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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to the O.E.C.D. test guideline 404 with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: viscous
Details on test material:
As per IUCLID Sections 1.1. 1.2. and 4.1.

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
The animals were acquired from Kleintierfarm Madoerin AG CR 4414 Fuellinsdorf / Switzerland were 14-15 weeks old and weighed 2.4-2.6 Kg. The animals were maintained Individually in stainless steel cages equipped with an automatic cleaning and drinking system (Dipl. Ing. W. Ehret GmbH, Versuchstiertechnik, 0—7830 Emmendingen / FRG). The rabbits were allowed access to Pelleted standard Kliba 341, rabbit maintenance diet (°Kliba, Klingentalmuehle AG, 4303 Kaiseraugst, Switzerland) and water ad libitum. The animal room was air-conditioned with 10—15 air changes per hour and hourly monitored environment with temperature 20+—3 degrees centigrade, relative humidity 40—70%, 12 hours
artificial fluorescent light/12 hours dark/light period. The animals were acclimated to laboratory conditions for four days before being placed on-study.


Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
0.5 mL
Duration of treatment / exposure:
3 min, 1 hr and 4 hr
Observation period:
1, 24, 48 and 72 hours
Number of animals:
3
Details on study design:
On the day before the test each rabbit was 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. One rabbit was initially treated. Three suitable sites were selected on the back of the
rabbit. A quantity of 0.5 ml of the test item was applied directly to the skin under a 2.5 cm x 2.5 cm cotton gauze patch. Each patch was secured in position with a strip of surgical adhesive tape. To prevent the animal interfering with the patches, the trunk of the rabbit was wrapped in an elasticated corset for the duration of the exposure period.

Results and discussion

In vivo

Results
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
other: all time points
Score:
ca. 0
Reversibility:
fully reversible within: not irritating

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The Primary Irritation Index of 0 suggests that the test substance is "not irritanting" to the skin. The study data does not support Classification and Labeling as a skin irritant.
Executive summary:

The test substance, 4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with fatty acids, C18-unsatd., dimers was evaluated for skin irritation potential in an O.E.C.D. Test Guideline no 404 study. The Primary Irritation Index of 0 observed in the suggests that the test substance is "not irritanting" to the skin. The study data does not support Classification and Labeling as a skin irritant.