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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Repeated dose toxicity: oral

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Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Not specified
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study conducted to GLP (taken from SNIF file). Registrant referring to studies >12 years old at the permission of ECHA.

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed
Report date:
1991

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
Deviations:
not specified
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
406-040-9
EC Name:
-
Cas Number:
125643-61-0
Molecular formula:
C17 H25 O3 R, Where R = (C7 H15) or (C8 H17) or (C9 H19)
IUPAC Name:
C7-9-(branched)-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
No data

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: dest. water with 4% sodium carboxymethylcellulose and 0.2% Tween 80
Details on oral exposure:
Method of administration: feeding tube
Analytical verification of doses or concentrations:
not specified
Details on analytical verification of doses or concentrations:
No data
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
0, 5, 50, 250 mg/kg bw/day
Basis:
actual ingested
No. of animals per sex per dose:
Male: 10 animals at 0 mg/kg bw/day
Male: 10 animals at 5 mg/kg bw/day
Male: 10 animals at 50 mg/kg bw/day
Male: 10 animals at 250 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 10 animals at 5 mg/kg bw/day
Female: 10 animals at 50 mg/kg bw/day
Female: 10 animals at 250 mg/kg bw/day
Control animals:
not specified
Details on study design:
No data
Positive control:
No data

Examinations

Observations and examinations performed and frequency:
No data
Sacrifice and pathology:
No data
Other examinations:
No data
Statistics:
No data

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Mortality:
no mortality observed
Body weight and weight changes:
no effects observed
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:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Gross pathological findings:
not specified
Histopathological findings: non-neoplastic:
not specified
Histopathological findings: neoplastic:
not specified
Details on results:
Clinical observations:
No premature deaths occurred. The general condition and the body of the animals were unaffected.

Laboratory findings:
Haematologically and biologically, no treatment-related toxic changes were found.

Effects in organs:
At the end of the trial, a reversible absolute and relative liver weight increased was observed in the animals of the high dose group. Macroscopic assessment determined no assessment-related body changes. Microscopically a centrolobular hypertrophy of hepatocytes, was noted in animals of the high dose group in the liver; this was totally reversible in the observation period. In both sexes of the high and the low and medium dose group hypertrophy was noted in the thyroid gland. These changes were all fully reversible in the course of the recovery period, and are considered to be adaptive, reversible alterations. All further findings corresponded to the spontaneous pathological spectrum of the age range of the species.

Effect levels

Dose descriptor:
NOAEL
Effect level:
5 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Classified as: Not classified. Effects noted where due to adaptations that were fully reversible following cessitation of the study.
Executive summary:

NOAEL 5 mg/kg bw/day (nominal)

Effects noted where due to adaptations that were fully reversible following cessitation of the study. The substance is not classified; this conclusion has been reviewed previously under the 7th Amendment "Notification" Scheme and the conclusion is that the substance is "not classified" for this effect.