Registration Dossier

Administrative data

Endpoint:
short-term repeated dose toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
No data
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was conducted prior to GLP and test guidelines, but sufficient data is available for interpretation of results.
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:
1993

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The skin irritation test included topical application of 0.5 ml of neat Dowfax 2A1 to the ear, and to intact and abraded skin on the abdomen of a male New Zealand White (NZW) rabbit. The animal was bandaged for 24 hours after application of the test material to provide occlusion and prevent grooming of the application site. Twenty four hours after application the bandage was removed and the application sites were graded. Five consecutive daily doses of Dowfax 2A1 were applied to the intact abdominal skin, and the apex of the left pinna, and three consecutive daily applications to the abraded abdominal site. Observations were recorded up to 72 hours after the final dose.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Test material: Dowfax 2A1
Source: Specialty Chemicals, The Dow Chemical Company
Properties: Amber liquid
pH= 7.0

Test animals

Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals and environmental conditions:
No additional data

Administration / exposure

Type of coverage:
other: ear- open; intact and abraded abdomen- occluded
Vehicle:
unchanged (no vehicle)
Details on exposure:
The skin irritation test included topical application of 0.5 ml of neat Dowfax 2A1 to the ear, and to intact and abraded skin on the abdomen of a male New Zealand White (NZW) rabbit. The animal was bandaged for 24 hours after application of the test material to provide occlusion and prevent grooming of the application site. Twenty four hours after application the bandage was removed and the application sites were graded
Analytical verification of doses or concentrations:
no
Details on analytical verification of doses or concentrations:
Not applicable
Duration of treatment / exposure:
24 hours
Frequency of treatment:
Five consecutive daily doses of Dowfax 2A1 were applied to the intact abdominal skin, and the apex of the left pinna, and three consecutive daily
applications to the abraded abdominal site.
Doses / concentrations
Remarks:
Doses / Concentrations:
0.5 ml
Basis:
other: amount applied
No. of animals per sex per dose:
1
Control animals:
no
Details on study design:
The skin irritation test included topical application of 0.5 ml of neat Dowfax 2A1 to the ear, and to intact and abraded skin on the abdomen of a male New Zealand White (NZW) rabbit. The abdomen of the rabbit was shaved with a straight razor at least three days prior to test initiation. The animal was
bandaged for 24 hours after application of the test material to provide occlusion and prevent grooming of the application site. Twenty four hours
after application the bandage was removed and the application sites were graded. Five consecutive daily doses of Dowfax 2A1 were applied to the intact abdominal skin, and the apex of the left pinna, and three consecutive daily applications to the abraded abdominal site. The study was terminated 72 hours after the final dose.
Positive control:
None

Examinations

Observations and examinations performed and frequency:
Twenty four hours after application the bandage was removed and the application sites were graded. Observations were recorded out to 72 hours after the last dose.
Sacrifice and pathology:
No data
Other examinations:
None
Statistics:
None

Results and discussion

Results of examinations

Clinical signs:
no effects observed
Dermal irritation:
effects observed, treatment-related
Mortality:
no mortality observed
Body weight and weight changes:
not specified
Food consumption and compound intake (if feeding study):
not examined
Food efficiency:
not examined
Water consumption and compound intake (if drinking water study):
not examined
Ophthalmological findings:
not examined
Haematological findings:
not examined
Clinical biochemistry findings:
not examined
Urinalysis findings:
not examined
Behaviour (functional findings):
not examined
Organ weight findings including organ / body weight ratios:
not examined
Gross pathological findings:
not examined
Histopathological findings: non-neoplastic:
not examined
Histopathological findings: neoplastic:
not examined
Details on results:
The animal survived the test period. No clinical signs indicative of systemic toxicity were observed.

No irritation was observed on the ear. Very slight erythema was observed at the intact site after the last application. Very slight erythema was observed at the abraded site on test day two through test day five. The study was terminated 72 hours after the final dose.

Target system / organ toxicity

Critical effects observed:
not specified

Any other information on results incl. tables

None

Applicant's summary and conclusion

Conclusions:
No irritation was observed on the ear. Very slight erythema was observed at the intact site after the last application. Very slight erythema was observed at the abraded site on test day two through test day five. The study was terminated 72 hours after the final dose.
Executive summary:

The skin irritation test included topical application of 0.5 ml of neat Dowfax 2A1 to the ear, and to intact and abraded skin on the abdomen of a male New Zealand White (NZW) rabbit. Five consecutive daily doses of Dowfax 2A1 were applied to the intact abdominal skin, and the apex of the left pinna, and three consecutive daily applications to the abraded abdominal site. No irritation was observed on the ear. Very slight erythema was observed at the intact site after the last application. Very slight erythema was observed at the abraded site on test day two through test day five. The study was terminated 72 hours after the final dose.