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:
2003
Report Date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
other: CD / Crl: CD
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: males approx. 6 weeks, females approx. 7 weeks
- Weight at study initiation: males 197-205 g, females 179-196 g
- Fasting period before study: approx. 16 hours before administration
- Housing: 2-3 animals/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C +/- 3°C
- Humidity (%): 55% +/- 15%
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 17.03.2003 To: 10.04.2003

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
other: aqueous hydroxypropylmethylcellulose
Details on oral exposure:
The test substance was suspended in 0.8% aqueous hydroxypropylmethylcellulose gel to obtain a concentration of 200 mg Benzalhydantoin/mL. The administration volume was 10 mL/kg b.w. in order to obtain a dose of 2000 mg Benzalhydantoin/kg b.w.
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: before and immediately after administration; at 5, 15, 20 and 60 min, as well as at 3, 6 and 24 hours after administration and once a day for a period of 14 days
- Observations on mortality were made at least once daily to minimize loss of animals during the study. The time of death was recorded as precisely as possible.
- Frequency of weighing: day 0 (prior to dosing), day 7 and day 14
- Necropsy of survivors performed: yes
- Other examinations performed: gross examination of organs at necropsy

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No mortality occurred throughout this study.
Clinical signs:
Slightly reduced motility, slight ataxia and slight dyspnoea.
Body weight:
No effects on body weight and body weight gain.
Gross pathology:
No macroscopical findings were noted at autopsy.
Other findings:
The LD50 could not be determined as no mortality occurred.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
In this acute oral toxicity study in the rat the LD50 was determined to be determined >2000 mg/kg bw.