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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
other: Body responsible for the test
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
Reference substance name:
A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates
EC Number:
407-000-3
EC Name:
A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates
Cas Number:
127519-17-9
IUPAC Name:
A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates

Test animals

Species:
other: Rat (Tif:RAI)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: Distilled water containing 0.5% ‘ CMC' and 0.1 % Tween 80
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: 20 animals at 0 mg/kg bw/day
Male: 20 animals at 2 mg/kg bw/day
Male: 20 animals at 50 mg/kg bw/day
Male: 20 animals at 500 mg/kg bw/day
Female: 20 animals at 0 mg/kg bw/day
Female: 20 animals at 2 mg/kg bw/day
Female: 20 animals at 50 mg/kg bw/day
Female: 20 animals at 500 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:

There were no deaths. Mean body weight was depressed at 500
mg/kg from week 2 for males and in week 4 for females. Food
consumption was similarly depressed. Recovery animals showed
recovery from these effects (Through weeks 5-8).

Laboratory findings:
Mild anaemia, associated with higher reticulocyte counts,
was observed in males at 500 mg/kg. Slightly lower vales for
RBC, HGB, and HCT were observed in males at 50 mg/kg, and in
females at 500 mg/kg.

Slight Hyperglycaemia occurred in both sexes at 500 mg/kg
and 50 mg/kg. Other slight changes included elevated plasma
cholesterol and TGC in females at 500 mg/kg, and decreased
plasma protein in males of the same group. Increased ALP for
both sexes at 500 mg/kg and in males only at 50 mg/kg. ASAT
was increased in males and 2 females at 500 mg/kg.


Effects in organs:
Liver weight was increased in males in all dosed groups,
dose-related, and in females at 500 mg/kg Hepatocyte
hypetrophy was seen in both sexes a! 500 mg/kg and 50
mg/kg. Hepatocyte e necrosis occurred at low incidence in
occasional animals, apparently dose related.

Minimal hypertrophy of the thyroid follicular epithelium
occurred in 2 males in each group a! 500 mg/kg and 50 mg/kg
and in 1 female at 50 mg/kg.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
2 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
2 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