Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study without detailed documentation

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
Deviations:
not applicable
GLP compliance:
no
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Test animals

Species:
rat
Strain:
Wistar
Remarks:
Albino rat
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: no data
- Females (if applicable) nulliparous and non-pregnant: [yes]
- Age at study initiation: no data (adult)
- Weight at study initiation: no data
- Fasting period before study: yes
- Housing: groups of 3
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
single exposure
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
3 males and 3 females
Control animals:
no
Details on study design:
no data

Results and discussion

Effect levels
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
no deaths occurred
Clinical signs:
Piloerection, hunched posture, dyspnoea, diarrhea observed on the day of TS application
Body weight:
no data
Gross pathology:
No clinical findings noted.
Other findings:
Extremities showed blue discolouration. Animals recovered fully within 6 days.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
LD 50 > 2000 mg/kg bw.
Executive summary:

The test substance is judged to harvest no acute orla toxicity to rats.