Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study, pre-dates OECD guidelines, limitations in reporting but acceptable design.
Justification for data waiving:
other:
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1980
Report Date:
1980

Materials and methods

Principles of method if other than guideline:
Rabbit patch test
Based on: Code of Federal Regulations, Title 16, Section 1500.41
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
Substance: p-Phenylphenol

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: laboratory animal breeder W. Ostrop / Meerbusch
- Housing: The animals were housed individually in cages
- Weight: average weight of 2.8 kg
- Diet (e.g. ad libitum): provided with “Mümmel Z” feed (ssniff / Soest) ad libitum
- Water (e.g. ad libitum): water ad libitum

ENVIRONMENTAL CONDITIONS (Rearing conditions)
- Temperature (°C): 16 -18
- Humidity (%): 40 (relative humidity)
- Photoperiod (hrs dark / hrs light): 12 - hour light/dark cycle

- Other:
- Male rabbits.
- Habituation period 7 - 14 d.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: left and right rump clipped and right side abraded
Vehicle:
other: oil used to form a paste
Controls:
not required
Amount / concentration applied:
500 mg of the substance mixed with oil to form a paste
Duration of treatment / exposure:
24 hour
Observation period:
Findings were recorded immediately (approx. 30 min) after removal of the patches (24-hour reading), and then 48h and 72h after the start of the test (48h after the first reading). The 48h reading does not appear in the report sheet. The control findings after 8d are not taken into account in calculating the irritation index.
Number of animals:
6
Details on study design:
Test execution: 24 hours before the start of the test, an area of flank skin measuring approx. 8 x 8 cm on either side of the rump of 6 rabbits with an average weight of 2.8 kg was shaved using electric hair clippers. The skin on the right flank was additionally scratched with the aid of a scarificator in the area where the test patches were to be applied. 2.5 x 2.5 cm patches of double - layered surgical gauze were coated with/soaked in 500 mg of the substance mixed with oil to form a paste and covered with inert, impermeable PVC film (5 x 5 cm).

The film with the patches underneath it was attached to the two test areas with the aid of skin - friendly adhesives strips (Leukoflex). Then the animal’s entire rump was wrapped in elastic bandage (EloflexR) for the duration of the 24 - hour exposure time. The animals were immobilised.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 72 hours
Score:
1.1
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 72 hours
Score:
2
Max. score:
4
Reversibility:
not fully reversible within: 8 days

Any other information on results incl. tables

- See attached report for Results - individual scores - total score - PRIMARY SKIN IRRITATION in rabbits

- Primary irritation index: 13.0 / 4 = 3.3

- Classification: moderate irritant

Applicant's summary and conclusion

Interpretation of results:
irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The product is thus classified as a moderate irritant to the skin.
Executive summary:

- The aforementioned product yielded a primary irritation index of 3.3 in the primary skin irritation study conducted in accordance with Code of Federal Regulations, Title 16, Section 1500.41.

- The product is thus classified as a moderate irritant to the skin.