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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:
supporting study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
The study has been performed according to OECD and EC guidelines and according to GLP principles. The data relating to the identity, purity and stability of the test material are not mentioned in the test report but can be retrieved from the original NONS notification.

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: Annex V
Qualifier:
according to
Guideline:
OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
Deviations:
no
GLP compliance:
yes
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): CETEC 2254
- Physical state: straw coloured liquid
- Analytical purity: not indicated

Test animals

Species:
other: Rat (Sprague-Dawley)

Administration / exposure

Route of administration:
oral: unspecified
Vehicle:
other: Substance tested as supplied.
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: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 500 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 150 mg/kg bw/day
Female: 5 animals at 500 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day

Results and discussion

Results of examinations

Details on results:
Clinical observations:
There were treatment-related clinical signs of toxicity
observed.

Laboratory findings:
Haematology/Blood Chemistry No treatment-related changes in
the haematological parameters measured. There were no
treatment-related changes detected in the blood chemical
parameters measured.

Effects in organs:
There were no treatment-related changes detected in the
organ weights measured. Males treated with 500 mg/kg/day
showed a statistically significant reduction in absolute
epididymides weight when compared with controls but, in the
absence of a convincing dose-response relationship, this
finding was considered to be incidental and of no
toxicological significance.


There were no treatment-related macroscopic abnormalities
detected at terminal kill.


Treatment-related kidney changes were observed. Three males
treated with 1000 mg/kg/day demonstrated globular
accumulations of eosinophilic material in the proximal
tubular epithelium which should be regarded as a possible
effect of treatment. This finding is consistent with the
appearance of hydrocarbon nephropathy and is not considered
to represent a hazard to human health.


No such effect was observed among 500 or 150 mg/kg/day
animals.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Sex:
male/female
Basis for effect level:
other: original NCD unit is mg/kg/day.
Dose descriptor:
NOEL
Effect level:
500 mg/kg bw/day (nominal)
Sex:
male
Basis for effect level:
other: original NCD unit is mg/kg/day.

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

Comments:
The kidney changes identified histopathologically were
consistent with well documented changes that occur in the
male rat in response to treatment with some hydrocarbons.
This effect is not indicative of a hazard to human health.

Applicant's summary and conclusion

Conclusions:
Classified as: Not classified