Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
disregarded due to major methodological deficiencies
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
This study was conducted according to guidelines and was GLP. However, the substance has a BP of approximately 30°C and would exist as a vapour at biological temperatures. Therefore, a reliable skin irritation test is not feasible for this substance, based on physical-chemical properties.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2007
Report Date:
2007

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
Qualifier:
according to
Guideline:
EPA OPPTS 870.2500 (Acute Dermal Irritation)
Deviations:
no
Remarks:
The study was conducted according to the guideline in effect at the time of study conduct.
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity: 100% (based on GC analysis)

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
other: The adjacent areas of untreated skin were used for comparison.
Duration of treatment / exposure:
4 hours
Observation period:
up to 72 hours
Number of animals:
3 females

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 0 - 72 hours after removal of test substance
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 0 - 72 hours after test substance removal
Score:
0
Max. score:
4
Other effects:
No clinical signs of toxicity were observed. One of the rabbits exhibited weight loss of approximately 2% of initial weight by 3 days after dosing. No weight loss was observed in the other rabbit.

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, the test substance is not a skin irritant.
Executive summary:

The test substance was applied as a single 0.5-mL dermal dose to the shaved intact skin of a single New Zealand White rabbit. Since no corrosion occurred, 2 additional rabbits were treated. The test substance was applied to a 6 cm2 area of skin. The application area was covered with a 2-ply gauze square which was held in place with non-irritating tape and covered with porous tape for a semi-occlusive dressing. The rabbits were exposed to the test substance for 4 hours after which the test substance was removed. Test sites were evaluated by Draize for signs of dermal irritation approximately 60 minutes, and 24, 48, and 72 hours after test substance removal. The rabbit that was initially treated was also examined immediately after test substance removal.

The rabbits exhibited no dermal irritation during the study. No clinical signs of toxicity were observed. One of the rabbits exhibited body weight loss of approximately 2% of initial weight by 3 days after dosing. No weight loss was observed in the other rabbit. Under the conditions of this study, the test substance is not a skin irritant.