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Diss Factsheets

Administrative data

Endpoint:
short-term repeated dose toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2006
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: according to EC Directive 92/69/EEC and Regulation EC/440/2008 guideline methods under GLP conditions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2006
Report date:
2006

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

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
473-730-4
EC Name:
-
Cas Number:
928768-73-4
Molecular formula:
C13H28SO3
IUPAC Name:
1-Octanol reaction products with epichlorhydrin and 2-mercaptoethanol
Test material form:
liquid: viscous
Details on test material:
Batch # 20074-10142005

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Details on test animals or test system and environmental conditions:
The animals were housed in groups of five by sex in polypropylene grid-floor cages suspended over trays lined with absorbent paper. The animals were allowed free access to food and water. A pelleted diet (Rodent 5LF2 (Certified) Diet, BCM IPS Limited, London, UK) was used.
Certificates of analysis of the batches of diet used are given in Appendix 18. Mains drinking water was supplied from polycarbonate bottles attached to the cage. The diet and drinking water were considered not to contain any contaminant at a level that might have affected the purpose or integrity of the study. Environmental enrichment was provided in the form of wooden chew blocks (B & K Universal Ltd., Hull, UK) and cardboard fun tunnels (Datesand Ltd., Cheshire, UK).
The animals were housed in a single air-conditioned room within the Safepharm Barrier Maintained Rodent Facility. The rate of air exchange was at least fifteen air changes per hour and the low intensity fluorescent lighting was controlled to give twelve hours continuous light and twelve hours darkness. Environmental conditions were continuously monitored by a computerised system, and print-outs of hourly mean temperatures and humidities were included in the study records.
The animals were randomly allocated to treatment groups using a total randomisation procedure and the group mean bodyweights were determined to ensure similarity between the treatment groups. The cage distribution within the holding rack was also randomised. The animals were uniquely identified within the study by an ear punching system routinely used in these laboratories.

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
arachis oil
Details on oral exposure:
28 days
Duration of treatment / exposure:
28 days
Frequency of treatment:
daily
Doses / concentrationsopen allclose all
Remarks:
Doses / Concentrations:
1000 mg/kg/day
Basis:
actual ingested
Remarks:
Doses / Concentrations:
150 mg/kg/day
Basis:
actual ingested
Remarks:
Doses / Concentrations:
25 mg/kg/day
Basis:
actual ingested
Remarks:
Doses / Concentrations:
0 mg/kg/day
Basis:
actual ingested
No. of animals per sex per dose:
5 male and 5 female per dose
Control animals:
yes, concurrent vehicle

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Description (incidence and severity):
There were no unscheduled deaths during the study.
Mortality:
no mortality observed
Description (incidence):
There were no unscheduled deaths during the study.
Body weight and weight changes:
no effects observed
Description (incidence and severity):
No adverse effect on bodyweight development was evident during the study.
Haematological findings:
no effects observed
Description (incidence and severity):
No toxicologically significant effects were detected.
Clinical biochemistry findings:
no effects observed
Description (incidence and severity):
Males treated with 1000 mg/kg/day showed reduced bilirubin levels, females of this treatment group showed elevations in total protein, albumin and cholesterol. No such effects were evident for animals of either sex treated with 150 or 25 mg/kg/day.
Organ weight findings including organ / body weight ratios:
no effects observed
Description (incidence and severity):
Elevated liver weights were evident for animals of either sex treated with 1000 mg/kg/day. Females of this treatment group also showed increased kidney weights.
Gross pathological findings:
no effects observed
Description (incidence and severity):
No toxicologically significant macroscopic abnormalities were detected at terminal kill.
Details on results:
LIVER:
Centrilobular hepatocyte enlargement was observed in relation to treatment for animals of either sex treated with 1000 mg/kg/day. The condition was observed to have regressed among animals of either sex treated with 1000 mg/kg/day following the additional fourteen days treatment-free period.

THYROID:
Follicular cell hypertrophy was observed in relation to treatment for female animals only treated with 1000 mg/kg/day. This was considered to be a marginal effect of treatment and follicular cell hypertrophy is in any event a highly variable background condition in laboratory maintained rats. The condition was observed to have regressed among recovery group animals after completion of the recovery period.

Effect levels

open allclose all
Dose descriptor:
NOAEL
Effect level:
1 000 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs
Dose descriptor:
NOEL
Effect level:
150 mg/kg bw/day (nominal)
Based on:
test mat.
Sex:
male/female
Basis for effect level:
clinical signs

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
The oral administration of the test material to rats for a period of twenty-eight consecutive days, at dose levels of 25,150 and 1000 mg/kg/day resulted in treatment related effects at 1000 mg/kg/day. The effects however, were considered entirely adaptive in nature and considered not to represent an adverse health effect. The "No Observed Adverse Effect Level" (NOAEL) was therefore considered to be 1000 mg/kg/dav.
No treatment related effects were detected in the remaining dose levels therefore the "No Observed Effect Level" (NOEL) was considered to be 150 mg/kg/day.
Executive summary:

The oral administration of the test material to rats for a period of twenty-eight consecutive days, at dose levels of 25,150 and 1000 mg/kg/day resulted in treatment related effects at 1000 mg/kg/day. The effects however, were considered entirely adaptive in nature and considered not to represent an adverse health effect. The "No Observed Adverse Effect Level" (NOAEL) was therefore considered to be 1000 mg/kg/dav. No treatment related effects were detected in the remaining dose levels therefore the "No Observed Effect Level" (NOEL) was considered to be 150 mg/kg/day.