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Diss Factsheets

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
14 Mar 1995 - 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
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
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
Details on test material:
Abbott-87440

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 Laboratories Inc.
- Age at study initiation: 8 to 9 weeks
- Weight at study initiation: 190 to 217g
- Housing: Individual stainless steel hanging cages
- Diet :Certified Rodent Chow, ad libitum
- Water: ad libitum
- Acclimation period: min 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 68° to 70°
- Photoperiod (hrs dark / hrs light): 12hrs/12hrs

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 x 50mm
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): applied to the shaven back of each animal

Duration of exposure:
24 hr
Doses:
2g/kgbw
No. of animals per sex per dose:
seven male and five female
Details on study design:
All rats observed frequently on day of treatment and daily for 13 days for total of 14 days.
All animals weighed prior to dosing and weekly thereafter.
Necropsy of survivors performed: yes, 2 weeks after treatment.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
>= 2 000 mg/kg bw
Based on:
test mat.
Mortality:
Male: 2,000 mg/kg bw; Number of animals: 7; Number of deaths: 0
Female: 2,000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
other: Except for red discharge noted from the nares of most animals on the day of treatment, no overt signs of toxicity or signs of irritation at the topical application site were observed in male or female rats in this study.
Gross pathology:
no effect

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute lethal dermal dose to rats was demonstrated to be >2,000 mg/kg bodyweight