZ 5596 B. The animals were observed for mortality, weight and clinical signs through day 14. A gross pathological examination was performed on animals which died during the observation period or were killed after termination of the study.
GLP compliance:
yes
Test type:
standard acute method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Vorprodukt Katalysator WAZ 5596 B, brown liquid

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
polyethylene glycol
Remarks:
Lutrol
Doses:
2000, 3100 or 5000 mg/kg bw
No. of animals per sex per dose:
5 per sex/dose
Control animals:
not specified

Results and discussion

Effect levelsopen allclose all
Sex:
female
Dose descriptor:
LD50
Effect level:
ca. 2 500 mg/kg bw
Based on:
test mat.
Sex:
male
Dose descriptor:
LD50
Effect level:
>= 3 100 - <= 5 000 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

A single dose of 3100 and 5000 mg/kg bw Vorprodukt Katalysator WAZ 5596 B caused to following signs of intoxication: sedation, cyanosis, disordered breathing and a reduction of general condition rough fur, and bloody eye lids. An increased diuresis was observed on male rats and female rats dosed with 3100 or 2000 mg/kg bw, respectively. Staggered gait and bloody snouts were obvious on males with 3100 and 5000 mg/kg bw and on females with 2000 to 5000 mg/kg bw. Sedation and prone position was seen at one male and several female rats at doses of 5000 mg/kg bw or 3100 and 5000 mg/kg bw, respectively.

Gasping had three female rats. One male and one female each dosed with 5000 mg/kg bw had signs of paralysis on the hind legs. Weight reduction was observed on 3 females dosed with 2000 mg/kg bw and 1 male rats dosed with 3100 mg/kg bw during the first observation week.

Additional, with doses of 200 to 400 µl/kg bw a weight reduction was observed.

Symptoms were evident 1 hour after application and continued until the last day of the examination period. Deads occured after 3 hours until day 3.

Applicant's summary and conclusion

Executive summary:

Three groups of 5 male and 5 female Wister rats (avarage weight 173-177 g) each reveived per gavage 2000, 3100 or 5000 mg/kg bw Vorprodukt Katalysator WAZ 5596 B. The animals were observed for mortality, weight and clinical signs through day 14. A gross pathological examination was performed on animals which died during the observation period or were killed after termination of the study. The approximative LD50 was 3100 to 5000 mg/kg bw for male rats and 2500 mg/kg bw for female rats.