Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
6 March to 31 May 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Proprietary non-GLP study conducted according to internal SOP, comparable to current guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Principles of method if other than guideline:
The study was comparable to the OECD guideline. The authors report that there were no deviations from the SOP.
GLP compliance:
no
Remarks:
The study was not GLP, however it was subject to a quality assurance inspection
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
2-Butyl-2-ethyl-1,3-propanediol (synomyns BEPD; PM-17173; DMH; and Dimethylolheptane), obtained from the Texas Eastman Company, batch number TX-1818-87. The test substance was in solid form.

Test animals

Species:
rat
Strain:
other: CD(SD)BR VAF/Plus
Sex:
male/female
Details on test animals and environmental conditions:
The animals were male and female CD(SD)BR VAF/Plus rats, with an initial body weight range of 153-163 g in males, and 158-171 g in females. Individuals were identified by metal ear tages and cage number.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
unchanged (no vehicle)
Details on dermal exposure:
The test substance was moistened with distilled water prior to application. The hair was removed from the skin of the rats with electric clippers. A single dose was applied and an occlusive wrap was sued to hold the test substance against the skin for 24 hours. At the end of the exposure period the application site was washed with running water.
Duration of exposure:
24 hours
Doses:
2000 mg/kg bw
No. of animals per sex per dose:
10 rats (5 males and 5 females)
Control animals:
no
Details on study design:
Following the exposure period, the rats were observed for clinical signs and mortality for 2 weeks. Body weight gain was measured weekly. Surviving rats were sacrificed at the end of the 14 day observation period and subjected to gross necropsy.
Statistics:
Statistics were not necessary (limit test; only 1 dose used).

Results and discussion

Preliminary study:
Not required
Effect levels
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
There were no mortalities during the exposure period or the 14 day observation period.
Clinical signs:
No abnormal clinical signs were observed.
Body weight:
All rats gained weight during the 14 day observation period.
Gross pathology:
No treatment-related changes were observed at necropsy. All other lesions observed at necropsy were not considered treatment-related and no tissue was collected for microscopic examination.
Other findings:
No other findings were reported.

Any other information on results incl. tables

The authors concluded that based on weight gain, survival and the absence of clinical signs, no signs of percutaneous absorption (leading to systemic toxicity) were evident.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The acute dermal LD50 of BEPD to rats is >2000 mg/kg bw.
Executive summary:

The acute dermal toxicity of 2 -Butyl-2 -ethyl-1,3 -propanediol (BEPD) was determined in a limit test with 5 male and 5 female CD(SD)BR VAF/Plus rats. The test substance was applied (after moistening with distilled water) to the shaved skin of the rats, in a single dose of 2000 mg/kg bw. The test substance was held in place for 24 hours under an occlusive dressing, the skin was washed following dressing removal. There were no mortalities, and no abnormal clinical signs were noted during 14 day observation period, and all rats gained weight. There were no treatment-related findings at gross necropsy. The authors concluded that based on weight gain, survival and the absence of clinical signs, no signs of percutaneous absorption (leading to systemic toxicity) were evident. Based on the results obtained in this study, the acute dermal LD50of BEPD to rats is >2000 mg/kg bw.