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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
equivalent or similar to guideline
other: US OSHA: 16 CFR 1500.41
Principles of method if other than guideline:
Protocol according to U.S. FHSA: occlusive exposure of intact and abraded skin for 4 hours.
GLP compliance:

Test material

Constituent 1
Test material form:
Details on test material:
Yellowish Brown Liquid

Test animals

New Zealand White
Details on test animals or test system and environmental conditions:
Animals for this test were subjected to no other experimentation prior to the study. Animals selected were obtained from a larger pool of other animals and were examined to ensure that their skin was free from irritation, trauma, and disease.
They were sourced from Eastern Rabbit Breeding Laboratories, Taunton, MA, USA. They weighed 2-3 kg at the start of the study and were 10-12 weeks of age.
Animals were housed individually using suspended stainless steel cages. Hardwood chips were used for non-contact bedding under the cages.
Animal rooms were maintained at 68±3 deg. F, with Humidity maintained at 30-70%. A 12 hour light/dark cycle was used

All animals were supplied with a commerical rabbit ration and municiple tap water ad libitum.
Upon receipt, all animals were housed in quarantine for a period of 4 days under the same conditions as the actual test.

Test system

Type of coverage:
Preparation of test site:
other: intact and abraded
unchanged (no vehicle)
Amount / concentration applied:
The test material applied was introduced under a guaze pad two layers thick, measuring 2.5cm x 2.5cm, which were held together by an impervious (occlusive) bandage.
Duration of treatment / exposure:
Skin was exposed to the test material for a 4 hour period
Observation period:
After test material was removed, the test sites were monitered for signs of irritation at 24 and 72 hours.
Number of animals:
3 males and 3 females.
Details on study design:
Test and control sites of each rabbit were clipped of all hair around the trunk.
One application site of each animal was abraded by making minor incisions through the stratum corneum, but not sufficient enough to disturb the derma.The second application site was intact skin.
The animals were treated by introducing the test substance to the skin using a gauze pad 2.5 cm x 2.5 cm, and was held together by an impervious bandage.
The test material was held to the skin for a period of four hours before it was removed and cleaned of any excess material.
Each animal served as its own control (untreated site).
At the end of the study (72 h after application), the animals were weighed and euthanised with a barbiturate (Euthanasia-5, Verterinary Labortories Inc., Topeka, KS).

Results and discussion

In vivo

Irritation parameter:
primary dermal irritation index (PDII)
Time point:
24/48 h
Max. score:
not specified
Remarks on result:
no indication of irritation

Any other information on results incl. tables

None of the test sites of any animal at any time during the study showed signs of erythema or edema, whether the skin was abraded or intact.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
The test material was found to be non-irritating to the skin of New Zealand Rabbits after occlusive exposure of intact and abraded skin to 4-phenylpropylpyridine for 4 hours.