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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP compliance, not OECD guideline

Data source

Reference
Reference Type:
other: not applicable as the submitted data has passed exceeded 12 protecting years
Title:
Unnamed
Year:
2014

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Annex V
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
400-820-2
EC Name:
-
Cas Number:
84268-33-7
Molecular formula:
C20H23N3O3
IUPAC Name:
methyl 3-[3-(2H-1,2,3-benzotriazol-2-yl)-5-tert-butyl-4-hydroxyphenyl]propanoate

Test animals

Species:
rat

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: 0.5% Carboxymethyl cellulose with 0.1% Tween 80 (test material in suspension)
Details on oral exposure:
Method of administration:
Gavage
Duration of treatment / exposure:
Test duration: 28 days
Frequency of treatment:
Dosing regime: 7 days/week
No. of animals per sex per dose:
Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 mg/kg bw/day
Male: 5 animals at 200 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 200 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
No deaths. Marked reduction in body weight gain of males at
1000 mg/kg.
Laboratory findings:
Increased activity of plasma ALT and AST at 1000 mg/kg (both
sexes) and AST at 200 mg/kg (females). Plasma levels of urea
and bilirubin were increased, and total globulins
decreased, in males at 1000 mg/kg.
Effects in organs:
Increased relative liver weight, recent hepatic necrosis
(extensive with haemorrhages in one high dose male, focal in
one male at 200 mg/kg and two males at 50 mg/kg) and
hepatocyte hypertrophy (most rats) were noted at 50 mg/kg
and above; one male at 50 mg/kg had a liver nodule. Relative
kidney weight was clearly increased at 1000 mg/kg and an
apparent dose related trend was evident but no treatmentrelated
lesions were seen.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
< 50 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
< 50 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