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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:
09 May - 30 June, 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:
other: Directive 92/69/EEC, Method B3 Part 3
GLP compliance:
yes
Test type:
standard acute method

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
414-490-2
EC Name:
-
Cas Number:
154212-59-6
Molecular formula:
C11H9ClN2O5S
IUPAC Name:
4-nitrophenyl 1,3-thiazol-5-ylmethylcarbonate hydrochloride

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 Rivers, MI for males, Raleigh, NC for females.
- Age at study initiation: eight to ten weeks
- Weight at study initiation: 227 - 291 g
- Fasting period before study: n/a
- Housing: ventilated stainless steel hanging cages.
- Diet: Certified Rodent Chow ad libitum
- Water : ad libitum
- Acclimation period: Eight days

ENVIRONMENTAL CONDITIONS
- Temperature (°F): 70 -72°
- Humidity (%): ambient
- Photoperiod (hrs dark / hrs light): 12 hrs light/12hrs dark

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
water
Details on dermal exposure:
TEST SITE
- Area of exposure: 50 x 50mm

REMOVAL OF TEST SUBSTANCE
- Washing (if done):
- Time after start of exposure:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):

VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
Duration of exposure:
24 hours
Doses:
2g/kgBW
No. of animals per sex per dose:
5 males/5 females
Details on study design:
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- Duration of observation period following administration: 14 days
- Frequency of observations: Daily
- Frequency of weighing: Weekly
- Necropsy of survivors performed: yes

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No rats died during study
Clinical signs:
except for pale eyes in a single female rat on day 3 of observation, there was no irritation at the treatment site
Body weight:
No apparent treatment related effects on body weight were observed during 2 week observation period.
Gross pathology:
No apparent treatment related effects on gross pathology were observed during 2 week observation period.
Other findings:
Very slight to slight erythema and multiple small scabsat the site of exposure were noted in nearly all male and female rats. Very slight to slight edema at the exposure site were noted in three females and scaling of the skin in two females.

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 (LD50) to rats was demonstrated to be greater than the limit dose of 2mg/kg bodyweight