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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:
key study
Reliability:
2 (reliable with restrictions)

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:
other: Federal Hazards Substances Act (Revised Federal Register Sept 17 1964)
GLP compliance:
no
Test type:
fixed dose procedure

Test material

Constituent 1
Chemical structure
Reference substance name:
4-[(morpholinothio)thioxomethyl]morpholine
EC Number:
237-335-9
EC Name:
4-[(morpholinothio)thioxomethyl]morpholine
Cas Number:
13752-51-7
Molecular formula:
C9H16N2O2S2
IUPAC Name:
morpholin-4-yl morpholine-4-carbodithioate
Details on test material:
Good-Rite® 3030x18 (Cure-Rite® 18); purity: not noted

Test animals

Species:
rabbit
Sex:
male/female

Administration / exposure

Type of coverage:
semiocclusive
Vehicle:
physiological saline
Details on dermal exposure:
Dose was applied to the abdominal skin area from which the fur had been previously removed with electric clippers. The abdominal skin area of two rabbits in each group was abraded by making a series of longitudinal minor epidermal incisions, sufficiently deep enough to penetrate the epidermis but not to induce bleeding. The two remaining rabbits in each group remained intact.
Duration of exposure:
24 hours initial dosing, followed by 14 days observation period.
Doses:
1.00, 2.15, 4.64 and 10.0 gm/Kg of body weight.
No. of animals per sex per dose:
not specified.
Control animals:
no
Details on study design:
Observation period after administration: 14 days.
Gross necropsies conducted on surviving animals after 14 days: yes.
Starting body weights of all rabbits: 2328 - 2834 gm.

Results and discussion

Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 10 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: no confidence limits were calculated during this study
Mortality:
1 rabbit (Rabbit No. 4) died on day 8 of the observation period, the remaining animals survived to the end of the study.
Clinical signs:
other: other: Observation of Rabbit 4 showed slight emaciation, nasal discharge and wheezing noted on the 6th and 7th post-exposure day. Death followed on day 8. For the remaining animals, a few exhibited slight ataxia at completion of the exposure period only.
Gross pathology:
rabbit number 4 which died showed congested lungs, kidneys and adrenals; abcesses diffusely scattered throughout the lungs; depleted body fat stores; and autolytic alterations.
Gross necropsies performed at termination revealed depleted body fat stores in one rabbit. No other significant pathological alterations were noted.
Other findings:
when the binders where removed after the 24 hour exposure period, varying amounts of moist sample were present on the binders and abdomens of the rabbits, indication incomplete dermal absorption of the applied material.

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: other: Regulations for the Enforcement of the Federal Hazardous Substances Act (revised, Federal Register, September 17, 1964)
Conclusions:
The acute dermal LD50 for albino rabbits was found to be greater than 10.0 g/Kg of body weight.
Executive summary:

Four groups consisting of four rabbits each were exposed to the test substance by dermal exposure at 1.0, 2.15, 4.64 and 10 g/kg bodyweight for a period of 24 hours. At the end of the exposure period, the test substance was washed off, and the test animals were observed for mortality, clinical signs and signs of dermal irritation for a period of 14 days after exposure. At the end of the observation period, all test animals were sacrificed and post mortem examinations were performed.

One rabbit (Rabbit 4) in the 1.0 mg/kg group was found dead on day 8. No other deaths occurred in the test animals during the exposure or observation periods. Observation of Rabbit 4 showed slight emaciation, nasal discharge and wheezing noted on the 6th and 7th post-exposure day. Death followed on day 8. For the remaining animals, a few exhibited slight ataxia at completion of the exposure period only. Emaciation in four rabbits and a purulent nasal discharge in several animals were noted. The surviving rabbits exhibited normal appearance and behavious throughout the study.

The acute lethal dermal dose to rabbits of Cure-rite 18 was found to be greater than 10.0 g/kg bodyweight.