Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Aug 11, 1988 to Aug 25, 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 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
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 flame retardant product.

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals and environmental conditions:
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 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 Rabbit Ration, ad libitum, checked daily and added or replaced as needed. Fresh tap water ad libitum.

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
other: moistened with saline
Details on dermal exposure:
Test substance applied uniformly to shaved skin over an area approximating 10% of the total body surface area.
Duration of exposure:
24 hr
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5M/5F
Control animals:
no
Details on study design:
See Overall Remarks

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
None related to test article administration. One animal had diarrhea.
Body weight:
No change
Gross pathology:
None
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 dermal LD50 was greater than 2000 mg/kg bw.
Executive summary:

In a limit test, the test article was administered dermally to one group of 10 New Zealand White rabbits (5 males and 5 females) at a single dose of 2,000 mg/kg. The test material was held in contact with the skin under a wrapping for 24 hours. The rabbits were observed 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.  The dermal LD50 was greater than 2,000 mg/kg.