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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Between 2003-07-28 and 2003-09-26
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline and GLP study with no deviations.
Cross-referenceopen allclose all
Reason / purpose for cross-reference:
reference to same study
Reason / purpose for cross-reference:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2003
Report date:
2003

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Principles of method if other than guideline:
NA
GLP compliance:
yes (incl. QA statement)
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Reference substance name:
-
EC Number:
451-530-8
EC Name:
-
Cas Number:
736150-63-3
Molecular formula:
Not applicable
IUPAC Name:
Not allocated
Details on test material:
Name of test material (as cited in study report): TS-ED 532
- Lot/batch No.: batch 10102
- Expiration date of the lot/batch: 2003-11-23

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Rat
- Age at study initiation: 8 weeks (males) and 12 weeks (females)
- Weight at study initiation: 230-264 g (male) and 195-205 g(female)
- Fasting period before study: none
- Housing: During acclimatization in groups of five per sex. Individually during treatment and observation
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: a week before treatment

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 20-70%
- Air changes (per hr): 10-15
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
corn oil
Details on dermal exposure:
TEST SITE
- Area of exposure: skin
- % coverage: 10% of total body surface
- Type of wrap if used: semiocclusive dressing fixed with an elastic adhesive bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL
- Concentration (if solution): 0.5 g/mL
- Constant volume or concentration used: yes
- For solids, paste formed: no

VEHICLE
- Amount(s) applied (volume or weight with unit): 4 mL
- Concentration (if solution): 0.5 g/mL
- Lot/batch no. (if required): 37255780
- Purity: No information
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 male/female per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality/viability and clinical signs recorded daily during acclimatization period. Mortality/viability
recorded twice daily during days 1-15, clinical signs recorded 1, 2, 3 and 5 h after treatment on day 1 and once daily during days 2-15, bodyweight recorded on day 1 (prior to administration), day 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight and macroscopic examinations
Statistics:
No statistical analysis was used

Results and discussion

Preliminary study:
NA
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
No clinical signs were observed.
Body weight:
The body weight of the animals was within the range commonly recorded for this strain and age.
Gross pathology:
No macroscopic findings were observed at necropsy.
Other findings:
No local signs of toxicity were observed.

Any other information on results incl. tables

NA

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal toxicity of TS-ED 532 was tested in rats by dermal application. Based on the results, it is concluded that the acute dermal toxicity of TS-ED 532 is larger than 2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of TS-ED 532 was tested in five male and five female rats by dermal application. TS-ED 532 was diluted in vehicle (corn oil) to a concentration of 0.5 g/mL and administered at a dosage volume of 4 mL/kg bw leading to a final dose level of 2000 mg/kg bw. TS-ED 532 was administered as a single dermal application for 24 h using semi-occlusive technique followed by an observation period of 14 days. Mortality/viability, clinical signs and body weights were recorded during the study. All animals were necropsied and examined macroscopically.

No deaths occurred during the study and no clinical signs were seen. The bodyweights were within normal range and there were no macroscopic findings at necropsy.

It is concluded that the LD50 for acute dermal toxicity of TS-ED 532 is larger than 2000 mg/kg bw. Based on this result, TS-ED 532 is not classified according to EU criteria.

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