Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-10-2/2001-01-12
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2001
Report Date:
2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Identification: Polyamide CAS No. 68990-47-6
Physical Description: Dark solid
Storage: Room temperature
Density. 1.01 g/mL

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Texas Animal Specialties
- Housing: 1 per cage
- Diet : ad libitum
- Water : ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 30-70%
- Air changes (per hr): 10/20
- Photoperiod (hrs dark / hrs light): 12 h cycle

IN-LIFE DATES: From: To:

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
acetone
Doses:
2020 mg/kg
No. of animals per sex per dose:
5 males and 5 females (nulliparous and non pregnant)
Control animals:
yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 020 mg/kg bw
Based on:
test mat.
Mortality:
One female died during the study. The estimated acute oral LD50, as indicated by the data, was determined to be greater than 2020mg/kg.
Clinical signs:
Clinical signs included activity decrease, diarrhea, polyuria, red fluid around anus and soft feces, which were no longer evident in surviving animals by day 1. Gasping, respiratory chirp, and swollen/stained face were observed only in the animal that died on test.
Body weight:
Body weight gain in surviving animals was unaffected by the administration of the test substance.
Gross pathology:
The gross necropsy on the animal that died on test revealed stained/wet/matted fur; tail tip missing; discolored lungs, liver and contents of the stomach and small intestine; gas in the stomach/small intestine and empty large intestine. The gross necropsy on 6 of 9 animals surviving to termination of the study revealed discolored heart and/or lungs; remaining three showed no observable abnormalities.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was evacuate for its acute oral toxicity potential when administered to albino rats. The acute oral LD50, as indicated by the data, is greater than 2020 mg/kg in males and females.