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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
10 Nov - 25 Nov 2010
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report date:
2010

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
EPA OPPTS 870.1200 (Acute Dermal Toxicity)
Qualifier:
according to guideline
Guideline:
other: EC 440/2008
GLP compliance:
yes (incl. QA statement)
Remarks:
Bayerisches Landesamt für Gesundheit und Lebensmittelsicherheit, München, 2008
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tris(oxiranylmethyl) benzene-1,2,4-tricarboxylate
EC Number:
230-638-7
EC Name:
Tris(oxiranylmethyl) benzene-1,2,4-tricarboxylate
Cas Number:
7237-83-4
Molecular formula:
C18H18O9
IUPAC Name:
tris(oxiranylmethyl) benzene-1,2,4-tricarboxylate
Details on test material:
- Name of test material (as cited in study report): Tris(oxiranylmethyl)benzene-1,2,4-tricarboxylate
- CAS No. (as cited in study report): 7237-83-4
- Purity: 81.8%
- Batch No.: Baj Hj 04
- Expiry Date: Jan 06, 2012
- Physical state at RT: liquid
- Appearance: light yellow liquid
- Storage condition of test material: at room temperature, protected from light

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Charles River, 97633 Sulzfeld, Germany
- Age at study initiation: males: 9-10 weeks, females: 13 weeks old
- Weight at study initiation: males: 265-273 g, females 212-254 g
- Housing: IVC cages, type III H, polysulphone cages on Altromin saw fibre bedding (lot no. 050810)
- Diet (ad libitum): free access to Altromin 1324 for rats and mice (lot no. 1315)
- Water (ad libitum): free access to tap water, sulphur acidified to a pH value of approx. 2.8
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/- 3
- Humidity (%): 55 +/- 10
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: dorsal trunk area
- % coverage: Not less than 10% of the body surface
- Type of wrap if used: gauze dressing and non-irritating tape and fixation with an additional dressing.

REMOVAL OF TEST SUBSTANCE
At the end of the exposure period the residual test item was removed by using aqua ad injectionem.

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw; volume was not given.
- Concentration (if solution): undiluted test item ws applied

Approx. 25 h before testing, the fur was removed from the dorsal area of the trunk using an electric clipper. Only animals with healthy intact skin were used.
Duration of exposure:
24 h
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5 males and 5 females
Control animals:
not required
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations: after 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours on the day of exposure and daily thereafter.
- Frequency of weighing: On days 1, 8 and 15
- Necropsy of survivors performed: yes, all animals
- Other examinations performed: skin irritation was assessed daily during the observation period using the Draize scale as laid down in OECD Guideline 404.
Statistics:
no statistical analysis was performed

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No deaths occurred.
Clinical signs:
No signs of toxicity observed.
No erythema or edema was observed in any of the treated animals at any observation interval.
Body weight:
All male animals showed the expected gain in body weight. Two female animals showed minimal body weight reduction at the end of the observation period.
Gross pathology:
No treatment-related effects were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Under the conditions of the present study, single dermal application of the test item tris(oxiranylmethyl)benzene-1,2,4-tricarboxylate to rats at a dose of 2000 mg/kg body weight was associated with no mortality, no clinical signs and no signs of irritation.
Executive summary:

Male and female rats (WISTAR) were treated dermally by semi-occlusive application during 24 hours at a dosage of 2000 mg/kg body weight. The test item was applied undiluted. The animals were observed 30 minutes, 1h, 2h, 3h and 4h after the start of dosing and then once daily for 14 days. The animals were weighed on day 1 (prior to the application) and on days 8 and 15.

No deaths occurred during the course of the study.No signs of toxicity as well as no signs of irritation were observed during the course of the study.

No abnormal body weight changes were noted.

At necropsy, no changes were noted.

The acute dermal median lethal dose (LD50) of tris(oxiranylmethyl)benzene-1,2,4-tricarboxylate in rats is greather than 2000 mg/kg body weight.

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