5-thiazolylmethanol

Repeated dose toxicity: oral

Administrative data

Endpoint:

short-term repeated dose toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 Dec 1994 - 29 Jun 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: done under GLP and OECD method

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

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

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

yes

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

5-thiazolylmethanol

EC Number:

414-780-9

EC Name:

5-thiazolylmethanol

Cas Number:

38585-74-9

Molecular formula:

C4H5NOS

IUPAC Name:

(1,3-thiazol-5-yl)methanol

Test animals

Species:

rat

Strain:

other: Crl:CD(SD)BR

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Labs, MI
- Age at study initiation: ~6wks
- Weight at study initiation: (100 - 130g upon arrival)
- Housing: Hanging stainless steel, ventilated wire-bottomed cages
- Diet: Certified Rodent Chow ad libitum
- Water: free assess to tap water
- Acclimation period: 1 day followed by 5 - 6 days pre-treatment period.

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 71±6
- Humidity (%): Ambient
- Photoperiod (hrs dark / hrs light):12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

Method of administration:
Gavage

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

Dosing formulation assays performed on day 0 and day 21. Formulations were homogeneous and contained 101 - 109% of intended concentrations.

Duration of treatment / exposure:

Test duration: 28 days

Frequency of treatment:

Dosing regime: 1/day for 28 days.

Doses / concentrations

Doses / concentrations 1

Remarks:

Doses / Concentrations:
0 mg/kg
Basis:
other: gavage

Doses / concentrations 2

Remarks:

Doses / Concentrations:
15mg/kg
Basis:
other:

Doses / concentrations 3

Remarks:

Doses / Concentrations:
150mg/kg
Basis:
other: gavage

Doses / concentrations 4

Remarks:

Doses / Concentrations:
500mg/kg
Basis:
other: gavage

No. of animals per sex per dose:

Male: 10 animals at 0 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 10 animals at 500 mg/kg bw/day

Female:10 animals at 0 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 10 animals at 500 mg/kg bw/day

Control animals:

yes, concurrent vehicle

Details on study design:

- Dose selection rationale: based on acute oral toxicity testing results
- Rationale for animal assignment: random

5 additional rats/sex/group were added to control and treatment groups to evaluate 2 week recovery

Examinations

Observations and examinations performed and frequency:

CAGE SIDE OBSERVATIONS: Yes
- Time schedule:twice daily on treatment days

DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: prior to exposure and then twice a day

BODY WEIGHT: Yes
- Time schedule for examinations: prior to treatment and then twice weekly

Results and discussion

Results of examinations

Clinical signs:

no effects observed

Description (incidence and severity):

Zero mortality

Mortality:

no mortality observed

Description (incidence):

Zero mortality

Body weight and weight changes:

no effects observed

Food consumption and compound intake (if feeding study):

no effects observed

Food efficiency:

not examined

Water consumption and compound intake (if drinking water study):

not examined

Ophthalmological findings:

not examined

Haematological findings:

no effects observed

Clinical biochemistry findings:

no effects observed

Urinalysis findings:

no effects observed

Behaviour (functional findings):

not examined

Organ weight findings including organ / body weight ratios:

no effects observed

Gross pathological findings:

no effects observed

Histopathological findings: non-neoplastic:

not examined

Histopathological findings: neoplastic:

not examined

Details on results:

MORTALITY: Zero

Effect levels

Dose descriptor:

NOEL

Effect level:

> 500 mg/kg bw/day (nominal)

Based on:

test mat.

Sex:

male/female

Basis for effect level:

other: no mortality and no observed effects

Target system / organ toxicity

Critical effects observed:

not specified

Applicant's summary and conclusion

Conclusions:

No significant toxicity was observed over the range of doses tested. NOEL is > 500 mg/kg/BW.