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:
comparable to guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
acute toxic class method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Specific details on test material used for the study:
Source of report or test material: UniroyalChemical Company Middlebury, CT
Label: Polylite
Description: Dark brown liquid
The test article was stored in the container provided by the sponsor at ambient room temperature and humidity
Specific gravity: 0.93

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Ace Animals
- Females (if applicable) nulliparous and non-pregnant: no data
- Age at study initiation: No data
- Weight at study initiation: 284-297g for males and 235-255 g for females.
- Fasting period before study: 16-24h
- Housing: 5 per cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days

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

IN-LIFE DATES: From: Aug 7, 1981 To: Aug 21, 1981

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
The rats were observed twice daily for 14 days for mortality and toxicity. Body weights were recorded pretest, weekly and at death. All rats were examined for gross pathology.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no mortality observed
Mortality:
None
Clinical signs:
Anogenital area stained brown (two females during two days)
Chrornodacryorrhea (each one male and one female during one day)
Dyspnea (one male during two days)
Ptosis (one female during one day)
Chromorhinorrhea (one male during one day)
Body weight:
No changes
Gross pathology:
One animal had parts of the intestine with a yellow coloration.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
No mortality was observed at a single dose of 5000 mg/kg bw.