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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:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: Study of Industrial Bio-Test Laboratories (IBT).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1971
Report date:
1971

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
yes
Remarks:
only 2 animal/sex and dose
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Oxydiethylene bis(chloroformate)
EC Number:
203-430-9
EC Name:
Oxydiethylene bis(chloroformate)
Cas Number:
106-75-2
Molecular formula:
C6H8Cl2O5
IUPAC Name:
oxydiethane-2,1-diyl dichlorocarbonate
Details on test material:
Purity of the test material was not indicated

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male/female
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.44 - 2.90 kg
- food and water: ad libidum
- Acclimation period: at least 7 days

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Duration of exposure:
24 h
Doses:
2.0, 3.0, 4.6, 6.8 g/kg bw
No. of animals per sex per dose:
2
Control animals:
not specified
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weighing prior to treatment and at 14 days (if still alive)
- Necropsy of survivors performed: on day 14

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
3 400 mg/kg bw
Mortality:
None of the animals treated with 2.0 g/kg died, but all weighed less at 14 days than at the beginning of the study. The two males treated with 3.0 g/kgand two males and 1 female treated with 4.6 g/kg died within 3 days oftreatment. Whereas the survivors treated with 3.0 mg/kg gained a slight amount of weight (50-100 g) over the 14 day observation period, the survivor treated with 4.6 mg/kg lost a slight amount of weight (80 g). All animals treated with 6.8 mg/kg died within 2 days of treatment.
Clinical signs:
No untoward behavioral reactions were noted. Pale red to red, well-defined erythema, moderate edema and burns were noted at the test site after 24 hours. Superficial escharosis was noted 6 days after treatment. The skin began to slough at 14 days
Body weight:
None of the animals treated with 2.0 g/kg died, but all weighed less at 14 days than at the beginning of the study. The two males treated with 3.0 g/kgand two males and 1 female treated with 4.6 g/kg died within 3 days oftreatment. Whereas the survivors treated with 3.0 mg/kg gained a slight amount of weight (50-100 g) over the 14 day observation period, the survivor treated with 4.6 mg/kg lost a slight amount of weight (80 g). All animals treated with 6.8 mg/kg died within 2 days of treatment.
Gross pathology:
No gross pathologic alterations other than the dermal alterations.

Any other information on results incl. tables

None of the animals treated with 2.0 g/kg died, but all weighed less at 14 days than at the beginning of the study. The two males treated with 3.0 g/kg and two males and 1 female treated with 4.6 g/kg died within 3 days of treatment. Whereas the survivors treated with 3.0 mg/kg gained a slight amount of weight (50-100 g) over the 14 day observation period, the survivor treated with 4.6 mg/kg lost a slight amount of weight (80 g). All animals treated with 6.8 mg/kg died within 2 days of treatment.

No untoward behavioral reactions were noted. Pale red to red, well-defined erythema, moderate edema and burns were noted at the test site after 24 hours.  Superficial escharosis was noted 6 days after treatment. The skin began to slough at 14 days. Necropsies of all animals did not reveal any gross pathologic alterations other than the dermal alterations.

Applicant's summary and conclusion