Registration Dossier

Toxicological information

Repeated dose toxicity: oral

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This report is of limited use because the white oil was used as a control and the responses to it were not compared to an untreated control. Nevertheless it provides supportive information of the lack of effects in a gavage study of 13 week duration.

Data source

Reference
Reference Type:
publication
Title:
Assessment of the potential reproductive and subchronic toxicity of EDS coal liquids in Sprague-Dawley rats
Author:
McKee, R.H., Plutnick, R.T., Traul, K.A.
Year:
1987
Bibliographic source:
Toxicology 46:267-280

Materials and methods

Principles of method if other than guideline:
No guideline was explicitly stated, but the protocol appears to follow OECD Guideline 408 (Repeated Dose 90-day Oral Toxicity in Rodents) with deviations. The white oil was used as a control and the responses to it were not compared to an untreated control.
GLP compliance:
not specified
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
IUCLID4 Test substance: other TS: White oil

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
unchanged (no vehicle)
Details on oral exposure:
Only the information on controls will be summarized here since the experimental samples were not white oils, and therefore, not relevant to this summary. The control group comprised 90 females and 36 males and the white oil was administered orally by gavage at a dose of 5 ml/kg five times weekly for 13 weeks.
Duration of treatment / exposure:
90 days
Frequency of treatment:
5 days/week
Doses / concentrations
Remarks:
Doses / Concentrations:
5 ml/kg/day
Basis:

No. of animals per sex per dose:
90 females, 36 males
Control animals:
no

Examinations

Observations and examinations performed and frequency:
At the end of 13 weeks dosing 18 females were removed from the study for an evaluation of repeat dose toxicity. The males were then used for mating and after mating were evaluated for repeat dose toxicity. Fourteen days after cessation of administration of white oil, blood samples were collected; the animals were sacrificed and necropsied. A wide range of haematological and clinical chemical measurements were made, major organs were weighed and a wide range of tissues were examined histologically.

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):
not specified
Food efficiency:
not specified
Water consumption and compound intake (if drinking water study):
not specified
Ophthalmological findings:
not specified
Haematological findings:
no effects observed
Clinical biochemistry findings:
no effects observed
Urinalysis findings:
not specified
Behaviour (functional findings):
not specified
Organ weight findings including organ / body weight ratios:
no effects observed
Gross pathological findings:
no effects observed
Histopathological findings: non-neoplastic:
no effects observed
Histopathological findings: neoplastic:
not specified

Effect levels

Dose descriptor:
NOAEL
Effect level:
>= 5 other: mL/kg bw/day
Sex:
male/female
Basis for effect level:
other: lack of effects

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Although effects were noted in those groups of animals exposed to the test materials, the report made no comment that the control values (i.e.  those for white oil exposed animals) were outside of the normal range for  control animals.  Furthermore no adverse histological observations were  made for those animals exposed to the white oil.

Applicant's summary and conclusion

Conclusions:
This report is of limited use because the white oil was used as a control and the responses to it were not compared to an untreated control. Nevertheless it provides supportive information of the lack of effects in a gavage study of 13 week duration. No effects were seen in male or female rats dosed with white oil at 5 mL/kg bw/day for 90 days. The NOAEL is therefore >= 5 mL/kg bw/day.
Executive summary:

White oil was used as vehicle and also as control substance in a combined  90 -day repeat dose and reproductive toxicity study of EDS coal liquids.   Only the information on controls will be summarized here since the  experimental samples were not white oils, and therefore, not relevant to this summary.

 

The control group comprised 90 females and 36 males and the white oil was  administered orally by gavage at a dose of 5 ml/kg five times weekly for 13 weeks. At the end of 13 weeks dosing 18 females were removed from the study for  an evaluation of repeat dose toxicity. The males were then used for mating and after mating were evaluated for repeat dose toxicity. Fourteen days after cessation of  administration of white oil, blood samples were collected; the animals  were sacrificed and necropsied.  A wide range of haematological and  clinical chemical measurements were made, major organs were weighed and a  wide range of tissues were examined histologically.

 

Although effects were noted in those groups of animals exposed to the test materials, the report made no comment that the control values (i.e.  those for white oil exposed animals) were outside of the normal range for  control animals.  Furthermore no adverse histological observations were  made for those animals exposed to the white oil.

 

This study was given a Klimisch score of 4 and classified as not assignable because this report is of limited use. The white oil was used as a control and the responses to it were not compared to an untreated control. Nevertheless it provides supportive information of the lack of effects in a gavage study of 13 week duration.