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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Bis(2,3-epoxypropyl) cyclohex-4-ene-1,2-dicarboxylate
EC Number:
244-435-6
EC Name:
Bis(2,3-epoxypropyl) cyclohex-4-ene-1,2-dicarboxylate
Cas Number:
21544-03-6
Molecular formula:
C14H18O6
IUPAC Name:
1,2-bis[(oxiran-2-yl)methyl] cyclohex-4-ene-1,2-dicarboxylate
Test material form:
liquid

Test animals

Species:
rat
Strain:
other: Tif: RAIf (SPF) strain
Sex:
male/female
Details on test animals or test system and environmental conditions:
Animals
Healthy random bred rats of the Tif: RAIf (SPF) strain raised on our premises were used for these experiments.
They were kept at a room temperature of 22 + 1° C, at a relative humidity of 55 + 5 % and on a 10 hours light cycle day. They received ad libitum rat food - NAFAG, Gossau SG - and water. Prior to treatment the animals were adapted to our laboratories for a
minimum of 4 days and the initial body weight ranged from 180 to 200 grams.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
Treatment* and observations
During the treatment and observation period the rats were housed individually in Macrolon cages (type 2). Approximately 24 hours before treatment an area on the back of the rats of approximately 60 square cm was shaved with an electric clipper.
For treatment the test material was evenly dispersed on the skin with a syringe and was covered with an occlusive dressing which was fastened around the trunk with an adhesive elastic bandage. After 24 hours the dressing was removed, the skin was
cleaned with lukewarm water and the reaction of the skin was appraised.

*Noakes, D.N. and Sanderson, D.M. A method for determining the dermal toxicity of pesticides, Brit. J. Industr. Med., 26, 59-64, 1969
Duration of exposure:
24 hours
Doses:
3590 and 4640
No. of animals per sex per dose:
5 male and 5 female
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no weight observed
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, gross pathology, signs and symptomes
Statistics:
Not applicable

Results and discussion

Preliminary study:
Not applicable
Effect levels
Key result
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 4 600 mg/kg bw
Based on:
test mat.
Remarks on result:
no indication of skin irritation up to the relevant limit dose level
Mortality:
No mortality occured during the test
Clinical signs:
Within 24 hours after treatment the rats in all osage groups showed sedation, dyspnoea, curved position and ruffled fur. No local skin irritation was seen.
The animals recovered from systemic symptoms within 8 to 14 days. They were submitted at random to a necropsy at the end of the observation period.
Body weight:
Not observed
Gross pathology:
No substance related gross organ changes were seen.
Other findings:
N/A

Any other information on results incl. tables

Rate of death:

                                   Died within
   Concentration % of Formulation     N° of animals 1 hour     24 hours     48 hours     7 days     14 days    
  Dose mg/kg    male female   male female  male  female  male  female  male  female  male  female
 3590  conc.  5  5  0  0  0  0  0  0  0  0  0  0
 4640  conc.  5  5  0  0  0  0  0  0  0  0  0  0
                                        No higher doses were possible

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The acute dermal LD50 of the test item in rats of both sexes observed over a period of 14 days is greater than 4600 mg/kg.
The test material has therefore practically no acute toxicity to the rat by this route of administration.
Executive summary:

The acute dermal LD50 of the test item in rats of both sexes observed over a period of 14 days is greater than 4600 mg/kg.

5 male and 5 females per concentrations were treated at 3590 and 4640 mg/kg with the test item unchanged.

The test site was covered with an occlusive dressing during 24 hours and wascleaned with lukewarm water and the reaction of the skin was appraised.

As no mortality occured during the test, animals were necropsied at the end of 14 days observation period

Signs and symptoms

Within 24 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. No local skin irritation was seen.

The animals recovered from systemic symptoms within 8 to 14 days. They were submitted at random to a necropsy at the end of the observation period.

Killed animals: No substance related gross organ changes were seen.

The acute dermal LD50 of the test item in rats of both sexes observed over a period of 14 days is greater than 4600 mg/kg.

The test material has therefore practically no acute toxicity to the rat by this route of administration.