Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
migrated information: read-across based on grouping of substances (category approach)
Adequacy of study:
key study
Study period:
26 February 1969 to 25 March 1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Guideline study conducted before the adoption of GLP. Read-across of data from a category member. Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, and because available data indicates that parent molecules are not reactive toward biological molecules and cannot undergo bioactivation by normal enzymatic processes, they can be considered to constitute a chemical category. Data gaps for partitioning properties, mammalian and ecological toxicity can therefore be addressed by read-across and/or trend analysis between category members.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1969

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: internal protocol
Principles of method if other than guideline:
2 male and 2 female rats were exposed by intraperitoneal injection to the test article and observed daily for 14 days for clinical signs of toxicity. After the two week observation period the animals were sacrificed and gross necropsy performed.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): FC-40
- Physical state: Liquid

Test animals

Species:
rat
Strain:
other: Charles River
Sex:
male/female
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: "Young"
- Weight at study initiation: 150 g to 200 g
- Acclimation period: 5 days

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
unchanged (no vehicle)
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were weighed at day 1 and 14 of observation. They were observed daily in individual cages.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, histopathology

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 34.6 other: g/kg
Remarks on result:
other: Only one dose was tested. Taking into account the MW of PMM the calculated LD50 is > 15.42 g/kg.
Mortality:
No deaths were observed.
Clinical signs:
Abnormal stance, hypoactivity, muscular weakness and ruffed fur were observed following dose administration. All reactions had ended after 50 minutes with the exception of ruffed fur which subsided after 2 days.
Body weight:
Weight gains were normal.
Gross pathology:
Necropsy revealed clear fluid in the abdominal cavity of all animals; and white soft ovoid masses attached to the mesentery near the blood vessels and or free floating in the cavity. Watery vacuoles were also found in the subcutaneous tissue of the ventral abdomen.

Any other information on results incl. tables

FC-3284 is a member of the Perfluorinated Organic Chemicals, C5-C18, category. All of these chemicals stem from the same manufacturing process, have similar physicochemical properties including high vapor pressure and low water solubility relative to the hydrocarbon analogs (e.g., hexanes v. perfluorohexanes), and also lack any chemically reactive groups, which forms the technical basis for the category. Members of this category are fully fluorinated, meaning that fluorine, rather than hydrogen, is bonded to all carbon atoms in the molecule. Fluorine is the most electronegative of the elements (fluorine has an electronegativity of 3.98 on the Pauling scale, as compared to 2.55 for carbon or 2.20 for hydrogen). This electronegativity is expected to dominate over all other aspects of substance chemistry and is the underlying basis for similarity of substances in this category. Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, and because available data indicates that parent molecules are not reactive toward biological molecules and cannot undergo bioactivation by normal enzymatic processes, they can be considered to constitute a chemical category. Data gaps for partitioning properties, mammalian and ecological toxicity can therefore be addressed by read-across from FC-40.

Applicant's summary and conclusion

Conclusions:
The acute intraperitoneal toxicity results for FC-40 (PTBA, CAS# 1064698-37-8) are reported for read-across to FC-3284 (PMM, CAS# 382-28-5). The acute intraperitoneal median lethal dose (LD50) was found to be greater than 34.6 g/kg for the test article.
Executive summary:

The acute intraperitoneal toxicity results for FC-40 (PTBA, CAS# 1064698-37-8) are reported for read-across to FC-3284 (PMM, CAS# 382-28-5). Undiluted test article was administered by injection into the peritoneal cavity to three groups consisting of four albino rats (2 male, 2 female) each. The dose groups were 15.4, 23.1, and 34.6 grams per kilogram body weight. The rats were observed for pharmacotoxic signs, weight gains and mortality. Results show that the test article elicited abnormal stance, hypoactivity, and muscular weakness at all doses within 2 hours of compound administration. Ruffled fur was also observed at the high dose level. There were no deaths in the study. Weight gains were normal. No lesions were observed at necropsy. The test article can be considered practically non-toxic by intraperitoneal injection. By read-across, the target substance is also considered to be practically non-toxic by intraperitoneal injection.

Study conducted prior to the adoption of GLP. Because these substances exhibit similarity in their physicochemical properties and toxicological properties in mammals, and because available data indicates that parent molecules are not reactive toward biological molecules and cannot undergo bioactivation by normal enzymatic processes, they can be considered to constitute a chemical category. Data gaps for partitioning properties, mammalian and ecological toxicity can therefore be addressed by read across and/or trend analysis between category members. The readacross is considered reliable with restrictions and the result is suitable for use in Risk Assessment, Classification & Labelling, and PBT Analysis.