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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: OECD Guideline and GLP compliant study

Data source

Reference
Reference Type:
other: Inquiry result from ECHA
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Directive 84/449/EEC, Method B7
GLP compliance:
yes
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc
EC Number:
403-360-0
EC Name:
Bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc
Cas Number:
42405-40-3
Molecular formula:
C30H42O6Zn
IUPAC Name:
bis(3,5-bis(1,1-dimethylethyl)-2-hydroxybenzoato-O1,O2)zinc

Test animals

Species:
other: rat, Wistar albino

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: no vehicle used
Details on oral exposure:
Method of administration:
Diet administration
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 16.1 mg/kg bw/day
Male: 5 animals at 80.4 mg/kg bw/day
Male: 5 animals at 433 mg/kg bw/day

Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 16.9 mg/kg bw/day
Female: 5 animals at 81.7 mg/kg bw/day
Female: 5 animals at 375 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
Emaciation and rough, dirty coats were observed in group 4: growth , food intake and food efficiency decreased. No other findings.

Laboratory findings:
Haematology:

Group 4: slight increase in red blood cells, haemoglobulin concentration and packed cell volume. Slightly lower total thrombocyte counts.

Clinical biochemistry:
Group 4: Increase in alkaline phosphatase, GOT and GPY activities and in total bilirubin, urea and chloride levels.
Also a decrease in fasting blood glucose level was noted.

Urinalysis:
Group 4 females: a slight dose-related increase in urine production, related to a decrease in urine density.

Effects in organs:
Group 4: decrease in absolute liver weights (male and female) and in several other organs (females only). Relative weights of testes and adrenals were increased (males only)

The relative weight of the liver was slightly increased in males of Group 3 and decreased in females in Group 4.

Pathology:
Group 4: 9/10 animals showed less pronounced lobular pattern compared to the control animals, due to hypertrophy of the centrilobular hepatocytes.

All other findings were commonly seen in the strain of rats used.

Effect levels

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Dose descriptor:
NOAEL
Effect level:
ca. 80 mg/kg bw/day (nominal)
Basis for effect level:
other: original NCD unit is mg/kg/day
Dose descriptor:
NOEL
Effect level:
ca. 80 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