2-dodec-1-enylbutanedioic acid, 4-methyl ester zinc salt

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

other: Body responsible for the test

Title:

Unnamed

Year:

2005

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))

Deviations:

not specified

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

RZ 97

IUPAC Name:

RZ 97

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain: Crl:CD (SD)BR

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

castor oil

Details on oral exposure:

Method of administration:
by 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 250 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
250 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Clinical signs:

effects observed, treatment-related

Mortality:

mortality observed, treatment-related

Body weight and weight changes:

effects observed, treatment-related

Clinical biochemistry findings:

effects observed, treatment-related

Description (incidence and severity):

at 1000 mk/kg/day group

Gross pathological findings:

effects observed, treatment-related

Description (incidence and severity):

at 1000 mk/kg/day group

Details on results:

Clinicalobservations:
No deaths occurred at any dose.
At the dose of 50 mg/kg/day, none of the examinations performed revealed any change attributable to treatment.
At the dose of 250 mg/kg/day, slight depression in body weight was observed in both sexes.
At the dose of 1000 mg/kg/day, transient salivation was the only clinical change observed in both sexes starting within 15 minutes of the test
article administration. Body weight appeared slightly affected (retarted growth).

Laboratoryfindings:
At the hematological examination and blood chemistry tests no treatment-related variations were found. At the urinalysis the only change noted was an increases in frequency of positive findings of urinal bililrubin in the males of the 1000 mk/kg/day group

Effects in organs:
Post-mortem examinations showed that the test product induced slight changes only in the stomach (degenerative foci of the gastric non glandular mucosa) indicative of slilght irritative properties of the test article on the stomach when administered at the dose of 1000 mg/kg/day.

Effect levels

1

Dose descriptor:

NOAEL

Effect level:

ca. 1 000 mg/kg bw/day (nominal)

Based on:

test mat.

Basis for effect level:

other: original NCD unit is mg/kg/day.

2

Dose descriptor:

NOEL

Effect level:

ca. 50 mg/kg bw/day (nominal)

Based on:

test mat.

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