Registration Dossier

Diss Factsheets

Toxicological information

Acute Toxicity: dermal

Currently viewing:

Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Older study; valid results are reported.
Cross-reference
Reason / purpose for cross-reference:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1958

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
GLP compliance:
no
Remarks:
olde study, pre-dates GLP
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Dimethyl terephthalate
EC Number:
204-411-8
EC Name:
Dimethyl terephthalate
Cas Number:
120-61-6
Molecular formula:
C10H10O4
IUPAC Name:
dimethyl terephthalate
Details on test material:
The test substance was manufactured at Tennessee Eastman. The sample was taken from lot no. 27, drum no. 14.

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No further details on test animals and environmental conditions.

Administration / exposure

Type of coverage:
occlusive
Vehicle:
water
Details on dermal exposure:
The test substance was moistened with water and applied to the skin of guinea pigs for 24 hours, and held in place by rubber cuff
Duration of exposure:
24 hours
Doses:
Doses of 0.1 to 5 g/kg
No. of animals per sex per dose:
4 guniea pigs were used in total.
Control animals:
no
Details on study design:
The test substance was moistened with water and applied to the skin of guinea pigs for 24 hours. The skin of the guinea pig was observed for 14 days.
Statistics:
None reported.

Results and discussion

Preliminary study:
No preliminary study
Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 other: g/kg
Based on:
test mat.
Remarks on result:
other: No treatment-related deaths
Mortality:
One animal at 5 g/kg died due to cuffing, there were no treatment-related deaths.
Clinical signs:
other: No local lesions were present. At one week there was sparse hair. By two weeks, the coat of the guinea pig was back to normal.
Gross pathology:
No information to report.
Other findings:
No further findings

Any other information on results incl. tables

No further information to report.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Varying amounts of the solid moistened with water were held in contact with the depilated skin of guinea pigs for a period of 24 hours. Only slight skin irritation was observed and there was no indication that the material was absorbed directly through the intact skin. The LD50 was determined to be >5 g/kg.
Executive summary:

Varying amounts of solid dimethyl terephthalate moistened with water were held in contact with the depilated skin of guinea pigs for a period of 24 hours. Only slight skin irritation was observed and there was no indication that the material was absorbed directly through the intact skin. The LD50 was determined to be >5 g/kg.