Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-10-18 to 2010-11-03
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
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:
EU Method B.3 (Acute Toxicity (Dermal))
Deviations:
no
Qualifier:
according to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
but without influence (see section Overall remarks)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Diethyl oxalate
EC Number:
202-464-1
EC Name:
Diethyl oxalate
Cas Number:
95-92-1
Molecular formula:
C6H10O4
IUPAC Name:
diethyl oxalate
Test material form:
other: colourless oily liquid
Details on test material:
- Name of test material: Diethyloxalate

Test animals

Species:
rat
Strain:
other: Wistar Han
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Source: Breeding farm VELAZ s.r.o., Koleč u Kladna, Czech Republic, RČH CZ 21760152
- Weight at study initiation: 212-253 g
- Housing: animal room with monitoring conditions – one animal in one plastic cage
- Diet: ST 1 BERGMAN – standard pelleted diet ad libitum
- Water: drinking tap water ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C, permanently monitored
- Humidity: 30 – 70 %, permanently monitored
- Air changes: approximately 15 air changes per hour
- Photoperiod: 12-hour light/dark cycle

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
TEST SITE
- Area of exposure: 6x6 cm
- % coverage: 10%
- Type of wrap if used: covered by mull and held in contact by plaster (strapping)

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 hours p.a. with water

TEST MATERIAL
The substance was applied undiluted. The amount of test substance for each animal was weighed out (according to its body weight and the dose) immediately before application.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
5
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days

- Frequency of weighing: The animals were weighed at the start of the study (before application), at 8th day and at the end of experiment (15th day).

- Frequency of observations: The first day - twice (30 minutes and 3 hours after application), the second day - twice (in the morning and in the afternoon) and daily thereafter for 14 days. Observations included changes in skin and fur, eyes, visible mucous membranes, nutritive condition, autonomic and central nervous systems, psychic activity, somatomotor activity, reactions to stimuli, function of respiratory, circulatory, digestive and urogenital system. Also the presence of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma was carefully observed.

- Necropsy of survivors performed: All test animals surviving to the end of study were sacrificed on the 15th day by prolonged ethereal narcosis, and gross necropsy was carried out. Nutritional state, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Based on:
test mat.
Mortality:
No death of animals was observed during the 14 days observation period.
Clinical signs:
No clinical signs of intoxication were observed.
Body weight:
Body weight development was not affected.
Gross pathology:
Macroscopic changes in kidneys (increase in size, changes of colour, granular or rough surface) were diagnosed during the pathological examinations in four male and all female animals.
Other findings:
On the basis of the gross pathological examinations, histopathological examinations of the kidneys from one male and one female animal were performed. Urolithiasis, interstitial inflammation and expansive foci were observed at these histopathological investigations in the kidneys.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met