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: Study was conducted in methods comparable to OECD guideline 404. However, animals were only observed immediately after patch removal and at 72 hours.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1965
Report Date:
1965

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
Animals were observed immediately after patch removal and at 72 hours.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 2,6-xylenol
- Physical state: white solid
- Analytical purity: The material was considered to be free of impurities.
- Other: received on April 19, 1965. The test substance has a pungent odor.

Test animals

Species:
rabbit
Strain:
other: albino
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.1 to 2.7 kg.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: both intact and abraded
Vehicle:
unchanged (no vehicle)
Controls:
other: Untreated skin areas were used as control.
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: The test substance was moistened with a small amount of water and applied to six one-inch square patches in the amount of 0.5 grams per patch.
Duration of treatment / exposure:
24 hours
Observation period:
The test sites were observed for irritation 24 and 72 hours after application.
Number of animals:
Six animals were divided into two groups, three with intact and the remaining three with abraded skin.
Details on study design:
TEST SITE
- Area of exposure: designated area on the denuded back
- Type of wrap if used: The trunk of each animal was wrapped with rubberized cloth to keep the patches in place and retard any evaporation of the test substance.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: Following an exposure period of 24 hours, the binders and patches were removed.

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24
Score:
> 1
Reversibility:
other: not reported
Remarks on result:
other: A necrotizing effect was noted at all time points; no dermal irritation score was reported.
Irritant / corrosive response data:
Necrosis was noted on all of the intact and abraded areas at 24 and 72 hours post exposure. The necrotizing effect of the test substance precluded any accurate readings for erythema; therefore it was not possible to determine the primary irritation index of the test substance. Slight to marked edema was observed in most or all exposed sites at each of the observation intervals.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive)
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
A single application of 0.5 grams of 2,6-xylenol to the intact and abraded rabbit skin by a 24-hour patch test produced necrosis and edema on all exposed areas at 24 and 72 hours after application. The test substance was considered to be corrosive and irritating to the skin.