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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

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2000-01-14 to 2000-05-10
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2000
Report date:
2000

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
GLP compliance:
yes (incl. QA statement)
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Ethyl 6,8-dichlorooctanoate
EC Number:
435-080-1
EC Name:
Ethyl 6,8-dichlorooctanoate
Cas Number:
1070-64-0
Molecular formula:
C10H18Cl2O2
IUPAC Name:
ethyl 6,8-dichlorooctanoate
Test material form:
liquid
Specific details on test material used for the study:
Batch: Ds 1099

Test animals

Species:
rat
Strain:
Fischer 344
Remarks:
"CDF (F344)/CRLBR, SPF." as cited in Report
Sex:
male/female
Details on test animals or test system and environmental conditions:
Room temperature Average 20.7°; humidity average 49.2%

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
CMC (carboxymethyl cellulose)
Remarks:
0.5% Solution in Water
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
28 days
Frequency of treatment:
once a day
Doses / concentrationsopen allclose all
Dose / conc.:
0 mg/kg bw/day (nominal)
Dose / conc.:
60 mg/kg bw/day (nominal)
Dose / conc.:
190 mg/kg bw/day (nominal)
Dose / conc.:
600 mg/kg bw/day (nominal)
Dose / conc.:
600 mg/kg bw/day (nominal)
Remarks:
recovery group
No. of animals per sex per dose:
5 male and 5 female
Control animals:
yes, concurrent vehicle
Positive control:
no

Examinations

Observations and examinations performed and frequency:
Body weight; chromodqakryorrhoea, diarrhoea, salivation, behaviour, feed consumption

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):
effects observed, non-treatment-related
Description (incidence and severity):
Feed consumption of high dose recovery males and female was significantly hgher in teh last week of the dosing period (Day 21 through 28) compared to the controls this significance is not given toxicological importance.
Haematological findings:
effects observed, treatment-related
Description (incidence and severity):
eosinophil granulocytes females higher in Low dose
cholesterol males lower in mid dose and high dose
cholesterol females lower in mid dose and high dose
alkaline phosphatase females higher in mid dose
ALT females higher in mid dose and high dose
AST females higher in mid dose and high dose
BUN females higher in mid dose and high dose
Na+ females lower in high dose
Behaviour (functional findings):
no effects observed
Organ weight findings including organ / body weight ratios:
effects observed, treatment-related
Description (incidence and severity):
liver weight males higher in mid dose and hgh dose
liver weight females higher in mid dose and hgh dose
adrenals weight males higher in high dose after recovery
heart weight males lower in mid dose

Effect levels

Key result
Dose descriptor:
NOAEL
Effect level:
60 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
organ weights and organ / body weight ratios

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Based on the results of the study, the NOAEL is 60 mg 6,8 Dichloroethylcaprylate per kg body weight and day in rats of both sexes
Executive summary:

Effects of the test substance were noted in the high and the mid dosed amimals of both sexes at observations in life, and clinical chemistry, organ weight determination and at histopathological examination.

Two major effects of the test substance were thereby elucidated:

Firstly, the test substance caused salivation for a short time after administration. This could be due to a vagotonic effect or to an extremely poor palatability, as minimal amounts to the test may be deposited in the oral cavity even at a careful gavage.

Secondly, the test substance is hepatotoxic. Findings at clinical chemistray, organ weight determiantion and histopathology together indicate the presence of a mild hepatocellular degeneration.

Some other significant differences or abnormal findigs are considered to be incidental significances (e. g. in the feed consumption, heart weight changes etc.) or secondary changes (adrenal weight increase due to chronic stress).

The changes noted did not become life threatening.

The hepatic changes partly persisted until the end of the recovery period, but were clearly reduced in severity.

There was no marked sex differende in the dose response.

Toxic effects were present in the mid and the high dosed group of both exes, none were observed in the low dosed group.

Based on the results of the study, the NOAEL is 60 mg 6,8 Dichloroethylcaprylate per kg body weight and day in rats of both sexes