Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
August 3, 1998 to August 17, 1988
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study performed using the commercial SAYTEX 8010 Flame Retardant as the test article and performed according to international guidelines and GLPs.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1988
Reference Type:
publication
Title:
Unnamed
Year:
2007

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
Deviations:
no
GLP compliance:
yes
Test type:
fixed dose procedure
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
The test article was the commercial product.
Specific details on test material used for the study:
White/Off-white powder. Lot SH-6427-49.

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals and environmental conditions:
Young adult rats aquired from Charles River Laboratories, Wilmington, Mass. Acclimated for 5 days prior to use. Individually identified by metal ear tag.

Separate isolation by test system. Light cycle: 12 hr light, 12 hr dark. Temperature/humidity: maintained at 22°C ± 3°C and 30 to 70% humidity. Rats housed individually in stainless steel ½ “ wire mesh cages sized in accordance with “Guide for the Care and Use of Laboratory Animals” of the Institute of Laboratory Resources, National Research Council. Waste material removed twice weekly. Cages and feeder sanitized every 2 weeks. Wayne Lab Blox, ad libitum, checked daily and added or replaced as needed. Fresh tap water ad libitum.

Fasted overnight prior to adminstration of test material.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Details on oral exposure:
See Overall Remarks
Doses:
5000 mg/kg bw as a suspension in 0.25% methylcellulose. Dosing volume 10 ml/kg.
No. of animals per sex per dose:
5M/5F
Control animals:
no
Details on study design:
See Overall remarks.

Results and discussion

Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None
Body weight:
No effect
Gross pathology:
No gross lesions
Other findings:
None

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The oral LD50 in the rat was > 5000 mg/kg, the highest dose tested.
Executive summary:

In a limit test, the test article was administered orally by gavage to one group of 10 Sprague Dawley rats (5 males and 5 females) at a single dose level of 5,000 mg/kg. The rats were observed at one, four and twenty-four hours after dosing and once daily for 14 days. No clinical signs of test article-related toxicity were observed. None of the animals died during the study. No gross lesions were observed at necropsy (animals were sacrificed by CO2 inhalation at the end of the observation period). The oral LD50 was greater than 5,000 mg/kg.