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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
22 June to 25 June 1989
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Proprietary GLP study, in accordance with US EPA guidelines (comparable to OECD 404)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: EPA FIFRA, Pesticide Assessment Guidelines Subdivision F; Hazard Evaluation Human and Domestic Animals Section 81-5 "Primary Dermal Irritation Study"
Qualifier:
according to
Guideline:
other: EPA TSCA Health Effect Test Guidelines; Section HG "Primary Dermal Irritation"
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
use of 6 animals
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Dimethyl terephthalate (DMT) was supplied by Hüls Troisdorf AG in a glass screw top jar. It was described as a white flaky solid, and was stored at room temperature. The identification and stability of the test material were not determined.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The animals were male New Zealand White rabbits supplied by David Percival Ltd. (UK). At the start of the study the animals werighed 2.27 -3.04 kg and were approximately 12-16 weeks old. They were acclimatised for a minimum of 5 days. Individuals were identified by black indelible marker pen numbers written on the inner surface of the ear.
The rabbits were individually housed in suspended metal cages. Free access to mains drinking water and food (Rabbit Diet, Preston Farmers Ltd., UK) was allowed throughout the study
The animal room was maintained at a temperature of 17-21°C and relative humidity of 55-57%. There were approximately 15 air changes per hour and the lighting was controlled to give 12 hours light and 12 hours dark.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
water
Controls:
no
Amount / concentration applied:
0.5 g test material moistened with 0.5 ml distilled water.
Duration of treatment / exposure:
Four hours
Observation period:
72 hours after patch removal
Number of animals:
Six
Details on study design:
Approximately 24 hours prior to the start of the test, the rabbits were clipped free of fur from the dorsal/flank area using veterinary clippers. Only animals with a healthy intact epidermis by gross observation were selected for the study.
On the day of the test a suitable test site was selected on the back of each rabbit. 0.5 g of the moistened test material was introduced under a 2.5 cm² gauze patch and placed in position on the shorn skin. The patch was secured in position by a strip of adhesive tape (Blenderm). The trunk of each rabbit was then wrapped in an elasticated corset and the animals were returned to their cages.
Four hours after application the wrappings and patches were removed and any residual test material removed by gentle swabbing with cotton wool soaked in diethyl ether.
The test sites were examined for evidence of primary irritation 1 hour after patch removal, and 24, 48 and 72 hours later. The Draize (1959) scale was used (see below).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: Mean 1, 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not applicable
Remarks on result:
other: no reactions recorded
Irritation parameter:
edema score
Basis:
mean
Time point:
other: Mean 24, 48 and 72 hours
Score:
0
Max. score:
0
Reversibility:
other: not relevant
Remarks on result:
other: no reactions recorded
Irritant / corrosive response data:
No signs of irritation were observed in any rabbit at any time point.
Other effects:
No other effects reported.

Any other information on results incl. tables

No further details.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
Dimethyl terephthalate was not irritating to the skin of rabbits under the conditions of this study.
Executive summary:

The irritant potential of Dimethyl terephthalate (DMT) was determined according to ES EPA guidelines. A single 4 hour, semi-occluded application of DMT to the skin of six male New Zealand White rabbits produced no evidence of skin irritation. The test material produced a primary index of 0.0 and is not classified as irritating to rabbit skin.