Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
other: secondary literature
Adequacy of study:
supporting study
Study period:
no data
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insuficient for assessment (abstract with minimum details)

Data source

Reference
Reference Type:
other: Letter to EPA under TSCA 8e procedure
Title:
Unnamed
Year:
1997

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
no data
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Reference substance name:
bis(hydrogentade tallow alkyl) methylamine
IUPAC Name:
bis(hydrogentade tallow alkyl) methylamine
Constituent 2
Reference substance name:
Amines, bis(hydrogenated tallow alkyl)methyl
EC Number:
262-991-8
EC Name:
Amines, bis(hydrogenated tallow alkyl)methyl
Cas Number:
61788-63-4
IUPAC Name:
61788-63-4
Details on test material:
no data available

Test animals

Species:
rat
Strain:
Fischer 344
Sex:
male/female
Details on test animals or test system and environmental conditions:
no data available

Administration / exposure

Route of administration:
oral: feed
Details on oral exposure:
no data available
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
13 weeks
Frequency of treatment:
daily
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
0, 1.1, 5.3, 28.8 and 261.9 mg/kg/d (male)
Basis:
actual ingested
Remarks:
Doses / Concentrations:
0, 1.1, 5.4, 27.1 and 264 mg/kg/d (female)
Basis:
actual ingested
No. of animals per sex per dose:
10
Details on study design:
no data available

Examinations

Observations and examinations performed and frequency:
no data available
Sacrifice and pathology:
no data available
Statistics:
no data available

Results and discussion

Results of examinations

Clinical signs:
not specified
Mortality:
not specified
Body weight and weight changes:
effects observed, treatment-related
Food consumption and compound intake (if feeding study):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
not specified
Clinical biochemistry findings:
not specified
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Gross pathological findings:
effects observed, treatment-related
Histopathological findings: non-neoplastic:
effects observed, treatment-related
Histopathological findings: neoplastic:
not specified
Details on results:
- Organ weight effects were observed at the highest dose level of 250mg/kg/day wherein lower terminal BW were accompanied by a corresponding secondary increase in the relative organ/body weight ratio for adrenal, kidney, liver and testes.
- At the highest dose level, the principal response was an infiltrate of inflammatory cells within the jejunum of the small intestine, mesenteric lymph node, spleen, mediastinal lymph node, interstitium of the ovary and possibly the liver. At the next lower dose level, target tissues were limited to the jejunum and the mesenteric lymph nodes.

No other data available.

Effect levels

Dose descriptor:
NOEL
Effect level:
1.1 mg/kg bw/day (nominal)
Sex:
male/female

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Documentation insufficient to perform a scientific assessment of the study.